handbook on automated sphygmomanometers
TRANSCRIPT
Handbook on Automated Sphygmomanometers
APEC/APLMF Training Courses in Legal Metrology (CTI 11/2006T)
July 17 – 21, 2006 Taipei, Chinese Taipei
APEC Secretariat 35 Heng Mui Keng Terrace Singapore 119616. Tel: +65-6775-6012, Fax: +65-6775-6013 E-mail: [email protected] Website: www.apec.org
APLMF Secretariat AIST Tsukuba Central 3-9 1-1-1 Umezono, Tsukuba, Ibaraki 305-8563, Japan Tel: +81-29-861-4362, Fax: +81-29-861-4393 E-mail: [email protected] Website: www.aplmf.org
© 2006 APEC Secretariat APEC# 206-CT-04.2 ISBN 9903094-4-8
February 2007
Asia-PacificLegal Metrology Forum
Seminar on Automated Sphygmomanometers July 17 – 21, 2006
Contents
1 Foreword 1
2 Summary Report 3
3 Agenda 5
4 Participants List ........................................................................................................... 9
5 Lecture Dr. Stephen Mieke
OIML R 16-2 “Non-invasive Sphygmomanometer”
Medical background ................................................................................................ 11
Techniques to measure indirectly the blood pressure.............................................. 13
Requirements, standards, etc for sphygmomanometers .......................................... 16
Requirements for automated sphygmomanometer (pattern approval) .................... 17
Requirements for automated sphygmomanometer (verification) ............................ 26
Difference between OIML R16-2 and EN 1060 ............................................................... 30
Traceability of Medical Device......................................................................................... 33
European standards on sphygmomanometers ................................................................... 36
European simulator to test automated sphygmomanometers
Accuracy requirements ............................................................................................ 51
Why simulators? ...................................................................................................... 52
Design of simulators ................................................................................................ 53
Results from measurements with simulators ........................................................... 60
Outlook .................................................................................................................... 60
Current Situation in Germany for sphygmomanometers .................................................. 62
Mr. Shinichi Bunryou
Type Approval System for sphygmomanometers in legal metrology, Japan
Introduction on measurement law in Japan ............................................................. 67
Why need passing the verification? ......................................................................... 70
How to pass verification and why need type approval ............................................ 71
Automated sphygmomanometers
Introduction.............................................................................................................. 74
Mode for testing....................................................................................................... 76
Mr. Porson Fu
Electronics Testing Center, Taiwan .................................................................................. 78
Dr. Chang-Chyi Lin
NIBP monitor .................................................................................................................... 89
Mr. Chen-Chuan Hung
The Accuracy and Traceability of Non Invasive Automated Sphygmomanometers........ 96
6 Reports from the Trainees
6.1 Cambodia (This is a non-APEC economy.) .......................................................... 103
6.2 Indonesia................................................................................................................ 106
6.3 Malaysia................................................................................................................. 110
6.4 Mongolia (This is a non-APEC economy.) ........................................................... 114
6.5 Papua New Guinea ................................................................................................ 119
6.6 Peru ........................................................................................................................ 122
6.7 Philippines ............................................................................................................. 125
6.8 Chinese Taipei ....................................................................................................... 128
6.9 Viet Nam................................................................................................................ 137
Foreword
This booklet is one of the outcomes of the APEC Seminars and Training Courses in
Legal Metrology titled “Seminar on Automated Sphygmomanometers” which was held on
July 17 – 21, 2006 at the Howard International House in Taipei, Chinese Taipei. This course
was organized as a follow-up of “Seminar on Sphygmomanometers” conducted in August
2004 in Chinese Taipei. This time, we put more focus on the comparison and information
exchange among the participated economies on the current trends of sphygmomanometer’s
metrological standards practiced in the APLMF member economies, while the previous
seminar was aimed at building a fundamental understanding on its international standards.
This seminar was organized by the Asia-Pacific Legal Metrology Forum (APLMF) and
Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs of
Chinese Taipei with a support fund of APEC Trade and Investment Liberalization and
Facilitation (APEC-TILF) program, CTI-11/2006T. It was also supported by: (1) The Center
for Measurement Standards (CMS), The Industrial Technology Research Institute (ITRI); (2)
Electronic Testing Center (ETC), Chinese Taipei; (3) Physikalisch-Technische Bundesanstalt
(PTB), Germany and (4) National Metrology Institute of Japan (NMIJ). Having this result, I
would like to extend my sincere gratitude to Dr. Jay San Chen of BSMI, Dr. Chi-Sheng Chang
of CMS, Mr. David Y. Wang of ETC, Dr. Stephan Mieke of PTB Germany, Mr. Shinichi
Bunryou of NMIJ, Mr. Chen-Chuan Hung of CMS and Dr. Chang-Chyi Lin of Cheng Hsin
Rehabilitation Medical Center. Also, special thanks should be extended to the APEC
Secretariat for their great contributions.
We have conducted the surveys among the APEC member economies concerning
seminar and training programs in legal metrology to find their needs as well as possible
human resource available in the region. The survey shows that there is a strong need for a
training course or seminar on sphygmomanometers in legal metrology. Medical measurement
has become a great interest of the member economies due to the extended average life
expectancy. Plus, medical measuring instruments, such as sphygmomanometers and clinical
thermometers are getting widely used not only in medical facilities but also at home. In
particular, portable measuring devices are expected to be widely used in near future. Where,
there is one big problem concerning the reliability and mutual acceptability of measured
results by such instruments. Now, standards and regulations for such instruments need to
harmonize among APEC economies. However, our survey also shows that there are not
enough human resources for developing economies to ensure reliability on medical
instruments. Such seminar and training course could be effectively carried out under the
arrangements of the international organizations APEC and APLMF.
Main target of this training course was to assist APEC members to develop common
understanding about the current standards and regulations on automated sphygmomanometers
1
and thus meet the APEC objective to harmonize metrology legislation with OIML
international recommendations. The actual contents of the seminar were focused on learning
different approaches used in other economies concerning the standards and regulations on
sphygmomanometers.
In view of these situations, the seminar on automated sphygmomanometers provides
opportunity to the Asia-Pacific region for a sure basis of confidence in Legal Metrology
related to medical measurements. I would say certainly that this is a valuable starting step to
fruitful activities of medical measurements in the Asia-Pacific region.
I am really pleased to have this outcome from the training course and again deeply
appreciate invaluable voluntary efforts of the APEC and APLMF secretariats.
February 27, 2007
Dr. Akira Ooiwa
APLMF President
2
Summary Report on theSeminar on Non-invasive Automated Sphygmomanometers
Chinese Taipei conducted a survey on non-invasive automated sphygmomanometers in 2003
then hosted a seminar on non-invasive automated sphygmomanometers in late August 2004
according to the result of the survey. The seminar was supported by APEC and APLMF. NMIJ also
gave very helpful support. All participants satisfied with the results. Therefore, APLMF asked the
Bureau of Standards, Metrology and Inspection (BSMI), Chinese Taipei organizes another seminar
on non-invasive automated sphygmomanometers from July 17 to 21in 2006. As usual, BSMI
worked with APLMF Secretariat closely to make sure the seminar would reach its original goal.
Eight participants from Cambodia, Indonesia, Malaysia, Mongolia, Papua New Guinea, Peru,
Philippines and Viet Nam participated with support either from APEC or APLMF, and sixteen
participants from the host economy attended the seminar. All of them benefited a great deal from
three prominent speakers in the field of the legal control issues in sphygmomanometers at the
seminar, i.e. Dr. Stephan Mieke, Head of Working Group of Standards for Medical Measuring
Techniques, PTB, Germany and the Secretariat of TC18: Medical measuring instruments, OIML;
Mr. Shin- Bunryou, a senior expert of NMIJ, Japan; and Mr. Chen-Chuan Hung, Researcher,
National Measurement Laboratory. Dr. Mieke lectured on OIML Recommendation 16-2 and the
difference between OIML R 16-2 and EN 1060. He also talked about the European Standards of
sphygmomanometers and current situation in Germany and also brought the concept of sort
traceability. Mr. Bunryou introduced the relative regulations in Japan and shared his experience in
the field of type approval of sphygmomanometers in the three- hour presentation. Mr. Hung briefed
the relative regulation in Chinese Taipei. In addition, Dr. Chang-Chyi Lin, a physician of Cheng
Hsin Rehabilitation Medical Center in Taipei, presented the concept of the application of
sphygmomanometers in clinical practice.
Three technical trips were arranged. The first trip was a visit to Electronics Testing Centre on
20th. Mr. Wang, the president of the centre, received all participants and expressed his welcome.
His staffs let us observe their testing equipments for sphygmomanometers as well as the testing
procedures for sphygmomanometers. They also answered the questions from participants. During
the demonstration, Dr. Mieke gave a lot of useful comments to help participants understand the
whole picture of the testing process. The second trip was a visit to the National Measurement
Laboratory in Hsin-Chu. The scientists and engineers in the lab introduced the national
measurement standards. On the following day, July 21st, all participants visited the 7th Division of
BSMI. Mr. Chang, the director of the division, briefed the main tasks of his office, and the
engineers demonstrated the procedures of verification for measurement instruments.
One of the most important objectives of the seminar was to establish friendship among
participants from different countries working in this field. To achieve this objective, a welcome
party was held at Howard Skyline Restaurant Taipei on the night of July 17. Looking through
windows from the 44th floor where the restaurant is located, everyone enjoyed watching the
amazing scenery of Taipei and took a lot of pictures. Certainly, all participants experienced
delicious cuisine at this restaurant. Participants also visited a traditional Hakka restaurant in Hsin-
3
Chu before the trip to NML. Hakka society, basically emigrated from Southern Mainland China
during Chin Dynasty to the island, is one of the main groups of Taiwanese society. This restaurant
is famous for its architecture, garden and delicious dishes. It is a great place to learn about the
history in the fancy true Hakka culture. A farewell dinner was held at the Caesar Park Hotel on the
night of July 20th. In addition, all the participants visited Taipei 101, the tallest building in the
world, and went up to Observation Station at the 89th floor to overlook Taipei City.
This seminar enhanced participants’ understanding of OIML R 16-2 and other related standards,
which certainly helped achieve the objective of APLMF to harmonize metrological standards
among member economies and remove technical barriers to trade. We believe that the holding of
such seminars is an effective method to promote APLMF goals, from which all member economies
would benefit.
During the seminar, all participants presented the current legislations and controls of non-
invasive automated sphygmomanometers in his/her country. The presentations have been posted on
the APLMF website at http://www.aplmf.org/training_courses/index.htm.
Dr. Jay-San Chen Director General Bureau of Standards, Metrology and Inspection
4
APEC/APLMF Seminars and Training Courses in Legal Metrology (CTI–11/2006T)
Seminar on Automated Sphygmomanometers
July 17 – 21, 2006 at the Howard International House in Taipei, Chinese Taipei
Program
Organizers:1. Asia–Pacific Economic Cooperation (APEC)
2. Asia–Pacific Legal Metrology Forum (APLMF)
3. Bureau of Standards, Metrology and Inspection (BSMI),
Ministry of Economic Affairs (M.O.E.A.)
Supporting Organizations:
1. The Center for Measurement Standards (CMS),
The Industrial Technology Research Institute (ITRI)
2. Electronic Testing Center (ETC), Chinese Taipei
3. Physikalisch-Technische Bundesanstalt (PTB), Germany
4. National Metrology Institute of Japan (NMIJ),
National Institute of Advanced Industrial Science and Technology (AIST)
Main Objective of the Seminar:
Some portable medical measuring instruments, such as clinical electrical thermometers and
automated sphygmomanometers are getting to be widely used not only in medical facilities but also
in private homes. However, there remain problems concerning the reliability and mutual
acceptability of measured results by such instruments. Standards and regulations for such
instruments are just starting to be under operation.
Main target of this seminar is to assist APEC and APLMF member economies to develop
common understanding about the current standards and regulations on automated
sphygmomanometers and thus meet the APEC objective to harmonize metrology legislation with
OIML international recommendations. Officials in charge of type approvals and/or regulation of
automated sphygmomanometers are expected to attend the seminar. Actual contents of the lecture
would be focused on the understanding of basic construction of automated sphygmomanometers
and current international or national standards and regulations related to the sphygmomanometers.
Asia–Pacific Legal Metrology Forum
Bureau of Standards, Metrology and Inspection
5
Venue and Accommodation:
Howard International House Taipei
30 HsinSeng South Road, Section 3, Taipei 106, Chinese Taipei,
Telephone: (886-2) 8369-1155
Fax: (886-2) 8369-1177
http://3w.howard-hotels.com.tw/
Accommodations:
Accommodation for the participants will be prepared in the Howard International House on a
request from the participant at a rate of NT$1700 (about US$50). Please use the separated
registration form to reserve the accommodations.
Speakers:
Dr. Stephan Mieke, Head, Standards for Medical Metrology, PTB
Mr. Shinichi Bunryo, Dissemination Technology Division, NMIJ, AIST
Mr. Chen-Chuan Hung, Measurement Standards & Technology Division, CMS, ITRI
Dr. Chang-Chyi Lin, Cheng Hsin Rehabilitation Medical Center
Registration:
Fill the attached “Registration Form” and send it to the APLMF secretariat by June 23, 2006.
Passport, Visa and Vaccinations:
Every participant will be required to hold a valid passport and valid visa for entry into Chinese
Taipei. Some foreign nationals are granted an automatic visa upon arrival. Please check with
your local Trade and Culture Office of Chinese Taipei regarding visas and vaccinations.
If you find out that you need visa, please fill the attached “Visa Assistance Form” and send it to
the host (BSMI) by July 7, 2006. On your request, the host will send an official ‘letter of
invitation’ to participants for visa application at the Trade and Cultural Offices of Chinese Taipei
in the participants’ countries.
For more information, please visit the Ministry of Foreign Affair’s web-site at
http://www.mofa.gov.tw/mofa91/web/welcome.html or the Bureau of Consular Affair’s web-site
at http://www.boca.gov.tw/english/index.htm.
Access Information:
Howard International House Taipei is about 45 kilometres from Chiang Kai-Shek
International Airport. We recommend you to take the “Air Bus” that runs every 30 minutes, and
it would take about 70 minutes to get to from CKS Airport to downtown Taipei, at a costs of
NT$140. You should get off at the Howard Hotel, and ask the front desk to arrange a taxi to the
Howard International House Taipei ( , 3 30 ) cost about
NT$150.
Taxis are convenient and relatively inexpensive. However, most taxi drivers in Taipei do no
speak English. It is most helpful to have your intended locations written in Chinese for the driver.
6
Currency and Credit Cards:
The currency in Chinese Taipei is New Taiwan Dollars. Coin denominations are NT$1, NT$5,
NT$10, NT$20, and NT$50. Bill denominations are NT$100, NT$200, NT$500, NT$1000, and
NT$2000. The current exchange rate for NT dollar is about US$1= NT$32.5. Foreign currency and
traveler’s checks can be exchanged at most banks. International credit cards such as VISA,
American Express, Diner Club or Master Card are accepted in most hotels, restaurants, department
stores, and shops.
Climate and Clothing:
The weather in Taipei in July is very hot. The average temperature is about 31 degree Centigrade.
Please log on the website of the Central Weather Bureau (http://www.cwb.gov.tw/V5e/index.htm)
for your information.
Electricity Supply:
The Electricity supply in Chinese Taipei is 110 V/60 Hz. In some cases, 220 V/60 Hz might also be
available. Always check the power supply if you have any questions.
Local Time:
Local time in Chinese Taipei is GMT+ 8hrs.
Contact Persons about the Seminar:
APLMF Secretariat (registration and travel support)
Tsuyoshi Matsumoto & Ayako Murata
APLMF Executive Secretary
NMIJ/AIST Tsukuba Central 3-9, 1-1-1 Umezono, Tsukuba, Ibaraki 305-8563, Japan
Tel: +81-298-61-4362
Fax: +81-298-61-4393
E-mail: [email protected] & [email protected]
Host in Chinese Taipei (visa assistance, accommodation, venue and access information)
Ms. Meggie Chu
Bureau of Standards, Metrology and Inspection (BSMI),
Ministry of Economic Affairs (M.O.E.A.)
7F, No.20, Nanhai Road, Taipei 100, Chinese Taipei
Tel: + 886-2-2396-3360 ext 738
Fax: + 886-2-2343-1976
E-mail: [email protected]
7
Final Program 08:30–09:00 Registration
09:00–09:15Opening ceremony Welcoming address (Dr. Jay-San Chen, Director General of BSMI)* Opening address (Dr. Matsumoto, APLMF Executive Secretary)
09:15-09:20 Taking a group picture 09:20-10:00 Coffee break and a press conference
10:00–12:00OIML R 16-2 “Non-Invasive Sphygmomanometer” (Dr. Mieke) (1) Medical background / (2) Techniques to measure indirectly the blood pressure
12:00–13:30 Lunch break
13:30–15:20 (3) Requirements, standards etc. for sphygmomanometer / The traceability on automated sphygmomanometer (Dr. Mieke)
15:20–15:40 Coffee break 15:40–17:00 (4) Requirements for automated sphygmomanometer (pattern approval) (Dr. Mieke)
18:00 Leave hotel lobby for the dinner by bus
July 17 Monday
(Room 101)
18:30–21:00 Welcome dinner hosted by the BSMI at the Howard Skyline Restaurants Taipei, 66 Chunghsiao W. Rd., Sec. 1, 44/45F, Taipei
09:00–10:20 (4) Requirements for automated sphygmomanometer (pattern approval) (Dr. Mieke) 10:20–10:40 Coffee break 10:40–12:00 (5) Requirements for automated sphygmomanometer (verification) (Dr. Mieke) 12:00–13:30 Lunch break
13:30–15:20 (6) Difference between OIML R16-2 and EN 1060 (Dr. Mieke) (7) European standards on sphygmomanometers (Dr. Mieke)
15:20–15:40 Coffee break
July 18 Tuesday
(Room 101)
15:40–17:00 (8) European simulator to test automated sphygmomanometers (Dr. Mieke)
09:00–10:20 Clinical application of blood pressure measurement (Dr. Lin)
10:20–10:40 Coffee break
10:40–12:00 (9) Current situation in Germany on sphygmomanometers (Dr. Mieke)
12:00–13:30 Lunch break
13:30–15:20 Type approval system for Sphygmomanometers in Japan (Mr. Bunryo)
15:20–15:40 Coffee Break
July 19 Wednesday
(Room 101)
15:40–17:00 Type approval system for Sphygmomanometers in Japan (Mr. Bunryo)
08:30 Leave hotel lobby for the technical visit by bus
09:30–11:00 Technical visit to Electronic Testing Center (ETC) in Taoyuan (Mr. David Wang, Mr. Shih-Ming Chang (ETC) & host staffs)
12:00–13:30 Lunch break at a restaurant in Golden Mountain Fine Arts & Life Style in Hsinchu
13:45–16:00 Technical visit to Measurement Standards & Technology Division, CMS, ITRI in Hsinchu (Dr. Chi-Sheng Chang, Mr. Chen-Chuan Hung (CMS) & host staffs)
17:20-18:15 After going back to the hotel, visit the Chiang Kai-shek Memorial Hall
July 20 Thursday
(ETC & CMS/ITRI)
18:30–21:00 Farewell dinner hosted by the BSMI at the Hotel Caesar Park Taipei, 38 Chung Hsiao W. Rd., Sec. 1, Taipei
8:30 Leave for the Headquarters of BSMI at 4 Sec. 1, Chinan Road, Taipei by bus 09:00–10:00 Summary including country report by a trainee from each economy (all participants) 10:00–10:25 Coffee break
10:25–12:10
Continue the presentation (all participants) Presentation of certificates to all participants (Dr. Matsumoto, Mr. Shu & Ms. Chu) Closing ceremony (Mr. Brian Shu & Dr. Matsumoto) Take a group photo at the front entrance of headquarters, BSMI (all participants)
12:10–13:30 Lunch break at the restaurant How-Tsu-Do Fon-Wui-Guang near BSIM (host staffs)
July 21 Friday
(BSMI & Taipei city)
14:00–17:30 Technical visit to the 7th Division of BSMI, No. 78, Sec. 5, Cheng-de Road, Shih-lin District, Taipei (Mr. Cheng-Chih Chang & host staffs) / Visit Taipei 101 (host staffs)
*Persons in ( ) are the speakers or instructors.
8
Participants List of Seminar on Automated SphygmomanometersJuly 17 – 21, 2006 at the Howard International House in Taipei, Chinese Taipei
No. Category Economy Name Organization
1 Speaker Germany Dr. Stephan MiekeHead, Standards for Medical Metrology,Physikalisch-Technische Bundesanstalt (PTB)
2 Speaker Japan Mr. Shinichi BunryouResearch Scientist, Pattern Approval Section, Dissemination TechnologyDivision, National Metrology Institute of Japan, AIST
3 Speaker Chinese Taipei Mr. Chen-Chuan HungResearcher, Mechanical Measurement Laboratory, Measurement Standards &Technology Division, Center for Measurement Standards (CMS),Industrial Technology Research Institute (ITRI)
4 Speaker Chinese Taipei Dr. Chang-Chyi Lin Cheng Hsin Rehabilitation Medical Center
5 APLMF Japan Dr. Tsuyoshi Matsumoto National Metrology Institute of Japan, AIST
6 WG/Host Chinese Taipei Dr. Chi-Sheng ChangCenter for Measurement Standards (CMS),Industrial Technology Research Institute (ITRI)
7 WG/Host Chinese Taipei Mr. Cheng-Chih ChangBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
8 WG/Host Chinese Taipei Mr. Shih-Ming Chang Electronics Testing Center, Taiwan.
9 WG/Host Chinese Taipei Dr. Jay-San ChenBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
10 WG/Host Chinese Taipei Mr. Wu-Hsiung ChenBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
11 WG/Host Chinese Taipei Mr. Henry Cheng Electronics Testing Center, Taiwan.
12 WG/Host Chinese Taipei Ms. Meggie ChuBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
13 WG/Host Chinese Taipei Mr. Lai-Ho HuangBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
14 WG/Host Chinese Taipei Ms. Yuh-Guang JinBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
15 WG/Host Chinese Taipei Mr. David Y. Wang President, Electronics Testing Center, Taiwan.
16 WG/Host Chinese Taipei Mr. Jin-Hai YangBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
17 Trainee Cambodia Mr. Kim Chandara Department of Metrology, Ministry of Industry, Mines and Energy
18 Trainee Indonesia Mr. Nino Wawan SetiawanDirectorate of Metrology, General Directorate of Domestic Trade,Ministry of Trade of Republic Indonesia
19 Trainee Malaysia Ms. Hairani Binti NordinNational Metrology Laboratory, SIRIM Berhad(NML-SIRIM)
20 Trainee Mongolia Mr. Dashrenchin Bayasgalan Mongolian Agency for standardization and Metrology
21 Trainee Papua New Guinea Mr. Reuben Koi Harokave National Institute of Standards and Industrial Technology
22 Trainee Peru Mr. Leonardo De La CruzNational Institute for the Defense of Competition and Protection of IntellectualProperty
23 Trainee Philippines Mr. Radley Flores ManaloNational Metrology Laboratory,Industrial Technology Development Institute (ITDI)
9
24 Trainee Viet Nam Mr. Bui Trung Dung Metrology Department, Directorate for Standards and Quality-STAMEQ
25 Trainee Chinese Taipei Mr. Chen Horng-LinBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
26 Trainee Chinese Taipei Ms. Jennifer Chu Rossmax International Ltd.
27 Trainee Chinese Taipei Mr. Bo-Sen Fu Electronics Testing Center, Taiwan.
28 Trainee Chinese Taipei Mr. Chen-Chuan Hung Measurement Standards & Technology Division, CMS, ITRI
29 Trainee Chinese Taipei Mr. Fu-Chang KungBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
30 Trainee Chinese Taipei Mr. Alex Kou HEALTH & LIFE CO. , LTD
31 Trainee Chinese Taipei Mr. Chen Cheng KuoBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
32 Trainee Chinese Taipei Mr. Ching-Chia LaiBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
33 Trainee Chinese Taipei Mr. Alan Lee Mars Metal Co. , Ltd.
34 Trainee Chinese Taipei Mr. Wen Lang LinBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
35 Trainee Chinese Taipei Mr. Chun Pin LiuBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
36 Trainee Chinese Taipei Mr. Wen Pin TsaiBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
37 Trainee Chinese Taipei Ms. Ariel Wang Microlife Corporation
38 Trainee Chinese Taipei Ms. Sammi ChungBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
39 Trainee Chinese Taipei Mr. Brian C.S. ShuBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
40 Trainee Chinese Taipei Ms. Pei-Ping WangBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
41 Trainee Chinese Taipei Mr. Te-Shuen WangBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
42 Trainee Chinese Taipei Mr. Jenn-Chyi YangBureau of Standards, Metrology and Inspection (BSMI),Ministry of Economic Affairs
*Names are listed in alphabetical order of their categories, economies and last names.
10
AP
EC
/AP
LM
F T
rain
ing
Cou
rses
in L
egal
Met
rolo
gy
(CT
I-11
/200
6T)
Sem
inar
on
Aut
omat
ed S
phyg
mom
anom
eter
s
OIM
L R
16-
2 “N
on-i
nvas
ive
Sphy
gmom
anom
eter
”
Step
han
Mie
kePh
ysik
alis
ch-T
echn
isch
e B
unde
sans
talt
Ber
lin
Ove
rvie
w:
•M
edic
al b
ackg
roun
d
•T
echn
ique
s to
mea
sure
indi
rect
ly th
e bl
ood
pres
sure
•R
equi
rem
ents
, Sta
ndar
ds e
tc. f
or s
phyg
mom
anom
eter
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(pa
ttern
app
rova
l)
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(ve
rifi
catio
n)
Ove
rvie
w:
•M
edic
al b
ackg
roun
d
•T
echn
ique
s to
mea
sure
indi
rect
ly th
e bl
ood
pres
sure
•R
equi
rem
ents
, Sta
ndar
ds e
tc. f
or s
phyg
mom
anom
eter
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(pa
ttern
app
rova
l)
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(ve
rifi
catio
n)R
ight
:Sc
ipio
neR
iva-
Roc
cigr
adua
ted
in m
edic
ine
and
surg
ery
in 1
888
from
the
Uni
vers
ity o
f T
orin
ow
ith th
e m
edic
al d
octo
rate
.
Lef
t: A
n ea
rly
sphy
gmom
anom
eter
des
igne
d on
Riv
a-R
occi
‘sid
eas.
1896
11
Rig
ht:N
ikol
ai S
erge
evic
hK
orot
koff
pres
ente
d a
repo
rt o
n a
new
met
hod
of m
easu
rem
ent o
f ar
teri
al
pres
sure
on
Nov
embe
r 8,
190
5, a
t a s
cien
tific
sem
inar
of
the
Impe
rial
Mili
tary
Med
ical
Aca
dem
y,
Sain
t Pet
ers-
burg
, Rus
sia.
Lef
t: T
he R
iva-
Roc
cisp
hygm
oman
omet
er h
e w
as u
sing
for
his
thes
is (
the
stet
hosc
ope
is n
ot s
how
n).
1905
The
hea
rt a
s a
pum
p
Man
's b
iolo
gica
l fun
ctio
ns a
re m
aint
aine
d by
the
circ
ulat
ion
of th
e bl
ood
thro
ugh
the
hum
an b
ody.
Thi
s tr
ansp
ort s
yste
m p
erfo
rms
man
y fu
nctio
ns; f
or e
xam
ple,
oxy
gen
and
nutr
ient
s ar
e su
pplie
d to
the
cells
an
d ca
rbon
dio
xide
and
met
abol
ic p
rodu
cts
carr
ied
away
. The
blo
od a
nd it
s co
nstit
uent
s ha
ve m
any
othe
r fu
nctio
ns, e
.g. t
he d
efen
ce a
gain
st e
xoge
nic
subs
tanc
es p
enet
ratin
g th
e bo
dy.
The
blo
od is
con
stan
tly c
ircu
latin
g th
roug
h m
an's
art
eria
l and
ven
ous
syst
em. T
his
flow
of
bloo
d to
all
part
sof
the
body
is m
aint
aine
d by
two
pum
ps, t
he le
ft s
ide
and
the
righ
t sid
e of
the
hear
t.
The
left
sid
e of
the
hear
t pum
ps th
e bl
ood
oxyg
enat
ed in
the
lung
s in
to th
e ar
teri
al s
yste
m, t
hus
supp
lyin
g bl
ood
to th
e m
uscl
es, o
rgan
s an
d ot
her
cells
. The
blo
od p
asse
s fr
om th
e lu
ngs
thro
ugh
the
left
aur
icle
, the
aor
ta
and
the
arte
ries
to e
ver
smal
ler
vess
els
whi
ch u
ltim
atel
y en
d at
the
cells
in a
larg
e nu
mbe
r of
art
erio
les
and
capi
llari
es.
In c
ontr
ast t
o th
is, t
he r
ight
sid
e of
the
hear
t pum
ps th
e bl
ood,
in w
hich
car
bon
diox
ide
has
been
abs
orbe
d,
from
the
veno
us s
yste
m in
to th
e lu
ngs
to m
ake
gase
ous
inte
rcha
nge
poss
ible
. The
blo
od in
the
num
erou
s sm
all
vein
s ta
kes
up th
e m
etab
olic
pro
duct
s of
the
cells
and
car
ries
thes
e to
the
orga
ns o
f ex
cret
ion.
Car
bon
diox
ide
is
brea
thed
out
in th
e lu
ngs.
Thr
ough
the
veno
us s
yste
m a
nd th
e ri
ght s
ide
of th
e he
art,
the
bloo
d fl
ows
into
the
lung
s.
The
pum
ping
of
the
left
sid
e of
the
hear
t lea
ds to
blo
od p
ress
ure
fluc
tuat
ions
in th
e ar
teri
al s
yste
m. T
he c
ontr
actio
n of
the
card
iac
mus
cle
(sys
tole
) re
sults
in a
str
ong
expu
lsio
n of
bloo
d an
d a
som
ewha
t del
ayed
pre
ssur
e in
crea
se in
th
e ao
rta.
The
pre
ssur
e in
crea
se p
asse
s th
roug
h a
max
imum
whi
le th
e ex
puls
ion
of b
lood
dec
reas
es a
gain
. Dur
ing
the
rela
xatio
n ph
ase
of th
e he
art m
uscl
e (d
iast
ole)
, the
left
hea
rt v
alve
clo
ses.
Alth
ough
blo
od is
no
long
er e
xpel
led,
th
e bl
ood
pres
sure
in th
e ao
rta
does
by
no m
eans
dro
p to
zer
o bu
t con
tinue
s to
dec
reas
e sl
owly
unt
il it
rise
s ag
ain
as
a re
sult
of th
e ne
xt s
ysto
le. T
his
effe
ct is
a c
onse
quen
ce o
f th
e ve
ssel
's e
last
icity
and
per
iphe
ral r
esis
tanc
e.
Fig:
Inv
asiv
e bl
ood
pres
sure
over
tim
e
12
Cla
ssif
icat
ion
of b
lood
pre
ssur
e va
lues
On
the
basi
s of
the
bloo
d pr
essu
re v
alue
s , a
dis
tinct
ion
is m
ade
betw
een
men
with
low
,
norm
al a
nd h
igh
bloo
d pr
essu
re (
hypo
toni
cs, n
orm
oton
ics,
hyp
erto
nics
):
Lim
iting
val
ues
of th
e bl
ood
pres
sure
in th
e st
ate
of r
est
Hyp
oten
sion
:P sy
s<
100
mm
Hg,
Pdi
a<
60
mm
Hg
Hyp
erte
nsio
n:P sy
s>
160
mm
Hg,
Pdi
a>
95
mm
Hg
P sys:
sys
tolic
blo
od p
ress
ure,
Pdi
a:
dias
tolic
blo
od p
ress
ure
Hyp
erte
nsio
n a
glob
al c
halle
nge
Rec
ent a
naly
sis
show
that
as
of 2
000
ther
e ar
e 97
2 m
illio
n pe
ople
livi
ng w
ith h
yper
tens
ion
wor
ldw
ide
and
it is
est
imat
ed th
at th
is n
umbe
r w
ill e
scal
ate
to m
ore
than
1.5
bill
ion
in 2
025
(Kea
rney
PM
et a
l. L
obal
burd
onof
hyp
erte
nsio
n: a
naly
sis
of w
orld
wid
e da
ta. L
ance
t 200
5; 2
65:
217-
23).
Wor
ld H
yper
tens
ion
Lea
gue
(WH
L)
-N
ewsl
ette
r, N
o. 1
07, J
une
2006
, Edi
tori
al b
y A
run
Cho
ckal
inga
m, C
anad
a:A
lthou
gh m
easu
rem
ent o
f bl
ood
pres
sure
is a
sim
ple
proc
edur
e it
is n
ot
done
pro
perl
y by
hea
lth c
are
prof
essi
onal
sal
l aro
und
the
wor
ld. .
.. m
ore
than
50%
of
the
hype
rten
sive
pop
ulat
ion
are
unaw
are
of th
eir
cond
ition
; of
thos
ew
ho a
re a
war
e m
ore
than
50%
hav
e
not b
een
trea
ted.
WH
O R
epor
t: R
educ
ing
risk
s, p
rom
otin
g he
alth
y lif
e, G
enev
a 20
02
(http
://w
ww
.who
.int/w
hr/2
002/
en):
Rai
sed
bloo
d pr
essu
re is
alm
ost a
lway
s w
ithou
t sym
ptom
s. H
owev
er,e
leva
ted
bloo
d pr
essu
re le
vels
prod
uce
a va
riet
y of
str
uctu
ral c
hang
es in
the
arte
ries
that
sup
ply
bloo
d to
the
brai
n, h
eart
, kid
neys
and
else
whe
re. I
n re
cent
dec
ades
it h
as b
ecom
e in
crea
sing
ly c
lear
that
the
risk
s of
str
oke,
isch
aem
ic
hear
t dis
ease
, ren
al f
ailu
re a
nd o
ther
dis
ease
...
Glo
bally
, the
se a
naly
ses
indi
cate
that
abo
ut 6
2% o
f ce
rebr
ovas
cula
rdi
seas
e an
d 49
% o
f is
chae
mic
hear
t dis
ease
are
attr
ibut
able
to s
ubop
timal
blo
od p
ress
ure
(sys
tolic
>11
5 m
mH
g), w
ith li
ttle
vari
atio
n by
sex
.
DA
LY
(di
sabi
lity-
adju
sted
life
yea
r) –
one
DA
LY
bei
ng e
qual
to th
e lo
ss o
f on
e he
alth
y lif
e ye
ar
Mea
n ar
teri
al p
ress
ure
An
addi
tiona
l val
ue is
oft
en s
tate
d, i.
e. th
e m
ean
arte
rial
pre
ssur
e (M
AP)
, whi
ch
can
be d
eter
min
ed b
y va
riou
s m
etho
ds. T
he d
efin
ition
is g
iven
by
the
inte
gral
of
the
bloo
d pr
essu
re c
urve
rel
ated
to o
ne h
eart
bea
t. Si
nce
the
con
tinua
l
dete
rmin
atio
n of
the
bloo
d pr
essu
re c
urve
is p
ossi
ble
only
by
inva
sive
met
hods
and
by o
nly
few
non
-inv
asiv
e m
etho
ds, d
iffe
rent
app
roxi
mat
ion
met
hods
exi
st.
The
app
roxi
mat
ion
mos
t fre
quen
tly a
pplie
d is
as
follo
ws:
P MA
P=
Pdi
a+
1/3
(P s
ys-
P dia)
P MA
P:
mea
n ar
teri
al p
ress
ure
Sphy
gmom
anom
eter
s ap
plyi
ng th
e os
cillo
met
ric
met
hod
usua
lly in
dica
te th
e
osci
llatio
n m
axim
um a
s m
ean
arte
rial
pres
sure
.
13
Site
s of
blo
od p
ress
ure
mea
sure
men
t
The
upp
er p
art o
f th
e ar
m is
nor
mal
ly u
sed
for
non-
inva
sive
blo
od p
ress
ure
mea
sure
men
t. T
here
is o
nly
one
larg
er a
rter
y in
the
uppe
r ar
m, t
he a
rter
iabr
achi
alis
, whi
ch c
onve
ys b
lood
to th
e lo
wer
arm
and
the
hand
.
The
adv
anta
ges
of th
is p
lace
of
mea
sure
men
t are
as
follo
ws:
-th
e m
easu
rem
ent i
s ta
ken
at n
ot to
o gr
eat a
dis
tanc
e fr
om th
e he
art,
-th
e in
flue
nce
of th
e pe
riph
ery
is n
ot y
et im
port
ant,
-th
e m
easu
rem
ent i
s ta
ken
at h
eart
leve
l (w
ith th
e ar
m in
nor
mal
pos
ition
).
Ano
ther
site
of
bloo
d pr
essu
re m
easu
rem
ent i
s th
e th
igh.
The
dis
adva
ntag
es a
s co
mpa
red
with
the
uppe
r
arm
are
abo
ve a
ll th
e gr
eate
r di
stan
ce f
rom
the
hear
t and
the
nece
ssity
to ta
ke th
e m
easu
rem
ent w
ith th
e
patie
nt ly
ing
to a
void
hyd
rost
atic
eff
ects
, i.e
. to
mea
sure
at h
eart
leve
l.
Esp
ecia
lly f
or h
ome-
use
devi
ces
the
mea
sure
men
t at t
he w
rist
has
bec
ome
very
pop
ular
in th
e pa
st 1
0
year
s.T
his
site
can
be
used
onl
y by
aut
omat
ed o
scill
omet
ric
devi
ces.
As
for
the
thig
h, it
is n
eces
sary
to
avoi
d th
ehy
dros
tatic
eff
ect (
5 cm
mis
plac
emen
t in
heig
ht y
ield
an
erro
r of
ca.
4 m
mH
g). C
linic
al
eval
uatio
ns h
ave
show
n, th
at m
ost d
evic
es a
re le
ss a
ccur
ate,
than
upp
er a
rm d
evic
es.
Upp
er p
art:
Cuf
f pr
essu
re d
ecay
ove
r tim
e
Low
er p
art:
Aco
ustic
sig
nal (
Kor
otko
ffso
und)
over
tim
e;th
e be
gin
and
end
of th
e K
orot
koff
soun
d ar
e m
arke
r fo
r th
e sy
stol
ic (
SYS)
and
dias
tolic
(D
IA)
bloo
d pr
essu
re
The
Kor
otko
ffm
etho
d
The
non
-inv
asiv
e m
etho
d de
velo
ped
in 1
905
by N
ikol
ai S
erge
jevi
tch
Kor
otko
ff, a
Rus
sian
doc
tor,
use
s a
cuff
and
a st
etho
scop
e. T
he m
easu
rem
ent i
s us
ually
car
ried
out
on
the
uppe
r ar
m, b
ut m
easu
rem
ent o
n th
e th
igh
is a
lso
feas
ible
.
Firs
t the
cuf
f on
the
uppe
r ar
m is
infl
ated
to a
pre
ssur
e va
lue
high
er th
an th
e ex
pect
ed s
ysto
lic b
lood
pre
ssur
e,
so th
at th
e bl
ood
stop
s fl
owin
g th
roug
h th
e ar
teri
es b
eyon
d th
e cu
ff. T
he s
teth
osco
pe is
pla
ced
belo
w th
e cu
ff,
abov
e th
e ar
teri
abr
achi
alis
. Air
fro
m th
e cu
ff is
then
slo
wly
rel
ease
d by
ope
ning
of
the
valv
e so
that
the
cuff
pres
sure
dro
ps s
low
ly. W
hile
the
pres
sure
in th
e cu
ff is
red
uced
, sou
nds
can
be h
eard
with
the
stet
hosc
ope.
The
sou
nds
nam
ed a
fter
Kor
otko
fffo
llow
the
rhyt
hm o
f th
e he
art b
eats
. Whe
n th
e K
orot
koff
soun
ds a
re h
eard
for
the
firs
t tim
e, th
e m
anom
eter
is r
ead
and
the
valu
e ta
ken
as s
ysto
lic b
lood
pre
ssur
e va
lue.
With
the
cuff
pre
ssur
e
falli
ng, t
he s
ound
s ch
ange
in to
ne c
olou
r an
d ul
timat
ely
fade
out
com
plet
ely;
at t
his
mom
ent t
he d
octo
r re
ads
the
cuff
pre
ssur
e on
ce a
gain
and
take
s it
as d
iast
olic
blo
od p
ress
ure
valu
e.
Cla
ssif
icat
ion
of th
e K
orot
koff
soun
ds in
to p
hase
s
Phas
e I:
T
he p
erio
d m
arke
d by
the
firs
t app
eara
nce
of f
aint
, cle
ar tr
appi
ng s
ound
s w
hich
gra
dual
ly in
crea
se
in in
tens
ity.
Phas
e II
: T
he p
erio
d du
ring
whi
ch a
mur
mur
or
swis
hing
qua
lity
is h
eard
.
Phas
e II
I: T
he p
erio
d du
ring
whi
ch s
ound
s ar
e cr
ispe
r an
d in
crea
se in
inte
nsity
.
Phas
e IV
: The
per
iod
mar
ked
by th
e di
stin
ct, a
brup
t muf
flin
g of
sou
nd s
o th
at a
sof
t, bl
owin
g qu
ality
is h
eard
.
Phas
e V
: T
he p
oint
at w
hich
sou
nds
disa
ppea
r.
Opt
imal
def
lati
on r
ate
The
def
latio
n ra
te is
one
of
the
mos
t im
port
ant f
acto
rs f
or th
e ac
cura
cy o
f th
e K
orot
koff
met
hod.
The
det
erm
inat
ion
of th
e sy
stol
ic a
nd d
iast
olic
blo
od p
ress
ure
is b
ased
on
the
audi
ble
soun
ds. T
he
firs
t Kor
otko
ffso
und
will
be
audi
ble,
whe
n th
e bl
ood
pres
sure
is ju
st a
littl
ebi
t hig
her,
than
the
cuff
pre
ssur
e af
fect
ing
the
arte
ry. I
f th
e de
flat
ion
rate
is v
ery
high
(>
3 m
mH
g/s)
this
fir
st m
omen
t
will
be
dete
cted
less
acc
urat
e.T
hem
axim
um e
rror
is d
irec
tly p
ropo
rtio
nal t
o th
e de
flat
ion
rate
.
As
a co
nseq
uenc
e on
e w
ould
sug
gest
ver
y lo
w d
efla
tion
rate
s, m
inim
izin
g th
is e
rror
, unf
ortu
nate
ly
it yi
elds
ano
ther
pro
blem
. Low
def
latio
n ra
tes
(<
2m
mH
g/s)
res
ult i
n a
long
last
ing
mea
sure
men
t
and
an in
crea
se o
f bl
ood
in th
e do
wne
r ar
m. T
he b
lood
is 't
rapp
ed' i
n th
e do
wne
r ar
m b
ecau
se th
e
veno
us p
ress
ure
is to
o lo
w (
<30
mm
Hg)
to p
ass
the
cuff
and
to f
low
bac
k to
the
righ
t hea
rt. S
ince
this
is a
n ex
trao
rdin
ary
phys
iolo
gica
l sta
te th
e 'tr
ue' b
lood
pre
ssur
e in
the
arm
is in
crea
sing
, i.e
. the
bloo
d pr
essu
re b
ecom
es d
iffe
rent
fro
m th
e re
al o
ne.
The
sam
e ex
plan
atio
n ap
plie
d fo
r th
e de
term
inat
ion
of th
e di
asto
lic p
ress
ure.
As
a co
mpr
omis
e de
flat
ion
rate
s of
2-3
mm
Hg/
s ar
e su
gges
ted
to g
et th
e be
st r
esul
ts.
14
Cuf
f
The
cuf
f co
nsis
ts o
f a
fabr
ic o
r sy
nthe
tic s
leev
e en
clos
ing
a bl
adde
r. D
ispo
sabl
e cu
ffs,
esp
ecia
lly th
ose
for
new
born
chi
ldre
n (n
eona
tes)
are
oft
en m
anuf
actu
red
of w
elde
dsy
nthe
tic m
ater
ial w
ith in
tegr
ated
bl
adde
r.
Sinc
e th
e cu
ff p
ress
ure
dire
ctly
infl
uenc
es th
e bl
ood
flow
thro
ugh
the
arte
ria
brac
hial
isor
oth
er a
rter
ies
-tis
sue,
mus
cles
and
bone
s m
ay b
e co
nsid
ered
as
alm
ost i
ncom
pres
sibl
e -
the
ratio
of
uppe
r ar
m
circ
umfe
renc
e to
cuf
f w
idth
is o
f de
cisi
ve im
port
ance
to th
e ac
cura
cy.
Nat
iona
l org
anis
atio
ns, m
ostly
med
ical
ass
ocia
tions
, hav
e dr
awn
up r
ecom
men
datio
ns f
or s
uita
ble
cuff
s.
The
tabl
e sh
ows
the
Am
eric
an r
ecom
men
datio
ns.
Tab
le :
Cuf
f bl
adde
rs r
ecom
men
ded
by th
e A
mer
ican
Hea
rt A
ssoc
iatio
n
patie
ntup
per
arm
blad
der
of th
e cu
ff,
circ
umfe
renc
e
w
idth
* le
ngth
(cm
)(c
m *
cm
)ne
onat
es5
-7,
53
* 5
infa
nt7,
5 -
135
* 8
chil
d13
-20
8 *
13sm
all a
dult
17 -
2611
* 1
7ad
ult
24 -
3213
* 2
4la
rge
adul
t32
-42
17 *
32
thig
h42
-50
20 *
42
Osc
illom
etri
cm
etho
d
At t
he e
nd o
f th
e se
vent
ies,
aut
omat
ed s
phyg
mom
anom
eter
s ap
plyi
ng th
e os
cillo
met
ric
met
hod
wer
e de
velo
ped
for
the
firs
t tim
e. T
hey
wer
e ab
le to
det
erm
ine
the
syst
olic
and
dia
stol
ic b
lood
pre
ssur
e va
lues
by
mea
ns o
f m
athe
-mat
ical
algo
rith
ms.
Sim
ilar
to th
e K
orot
koff
met
hod,
the
osci
llom
etri
cm
etho
d m
akes
use
of
a cu
ff a
pplie
d to
the
uppe
r ar
m, h
owev
er, n
ost
etho
scop
e is
req
uire
d.
Add
ition
ally
the
mea
sure
men
t at t
he w
rist
is a
lso
poss
ible
. The
osc
illom
etri
cm
etho
d ca
n on
ly b
e ap
plie
d in
ele
ctro
nic
sphy
gmom
anom
eter
s; m
anua
l mea
sure
men
t by
the
doct
or w
ith th
e ai
d of
a
man
omet
er is
not
pra
ctic
able
.
The
mea
sure
men
t pro
cedu
re is
as
follo
ws:
-Fi
rst t
he c
uff
pres
sure
is p
umpe
d to
a v
alue
hig
her
than
the
expe
cted
sys
tolic
blo
od p
ress
ure.
-T
hen
the
cuff
pre
ssur
e is
def
late
d co
ntin
uous
ly o
r in
ste
ps.
-T
he p
ress
ure
puls
e in
the
arte
ria
brac
hial
is(a
t the
wri
st: a
. rad
ialis
and
a. u
lnar
is)
is tr
ansf
erre
d vi
a th
e bl
adde
r of
the
cuff
to th
e pn
eum
atic
sys
tem
of
the
inst
rum
ent a
nd r
esul
ts in
sm
all p
ress
ure
fluc
tuat
ions
(os
cilla
tions
). S
mal
l flu
ctua
tions
of
the
cuff
pre
ssur
e ca
n al
read
y be
obs
erve
d be
fore
the
syst
olic
blo
od p
ress
ure
valu
e is
rea
ched
. The
se p
ress
ure
fluc
tuat
ions
are
the
impo
rtan
t mea
sure
d va
lues
of
the
osci
llom
etri
cm
etho
d as
thei
r am
plitu
de c
hang
es w
hile
the
cuff
pre
ssur
e is
red
uced
fu
rthe
r.-
The
pai
red
valu
es o
f th
e os
cilla
tion
ampl
itude
s an
d th
e co
rres
pond
ing
cuff
pre
ssur
es a
re r
ecor
ded
duri
ng th
e m
easu
rem
ent.
The
se d
ata
are
mat
hem
atic
ally
eva
luat
ed a
fter
the
end
of th
e m
easu
rem
ent
and
the
resu
lts, i
.e.
the
bloo
d pr
essu
re v
alue
s, a
re d
ispl
ayed
.
Fig.
1:U
pper
par
t: cu
rve
of d
efla
ting
cuff
pre
ssur
e, lo
wer
par
t: am
plitu
de o
f pr
essu
re o
scill
atio
ns
The
mat
hem
atic
al p
roce
dure
s (a
lgor
ithm
s) a
pplie
d to
det
erm
ine
the
bloo
d pr
essu
re v
alue
s ar
e of
ten
cons
ider
ed a
s se
cret
s. W
ith th
e ex
cept
ion
of s
ome
deta
ils, t
he a
lgor
ithm
mos
t fre
quen
tly
used
is, h
owev
er,
gene
rally
kno
wn
and
will
be
disc
usse
d in
the
follo
win
g:
Aft
er th
e cu
ff p
ress
ure
was
def
late
d fr
om a
val
ue a
bove
the
syst
olic
blo
od p
ress
ure
to a
val
ue b
elow
the
dias
tolic
blo
od p
ress
ure,
the
valu
es o
f th
e os
cilla
tion
ampl
itude
s an
d of
the
res
pect
ive
cuff
pre
ssur
es a
re
stor
ed in
the
mem
ory.
Fig.
2 an
d 3
show
the
pres
sure
am
plitu
des
in th
e fo
rm o
f ve
rtic
al b
ars.
On
the
basi
s of
ext
ensi
ve in
vest
igat
ions
, the
fol
low
ing
rela
tions
hav
e be
en d
isco
vere
d:
1.
The
max
imum
of
the
osci
llat
ion
ampl
itud
e A
max
coin
cide
s w
ith th
e m
ean
arte
rial
blo
od p
ress
ure,
in s
hort
MA
P.
2.
The
sys
tolic
blo
od p
ress
ure
is d
eter
min
ed a
t abo
ut 0
.5A
max
.
3.
The
dia
stol
ic b
lood
pre
ssur
e is
det
erm
ined
at a
bout
0.8
Am
ax.
Not
e1:
Onl
y th
e pr
inci
ple
unde
rlyi
ng th
e pr
oced
ure
mos
t fre
quen
tly a
pplie
d h
as b
een
desc
ribe
d he
re; t
o im
prov
e its
relia
bilit
y, th
e m
etho
d ha
s be
en r
efin
ed a
nd e
xten
ded
in m
any
aspe
cts.
Not
e2:
The
fac
tors
giv
en a
bove
are
thos
e ro
ughl
y va
lid f
or m
easu
rem
ents
at th
e up
per
arm
. The
fac
tors
for
the
wri
st
are
tota
lly d
iffe
rent
.
15
sys
dia
Fig.
2:O
scill
omet
ric
prin
cipl
e
sys
dia
Fig.
3: O
scill
omet
ric
prin
cipl
e
Ove
rvie
w:
•M
edic
al b
ackg
roun
d
•T
echn
ique
s to
mea
sure
indi
rect
ly th
e bl
ood
pres
sure
•R
equi
rem
ents
, Sta
ndar
ds e
tc. f
or s
phyg
mom
anom
eter
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(pa
ttern
app
rova
l)
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(ve
rifi
catio
n)
OIM
L I
nter
nati
onal
Rec
omm
enda
tion
R16
(20
02)
R 1
6-1
Non
-inv
asiv
e m
echa
nica
l sph
ygm
oman
omet
ers
R 1
6-2
Non
-inv
asiv
e au
tom
ated
sph
ygm
oman
omet
ers
IEC
606
01-2
-30
(199
9)Pa
rtic
ular
req
uire
men
ts f
or th
e sa
fety
, inc
ludi
ng e
ssen
tial p
erfo
rman
ce,
of a
utom
atic
cyc
ling
non-
inva
sive
blo
od p
ress
ure
mon
itori
ng e
quip
men
t
CE
N E
N 1
060
(199
5-19
97-2
004)
Part
1: G
ener
al r
equi
rem
ents
Part
2: S
uppl
emen
tary
req
uire
men
ts f
or m
echa
nica
l sph
ygm
oman
omet
ers
Part
3: S
uppl
emen
tary
req
uire
men
ts f
or e
lect
ro-m
echa
nica
l blo
od p
ress
ure
mea
suri
ng s
yste
ms
Part
4: T
est p
roce
dure
s to
det
erm
ine
the
over
all s
yste
m a
ccur
acy
of a
utom
ated
no
n-in
vasi
ve s
phyg
mom
anom
eter
s
AN
SI/A
AM
I SP
10 (
2002
)M
anua
l, el
ectr
onic
, or
auto
mat
ed s
phyg
mom
anom
eter
s
16
Ove
rvie
w:
•M
edic
al b
ackg
roun
d
•T
echn
ique
s to
mea
sure
indi
rect
ly th
e bl
ood
pres
sure
•R
equi
rem
ents
, Sta
ndar
ds e
tc. f
or s
phyg
mom
anom
eter
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(pa
ttern
app
rova
l)
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(ve
rifi
catio
n)
OIM
L R
16-2
Non
-inv
asiv
e au
tom
ated
sph
ygm
oman
omet
ers
1 Sc
ope
Thi
s R
ecom
men
datio
n sp
ecif
ies
gene
ral,
perf
orm
ance
, eff
icie
ncy
and
mec
hani
cal a
nd e
lect
rica
l
safe
ty r
equi
rem
ents
, inc
ludi
ng te
st m
etho
ds f
or ty
pe a
ppro
val,
for
non-
inva
sive
ele
ctro
nic
or
auto
mat
ed s
phyg
mom
anom
eter
s an
d th
eir
acce
ssor
ies
whi
ch, b
y m
eans
of
an in
flat
able
cuf
f, a
re
used
for
the
non-
inva
sive
mea
sure
men
t of
arte
rial
blo
od p
ress
ure.
Thi
s R
ecom
men
datio
n on
ly a
pplie
s to
dev
ices
mea
suri
ng a
t the
upp
er a
rm, t
he w
rist
or
the
thig
h.
Not
e:L
uer
lock
s sh
all n
ot b
e us
ed w
ith th
ese
devi
ces
(see
6.1
1.3
and
7.5)
.
7.1
Typ
e ap
prov
al
At l
east
thre
e sa
mpl
es o
f a
new
type
of
sphy
gmom
anom
eter
sha
ll be
test
ed.
The
test
s to
ver
ify
conf
orm
ity to
met
rolo
gica
l and
tech
nica
l req
uire
men
ts s
hall
be c
arri
ed o
ut
acco
rdin
gto
Ann
ex A
. A te
st r
epor
t sha
ll be
pre
pare
d ac
cord
ing
to A
nnex
B.
4 U
nits
of
mea
sure
men
t
The
blo
od p
ress
ure
shal
l be
indi
cate
d ei
ther
in k
ilopa
scal
s (k
Pa)
or in
mill
imet
ers
of m
ercu
ry
(mm
Hg)
.
5 M
etro
logi
cal r
equi
rem
ents
5.1
Max
imum
per
mis
sibl
e er
rors
of
the
cuff
pre
ssur
e in
dica
tion
For
any
set o
f co
nditi
ons
with
in th
e am
bien
t tem
pera
ture
ran
ge o
f 15
°C
to 2
5 °C
and
the
rela
tive
hum
idity
ran
ge o
f 20
% to
85
%, b
oth
for
incr
easi
ng a
ndfo
r de
crea
sing
pre
ssur
e, th
e
max
imum
per
mis
sibl
e er
ror
for
the
mea
sure
men
t of
the
cuff
pre
ssur
e at
any
poi
nt o
f th
e
scal
e ra
nge
shal
l be
±0.
4 kP
a (±
3 m
mH
g) in
cas
eof
ver
ifyi
ng th
e fi
rst t
ime
and
±0.
5 kP
a
(±4
mm
Hg)
for
sph
ygm
oman
omet
ers
in u
se.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.2
.
A.1
Gen
eral
For
digi
tal i
ndic
atio
ns a
n un
cert
aint
y of
0.1
kPa
(1
mm
Hg)
sha
llbe
allo
wed
in a
ny d
ispl
ayed
val
ue,
beca
use
the
disp
lay
syst
em c
anno
t ind
icat
e a
chan
ge o
f le
ss th
anon
e un
it.
A.2
Met
hod
of t
est
for
the
max
imum
per
mis
sibl
e er
rors
of
the
cuff
pre
ssur
e in
dica
tion
Req
uire
men
ts in
5.1
sha
ll ap
ply.
A.2
.1 A
ppar
atus
•ri
gid
met
al v
esse
l with
a c
apac
ity o
f 50
0 m
l ±5
%;
•ca
libra
ted
refe
renc
e m
anom
eter
with
an
unce
rtai
nty
less
than
0.1
kPa
(0.
8 m
mH
g);
•pr
essu
re g
ener
ator
, e.g
. bal
l pum
p (h
and
pum
p) w
ith a
def
latio
nva
lve;
•T
-pie
ce c
onne
ctor
s an
d ho
ses.
A.2
.2 P
roce
dure
Rep
lace
the
cuff
with
the
vess
el. C
onne
ct th
e ca
libra
ted
refe
renc
e m
anom
eter
by
mea
ns o
f a
T-p
iece
con
nect
oran
d ho
ses
to th
e pn
eum
atic
cir
cuit
(see
Fig
ure
1). A
fter
dis
ablin
g th
e el
ectr
o-m
echa
nica
l pum
p (i
f fi
tted)
,con
nect
the
addi
tiona
l pr
essu
re g
ener
ator
into
the
pres
sure
sys
tem
by
mea
ns o
f an
othe
r T
-pie
ce c
onne
ctor
. C
arry
out
the
test
in p
ress
ure
step
s of
not
mor
e th
an 7
kPa
(50
mm
Hg)
bet
wee
n 0
kPa
(0 m
mH
g) a
nd th
e m
axim
um p
ress
ure
of th
e sc
ale
rang
e.*
*In
case
of
doub
t abo
ut th
e lin
eari
ty, s
pot c
heck
s sh
ould
be
carr
ied
out o
r th
e w
idth
of
the
pres
sure
ste
ps s
houl
d be
re
duce
d,i.e
., fr
om th
e no
rmal
ly r
ecom
men
ded
7 kP
a (5
0 m
mH
g) to
3 k
Pa (
20m
mH
g). T
his
also
app
lies
to T
able
1 in
A
nnex
B.
A.2
.3 E
xpre
ssio
n of
res
ults
Exp
ress
the
resu
lts a
s th
e di
ffer
ence
s be
twee
n th
e in
dica
ted
pres
sure
of
the
man
omet
er o
f th
e de
vice
to b
ete
sted
and
the
corr
espo
ndin
g re
adin
gs o
f th
e re
fere
nce
man
omet
er(s
ee B
.2).
17
1 -
Ref
eren
ce m
anom
eter
2 -
Dev
ice
to b
e te
sted
3 -
Met
al v
esse
l4
-Pr
essu
re g
ener
ator
Fig
ure
1M
easu
rem
ent s
yste
m f
or d
eter
min
ing
the
limits
of
erro
r of
the
cuff
pre
ssur
e in
dica
tion
Fig
ure:
Mea
sure
men
t se
tup
to d
eter
min
e th
e lim
its
of e
rror
of
the
cuff
pre
ssur
e in
dica
tion
(hom
e us
e de
vice
)
Fig
ure:
Mea
sure
men
t se
tup
to d
eter
min
e th
e lim
its
of e
rror
of
the
cuff
pre
ssur
e in
dica
tion
(ane
roid
man
omet
er)
5.2
Max
imum
per
mis
sibl
e er
rors
of
the
over
all s
yste
m a
s m
easu
red
by c
linic
al
test
s* (
* ca
rrie
d ou
t by
the
man
ufac
ture
r)
The
fol
low
ing
max
imum
per
mis
sibl
e er
rors
sha
ll ap
ply
for
the
over
all s
yste
m:
-m
axim
um m
ean
erro
r of
mea
sure
men
t: ±
0.7
kPa
(±5
mm
Hg)
;
-m
axim
um e
xper
imen
tal s
tand
ard
devi
atio
n: 1
.1 k
Pa (
8 m
mH
g).
For
furt
her
reco
mm
ende
d te
st m
etho
ds s
ee A
nnex
C.
18
Ann
ex C
Rat
iona
le f
or t
he m
axim
um p
erm
issi
ble
erro
rs o
f th
e ov
eral
l sys
tem
(Inf
orm
ativ
e)
Not
e:T
his
Ann
ex p
rovi
des
a ra
tiona
le f
or th
e va
lues
of
max
imum
per
mis
sibl
e er
rors
pre
sent
ed in
5.2
.
Ove
rall
syst
em a
ccur
acy
A c
linic
al in
vest
igat
ion
is s
tron
gly
reco
mm
ende
d to
dem
onst
rate
com
plia
nce
with
the
requ
irem
ents
spe
cifi
ed in
5.2
.
A n
ew c
linic
al in
vest
igat
ion
wou
ld b
e ne
cess
ary
only
for
cha
nges
affe
ctin
g th
e ov
eral
l sys
tem
acc
urac
y.R
ecom
men
ded
prot
ocol
s fo
r th
e cl
inic
al in
vest
igat
ions
are
giv
en in
:
C.1
O’B
rien
E.,
Petr
ie J
., L
ittle
r W
., de
Sw
ietM
., Pa
dfie
ldP.
L.,
Altm
an D
.G.,
Bla
nd M
., C
oats
A. a
nd A
tkin
s N
. T
he B
ritis
h H
yper
tens
ion
Soci
ety
prot
ocol
for
the
eval
uatio
n of
blo
od m
easu
ring
dev
ices
. Jou
rnal
of
Hyp
erte
nsio
n 19
93, 1
1 (S
uppl
2): S
43
-62
C.2
E D
IN 5
8130
: 199
5, N
on-i
nvas
ive
sphy
gmom
anom
eter
s -
Clin
ical
inve
stig
atio
n
C.3
AA
MI/
AN
SI S
P10,
Am
eric
an N
atio
nal S
tand
ard
for
elec
tron
ic o
rau
tom
ated
sph
ygm
oman
omet
ers,
199
2, a
nd
Am
endm
ent,
1996
Subs
titut
edby
: EN
106
0-4
Non
-inv
asiv
e sp
hygm
oman
omet
ers
-T
est p
roce
dure
s to
det
erm
ine
the
over
all s
yste
m
accu
racy
of
auto
mat
ed n
on-i
nvas
ive
sphy
gmom
anom
eter
sFi
g: C
linic
al te
st s
et-u
p ac
cord
ing
EN
106
0-4
for
devi
ces
with
def
latio
n ra
tes
up to
3 m
mH
g/s.
Fig.
: Clin
ical
test
set
-up
acco
rdin
g E
N 1
060-
4 fo
r de
vice
s w
ith d
efla
tion
rate
s hi
gher
than
3 m
mH
g/s
(seq
uent
ial m
easu
rem
ent)
.
t 1t 2
Fig.
: Clin
ical
test
set
-up
acco
rdin
g E
N 1
060-
4 fo
r de
vice
s w
ith d
efla
tion
rate
s hi
gher
than
3 m
mH
g/s
(seq
uent
ial m
easu
rem
ent)
.
t 1t 2
19
5.3
Env
iron
men
tal p
erfo
rman
ce
5.3.
1 St
orag
e
Blo
od p
ress
ure
mea
suri
ng s
yste
ms
shal
l mai
ntai
n th
e re
quir
emen
tssp
ecif
ied
in th
is R
ecom
men
datio
n
afte
rst
orag
e fo
r 24
h a
t a te
mpe
ratu
re o
f –
5 °C
and
for
24
h at
a te
mpe
ratu
re o
f 50
°C
and
a r
elat
ive
hum
idity
of
85 %
(no
n-co
nden
sing
).
Tes
ting
shal
l be
carr
ied
out a
t env
iron
men
tal c
ondi
tions
(se
e 5.
1) in
acc
orda
nce
with
A.2
aft
er th
e te
st
sam
ple
has
been
pla
ced
for
24 h
at a
tem
pera
ture
of
–5
°C a
nd im
med
iate
ly a
fter
war
ds f
or 2
4 h
at a
tem
pera
ture
of
50 °
C in
a c
limat
ic c
ham
ber.
Not
e:In
tegr
ated
mul
tipar
amet
erm
onito
rs m
ay c
onta
in c
ompo
nent
s w
hich
may
be
dam
aged
dur
ing
stor
age.
The
gen
eral
tem
pera
ture
ran
ge a
s st
ated
in A
.3 h
as th
eref
ore
been
red
uced
com
pare
d to
the
requ
irem
ents
in R
16-
1.
A.2
Met
hod
of t
est
for
the
max
imum
per
mis
sibl
e er
rors
of
the
cuff
pre
ssur
e in
dica
tion
......
......
......
......
....
5.3.
2 Te
mpe
ratu
re, r
elat
ive
hum
idity
For
the
ambi
ent t
empe
ratu
re r
ange
of
10 °
C to
40
°C a
nd a
rel
ativ
e hu
mid
ity o
f 85
% (
non-
cond
ensi
ng),
the
diff
eren
ce o
f th
e cu
ff p
ress
ure
indi
catio
n of
the
sphy
gmom
anom
eter
sha
ll
not e
xcee
d ±
0.4
kPa
(±3
mm
Hg)
.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.2
and
A.1
1.
The
sig
nal p
roce
ssin
g fo
r th
e de
term
inat
ion
of th
e bl
ood
pres
sure
val
ues
shal
l not
be
infl
uenc
ed w
ithin
the
rang
e of
tem
pera
ture
and
rel
ativ
e hu
mid
ity. F
or a
ny s
et o
f co
nditi
ons
all t
he d
evia
tions
bet
wee
n th
ere
fere
nce
pres
sure
and
the
indi
catin
g cu
ff p
ress
ure
of th
e
inst
rum
ent m
ust b
e le
ss th
an o
r eq
ual t
o th
em
axim
um p
erm
issi
ble
erro
r.
1 -
Ref
eren
ce m
anom
eter
2
-C
limat
ic c
ham
ber
3 -
Dev
ice
to b
e te
sted
4 -
Met
al v
esse
l5
-Pr
essu
re g
ener
ator
Fig
ure:
Mea
sure
men
t sys
tem
for
det
erm
inin
g th
e in
flue
nce
of te
mpe
ratu
re
5.3.
2 Te
mpe
ratu
re, r
elat
ive
hum
idity
For
the
ambi
ent t
empe
ratu
re r
ange
of
10 °
C to
40
°C a
nd a
rel
ativ
e hu
mid
ity o
f 85
% (
non-
cond
ensi
ng),
the
diff
eren
ce o
f th
e cu
ff p
ress
ure
indi
catio
n of
the
sphy
gmom
anom
eter
sha
ll no
t ex
ceed
±0.
4 kP
a (±
3 m
mH
g).
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.2
and
A.1
1.
The
sig
nal p
roce
ssin
g fo
r th
e de
term
inat
ion
of th
e bl
ood
pres
sure
val
ues
shal
l not
be
infl
uenc
ed
with
inth
e ra
nge
of te
mpe
ratu
re a
nd r
elat
ive
hum
idity
. For
any
set
of
cond
ition
s al
l the
de
viat
ions
bet
wee
n th
ere
fere
nce
pres
sure
and
the
indi
catin
g cu
ff p
ress
ure
of th
e in
stru
men
t m
ust b
e le
ss th
an o
r eq
ual t
o th
em
axim
um p
erm
issi
ble
erro
r.
A.2
Met
hod
of t
est
for
the
max
imum
per
mis
sibl
e er
rors
of
the
cuff
pre
ssur
e in
dica
tion
......
......
......
......
...
A.1
1 T
est
met
hod
for
the
stab
ility
of
the
bloo
d pr
essu
re d
eter
min
atio
n(i
nflu
ence
of
tem
pera
ture
and
hum
idit
y)
A.1
1.1
App
arat
us•
patie
nt s
imul
ator
as
desc
ribe
d in
A.5
.1.1
;•
clim
atic
cha
mbe
r, c
apab
le o
f ad
just
men
t to
anac
cura
cy o
f 1
°C f
or th
e te
mpe
ratu
re a
nd 5
% f
or
the
rela
tive
hum
idity
.
20
A.1
1.2
Pro
cedu
re
Car
ry o
ut th
e te
stin
g of
the
sign
al p
roce
ssin
g by
mea
ns o
f th
e pa
tient
sim
ulat
or. F
or e
ach
of th
e fo
llow
ing
com
bina
tions
of
tem
pera
ture
and
hum
idity
, pla
ce th
e bl
ood
pres
sure
mea
suri
ng s
yste
m f
or a
t lea
st 3
h in
the
clim
atic
cha
mbe
r to
allo
w th
e sy
stem
to r
each
ste
ady
cond
ition
s:
•10
°C
am
bien
t tem
pera
ture
, 85
% r
elat
ive
hum
idity
(no
n-co
nden
sing
);
•20
°C
am
bien
t tem
pera
ture
, 85
% r
elat
ive
hum
idity
(no
n-co
nden
sing
);
•40
°C
am
bien
t tem
pera
ture
, 85
% r
elat
ive
hum
idity
(no
n-co
nden
sing
).
For
each
com
bina
tion
of te
mpe
ratu
re a
nd h
umid
ity, t
ake
20 c
onse
cutiv
e re
adin
gs o
f th
e bl
ood
pres
sure
mea
suri
ng s
yste
m u
nder
test
.
Plac
e th
e bl
ood
pres
sure
mea
suri
ng s
yste
m in
the
clim
atic
cha
mbe
r fo
r at
leas
t 3 h
. At e
ach
com
bina
tion
of te
mpe
ratu
re a
nd h
umid
ity s
witc
h on
the
bloo
d pr
essu
re m
easu
ring
sys
tem
bef
ore
star
ting
the
test
.
Wai
t unt
il th
e w
arm
up
time
(des
crib
ed in
the
inst
ruct
ions
for
use
) ha
s el
apse
d, c
arry
out
the
mea
sure
-
men
t(20
con
secu
tive
read
ings
) an
d sw
itch
off
the
bloo
d pr
essu
re m
easu
ring
sys
tem
aft
erw
ards
.
A.1
1.3
Exp
ress
ion
of r
esul
ts
Det
erm
ine
the
mea
n va
lue
(sys
tolic
and
dia
stol
ic v
alue
s se
para
tely
) of
the
20 c
onse
cutiv
e re
adin
gs ta
ken
at
each
com
bina
tion
of te
mpe
ratu
re a
nd h
umid
ity.
Not
e:B
ecau
se th
e te
stin
g of
the
infl
uenc
e of
tem
pera
ture
and
hum
idity
for
the
sign
al p
roce
ssin
g ca
nnot
be
sepa
rate
d fr
om th
e te
mpe
ratu
re/h
umid
ity e
ffec
t on
the
pres
sure
tran
sduc
er a
nd th
e de
viat
ions
ori
gina
ting
from
the
sim
ulat
or, b
oth
cont
ribu
tions
sho
uld
be ta
ken
into
acc
ount
for
the
eval
uatio
n of
the
test
.
Fig
ure:
Mea
sure
men
t se
tup
to d
eter
min
e th
e st
abili
ty o
f th
e bl
ood
pres
sure
det
erm
inat
ion;
left
: si
mul
ator
, rig
ht o
pen
clim
atic
cha
mbe
r w
ith
auto
mat
ed s
phyg
mom
anom
eter
6T
echn
ical
req
uire
men
ts
6.1
Gen
eral
Equ
ipm
ent,
or p
arts
ther
eof,
usi
ng m
ater
ials
or
havi
ng f
orm
s of
con
stru
ctio
n di
ffer
ent f
rom
thos
e de
taile
d in
this
R
ecom
men
datio
n sh
all b
e ac
cept
ed if
it c
an b
e de
mon
stra
ted
that
an
equi
vale
nt d
egre
e of
saf
ety
and
perf
orm
ance
is
obta
ined
.
6.2
Tec
hnic
al r
equi
rem
ents
for
the
cuf
f an
d bl
adde
rT
he c
uff
shal
l con
tain
a b
ladd
er. F
or r
eusa
ble
cuff
s th
e m
anuf
actu
rer
shal
l ind
icat
e th
e m
etho
d fo
r cl
eani
ng in
the
acco
mpa
nyin
g do
cum
ents
(se
e 7.
5).
Not
e:T
he o
ptim
um b
ladd
er s
ize
is o
ne w
ith d
imen
sion
s su
ch th
at it
s w
idth
is 4
0 %
of
the
limb
circ
umfe
renc
e at
the
mid
poin
t of
the
cuff
app
licat
ion
and
its le
ngth
is a
t lea
st 8
0 %
, pre
fera
bly
100
% o
f th
e lim
b ci
rcum
fere
nce
at th
e m
idpo
int o
f cu
ff a
pplic
atio
n. U
se o
f th
e w
rong
siz
e ca
n af
fect
the
accu
racy
of
the
mea
sure
men
t.
6.3
Tec
hnic
al r
equi
rem
ents
for
the
dis
play
The
dis
play
sha
ll be
des
igne
d an
d ar
rang
ed s
o th
at th
e in
form
atio
n in
clud
ing
mea
suri
ng v
alue
s ca
n be
rea
dan
d ea
sily
re
cogn
ized
.
Tes
ting
shal
l be
carr
ied
out b
y vi
sual
insp
ectio
n.
If a
bbre
viat
ions
are
use
d on
the
disp
lay
they
sha
ll be
as
follo
ws:
•“S
”or
“SY
S”: s
ysto
lic b
lood
pre
ssur
e (v
alue
);•
“D”
or “
DIA
”: d
iast
olic
blo
od p
ress
ure
(val
ue);
•“M
”or
“M
AP”
: mea
n ar
teri
al b
lood
pre
ssur
e (v
alue
).
Sing
le le
tter
abbr
evia
tions
sha
ll be
pos
ition
ed in
suc
h a
way
toav
oid
conf
usio
n w
ith S
I un
its.
6.4
Eff
ect
of v
olta
ge v
aria
tion
s of
the
pow
er s
ourc
e
6.4.
1 In
tern
al e
lect
rica
l pow
er s
ourc
e
6.4.
1.1
Cha
nges
of
the
volta
ge w
ithin
the
wor
king
ran
ge d
eter
min
ed a
ccor
ding
to A
.4.1
sha
ll no
t inf
luen
ce
the
cuff
pre
ssur
e re
adin
g an
d th
e re
sult
of th
e bl
ood
pres
sure
mea
sure
men
t.
6.4.
1.2
Out
side
this
wor
king
ran
ge n
o cu
ff p
ress
ure
read
ing
and
no r
esul
t of
the
bloo
d pr
essu
re
mea
sure
men
t sha
ll be
dis
play
ed.
6.4.
2 E
xter
nal e
lect
rica
l pow
er s
ourc
e
6.4.
2.1
Cha
nges
of
the
volta
ge w
ithin
the
wor
king
ran
ge s
peci
fied
by
the
man
ufac
ture
r (s
ee 7
.5)
shal
l not
infl
uenc
e th
e cu
ff p
ress
ure
read
ing
and
the
resu
lt of
the
bloo
d pr
essu
re m
easu
rem
ent.
6.4.
2.2
Inco
rrec
t val
ues
resu
lting
fro
m v
olta
ge v
aria
tions
out
side
the
limits
giv
en in
6.4
.2.1
sha
ll no
t be
disp
laye
d.
Not
e:In
the
case
of
any
mal
func
tion
of th
e eq
uipm
ent,
defl
atio
n to
bel
ow 2
kPa
(15
mm
Hg)
mus
t be
guar
ante
ed w
ithin
180
s in
the
case
of
adul
t pat
ient
s an
d to
bel
ow 0
.7 k
Pa (
5 m
mH
g) w
ithin
90
s in
the
case
of
neon
atal
/infa
nt p
atie
nts.
21
6.5
Pne
umat
ic s
yste
m
6.5.
1 A
ir le
akag
e
Air
leak
age
shal
l not
exc
eed
a pr
essu
re d
rop
of 0
.8 k
Pa/m
in (
6 m
mH
g/m
in).
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.6
.
6.5.
2 P
ress
ure
redu
cing
sys
tem
for
devi
ces
usin
g th
e au
scul
tato
rym
etho
d
The
pre
ssur
e re
duci
ng s
yste
m f
or m
anua
lly o
pera
ted
and
auto
mat
edde
flat
ion
valv
es s
hall
be
capa
ble
ofm
aint
aini
ng a
def
latio
n ra
te o
f 0.
3 kP
a/s
to 0
.4 k
Pa/s
(2
mm
Hg/
sto
3 m
mH
g/s)
with
in th
e ta
rget
ran
ge o
fsy
stol
ic a
nd d
iast
olic
blo
od p
ress
ure.
For
dev
ices
whi
ch c
ontr
olth
e
pres
sure
red
uctio
n as
a f
unct
ion
of th
epu
lse
rate
, a d
efla
tion
rate
of
0.3
kPa/
puls
e to
0.4
kPa/
puls
e (2
mm
Hg/
puls
e to
3 m
mH
g/pu
lse)
sha
ll be
mai
ntai
ned.
Not
e:M
anua
lly o
pera
ted
defl
atio
n va
lves
sho
uld
be e
asily
adj
usta
ble
to th
ese
valu
es.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.7
.
Fig
ure:
Air
leak
age
test
set
-up
A.7
Met
hod
of t
est
for
the
pres
sure
red
ucti
on r
ate
A.7
.1 A
ppar
atus
•T
-pie
ce c
onne
ctor
s;•
calib
rate
d re
fere
nce
man
omet
er w
ith s
igna
l out
put p
ort a
nd a
n un
cert
aint
y le
ss th
an 0
.1 k
Pa (
0.8m
mH
g);
•ar
tific
ial o
r hu
man
lim
bs (
see
Not
esun
der
A.7
.2);
•re
cord
ing
unit.
A.7
.2 P
roce
dure
Mea
sure
the
pres
sure
red
uctio
n ra
te e
ither
on
hum
an s
ubje
cts
or a
rtif
icia
l lim
bs.
Not
e 1:
The
inte
ntio
n is
to u
se a
rtif
icia
l lim
bs, b
ut a
s th
ese
are
still
unde
r co
nsid
erat
ion,
mea
sure
men
tspe
rfor
med
with
hum
an v
olun
teer
s ar
e ac
cept
able
.
Not
e 2:
Tw
o lim
b si
zes
shou
ld b
e us
ed, b
eing
equ
al to
the
uppe
r an
d lo
wer
lim
its o
f lim
b ci
rcum
fere
nces
with
whi
ch a
par
ticul
ar s
ize
of c
uff
is r
ecom
men
ded
for
use.
Not
e 3:
It i
s in
tend
ed th
at th
e ch
arac
teri
stic
s of
the
artif
icia
l lim
bs r
efle
ct s
ome
elas
tic c
hara
cter
istic
sof
hu
man
lim
bs.
Bec
ause
the
cuff
def
latio
n ra
te m
ay b
e in
flue
nced
by
the
way
that
a c
uff
is a
pplie
d, a
pply
and
rem
ove
the
cuff
for
eac
h of
at l
east
ten
repe
ated
mea
sure
men
ts o
n at
leas
t tw
o di
ffer
ent l
imb
size
s. T
he d
efla
tion
may
be
rese
t.C
onne
ct th
e ca
libra
ted
refe
renc
e m
anom
eter
to th
e cu
ff b
y m
eans
of
a T
-pie
ce. C
onne
ct th
e ou
tput
par
t of
the
calib
rate
d re
fere
nce
man
omet
er to
the
reco
rdin
g un
it.
A.7
.3 E
xpre
ssio
n of
res
ults
Det
erm
ine
the
rate
of
pres
sure
red
uctio
n (e
.g. b
y gr
aphi
cal e
valu
atio
n an
d dr
awin
g
tang
ents
) at
the
pres
sure
val
ues
8 kP
a (6
0 m
mH
g), 1
6 kP
a (1
20 m
mH
g) a
nd 2
4 kP
a
(180
mm
Hg)
. Cal
cula
te th
e pr
essu
re r
educ
tion
rate
as
the
mea
n va
lue
calc
ulat
ed
sepa
rate
ly f
or th
e pr
essu
re v
alue
s 8
kPa
(60
mm
Hg)
, 16
kPa
(120
mm
Hg)
and
24
kPa
(180
mm
Hg)
and
for
the
vari
ous
limb
circ
umfe
renc
es. I
f th
e pr
essu
re
redu
ctio
n ra
tes
are
depe
nden
t on
the
puls
e, r
ecor
d th
e pu
lse
rate
. In
this
cas
e,
expr
ess
the
resu
lt as
pre
ssur
e re
duct
ion
rate
per
pul
se.
22
6.5.
3 R
apid
exh
aust
Dur
ing
the
rapi
d ex
haus
t of
the
pneu
mat
ic s
yste
m, w
ith th
e va
lve
fully
ope
ned,
the
time
for
the
pres
sure
redu
ctio
n fr
om 3
5 kP
a to
2 k
Pa (
260
mm
Hg
to 1
5 m
mH
g) s
hall
not e
xcee
d 10
s.
For
bloo
d pr
essu
re m
easu
ring
sys
tem
s ha
ving
the
capa
bilit
y to
mea
sure
in a
neo
nata
l/inf
ant m
ode,
the
time
for
the
pres
sure
red
uctio
n fr
om 2
0 kP
a to
0.7
kPa
(15
0 m
mH
gto
5 m
mH
g) d
urin
g th
e ra
pid
exha
ust
of th
e pn
eum
atic
sys
tem
with
the
valv
e fu
lly o
pene
d sh
all n
ot e
xcee
d 5
s.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A8.
A.8
Met
hod
of t
est
for
the
rapi
d ex
haus
t va
lve
A.8
.1 A
ppar
atus
•tw
o ri
gid
vess
els
with
cap
aciti
es o
f 10
0 m
l ±5
% a
nd 5
00 m
l ±5
%, r
espe
ctiv
ely;
•ca
libra
ted
refe
renc
e m
anom
eter
with
an
unce
rtai
nty
less
than
0.1
kPa
(0.
8 m
mH
g);
•T
-pie
ce c
onne
ctor
;•
stop
wat
ch.
A.8
.2 P
roce
dure
Car
ry o
ut th
e te
st w
ith th
e 50
0 m
l ves
sel i
n pl
ace
of th
e cu
ff. F
or b
lood
pre
ssur
e m
easu
ring
sys
tem
s ha
ving
the
capa
bilit
y of
mea
suri
ng in
a n
eona
tal/i
nfan
t mod
e an
d fo
r de
vice
s m
easu
ring
at t
he w
rist
, ca
rry
out t
he te
stw
ith th
e 10
0 m
l ves
sel i
n pl
ace
of th
e cu
ff. C
onne
ct th
e ca
libra
ted
refe
renc
e m
anom
eter
by
mea
ns o
f a
T-p
iece
to th
e pn
eum
atic
sys
tem
. Inf
late
at l
east
to th
e m
axim
um p
ress
ure
give
n in
6.5
.3,
wai
t 60
s an
d ac
tivat
e th
e ra
pid
exha
ust v
alve
. Mea
sure
the
time
betw
een
the
pres
sure
val
ues
spec
ifie
d in
6.
5.3
usin
g th
e st
opw
atch
.
A.8
.3 E
xpre
ssio
n of
res
ults
Exp
ress
the
resu
lts a
s th
e m
easu
red
exha
ust t
imes
.
6.5.
4 Ze
ro s
ettin
gB
lood
pre
ssur
e m
easu
ring
sys
tem
s sh
all b
e ca
pabl
e of
aut
omat
ic z
ero
setti
ng. T
he z
ero
setti
ng s
hall
be
carr
ied
out a
t app
ropr
iate
inte
rval
s, a
t lea
st s
tart
ing
afte
r sw
itchi
ng o
n th
e de
vice
.
At t
he m
omen
t of
the
zero
set
ting
a ga
uge
pres
sure
of
0 kP
a (0
mm
Hg)
sha
ll ex
ist a
nd b
e di
spla
yed
ther
eaft
er.
Dev
ices
per
form
ing
zero
set
ting
only
imm
edia
tely
aft
er s
witc
hing
on, s
hall
switc
h of
f au
tom
atic
ally
whe
n th
e dr
ift o
f th
e pr
essu
re tr
ansd
ucer
and
the
anal
ogsi
gnal
pro
cess
ing
exce
eds
0.1
kPa
(1 m
mH
g).
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.9
and
A.1
0.
Figu
re: A
pply
ing
posi
tive
or n
egat
ive
pres
sure
at t
he m
omen
t of
zero
set
ting
will
res
ult i
n a
decr
ease
or
incr
ease
of
volta
ge (
or d
ispl
ayed
pre
ssur
e), t
hus
prov
ing
that
the
zero
set
ting
soft
war
e w
orks
cor
rect
ly.
A.9
Tes
t m
etho
d fo
r th
e ze
ro s
etti
ng
A.9
.1 A
ppar
atus
•ri
gid
vess
el w
ith a
cap
acity
of
500
ml ±
5 %
;•
calib
rate
d re
fere
nce
man
omet
er w
ith a
n un
cert
aint
y le
ss th
an 0
.1 k
Pa (
0.8
mm
Hg)
;•
elec
tro-
mec
hani
cal p
ress
ure/
suct
ion
pum
p;•
pres
sure
gen
erat
or, e
.g. b
all p
ump
(han
d pu
mp)
with
def
latio
n va
lve;
•T
-pie
ce c
onne
ctor
s;•
hose
s.
A.9
.2 P
roce
dure
and
eva
luat
ion
If, b
ecau
se o
f te
chni
cal r
easo
ns, t
he te
st a
s de
scri
bed
in th
is s
ubcl
ause
cann
ot b
e pe
rfor
med
, use
an
alte
rnat
ive
test
pro
cedu
re s
peci
fied
by
the
man
ufac
ture
r. T
o te
st th
e fu
nctio
n of
the
zero
set
ting,
app
ly a
pre
ssur
e of
+ 0
.8
kPa
(+ 6
mm
Hg)
and
sub
sequ
ently
–0.
8 kP
a (–
6 m
mH
g) to
the
pneu
mat
ic s
yste
m a
nd in
itiat
e a
zero
set
ting
of th
e de
vice
. Ens
ure
that
all
disp
laye
d pr
essu
re v
alue
s ha
ve a
sys
tem
atic
err
or o
f –
0.8
kPa
(–6
mm
Hg)
and
+
0.8
kPa
(+
6 m
mH
g), r
espe
ctiv
ely.
Bef
ore
begi
nnin
g th
e te
st, a
llow
the
bloo
d pr
essu
re m
easu
ring
sys
tem
to
reac
h w
orki
ng te
mpe
ratu
re.
Set u
p th
e bl
ood
pres
sure
mea
suri
ng s
yste
m to
be
test
ed a
s fo
llow
s:•
repl
ace
the
cuff
with
the
500
ml v
esse
l;•
inse
rt th
e ca
libra
ted
refe
renc
e m
anom
eter
into
the
pneu
mat
ic s
yste
m b
y m
eans
of
a T
-pie
ce c
onne
ctor
;•
inse
rt th
e pr
essu
re/s
uctio
n pu
mp
into
the
pneu
mat
ic s
yste
m b
y m
eans
of
a T
-pie
ce c
onne
ctor
;•
inse
rt th
e pr
essu
re g
ener
ator
into
the
pneu
mat
ic s
yste
m b
y m
eans
of
a T
-pie
ce c
onne
ctor
.
Not
e:If
con
veni
ent,
one
adju
stab
le p
ump
may
be
used
in p
lace
of
the
pres
sure
/suc
tion
pum
p an
d pr
essu
re
gene
rato
r to
gen
erat
e th
e pr
essu
res.
Proc
eed
in th
e fo
llow
ing
way
:
a) I
nitia
te a
zer
o se
tting
as
desc
ribe
d by
the
man
ufac
ture
r. S
etth
e bl
ood
pres
sure
mea
suri
ng
syst
em to
the
serv
ice
mod
e, if
ava
ilabl
e. R
aise
the
pres
sure
to 1
3 kP
a (1
00 m
mH
g) im
med
iate
ly
afte
rwar
ds a
nd r
ecor
d th
e di
spla
yed
valu
e.
b) G
ener
ate
a co
nsta
nt g
auge
pre
ssur
e of
+ 0
.8 k
Pa (
+ 6
mm
Hg)
inth
e pn
eum
atic
sys
tem
by
usin
g th
e
pres
sure
/suc
tion
pum
p at
the
mom
ent o
f ze
ro s
ettin
g. D
urin
g th
ispe
riod
clo
se th
e de
flat
ion
valv
e
of th
e de
vice
und
er te
st o
r cl
ose
the
hose
to it
, e.g
. by
pinc
hing
the
hose
tigh
tly. S
et th
e bl
ood
pres
sure
mea
suri
ng s
yste
m to
the
serv
ice
mod
e, if
ava
ilabl
e. R
aise
the
pres
sure
to 1
3 kP
a (1
00 m
mH
g)
imm
edia
tely
aft
erw
ards
. The
zer
o se
tting
is o
pera
ting
corr
ectly
if th
e di
spla
yed
valu
e de
crea
ses
by 0
.8 k
Pa (
6 m
mH
g) c
ompa
red
to th
e va
lue
take
n in
a).
c) R
epea
t b)
with
a c
onst
ant g
auge
pre
ssur
e of
–0.
8 kP
a (–
6 m
mH
g) in
the
pneu
mat
ic s
yste
m. S
et
the
bloo
d pr
essu
re m
easu
ring
sys
tem
to th
e se
rvic
e m
ode,
if a
vaila
ble.
Rai
se th
e pr
essu
re to
13
kPa
(100
mm
Hg)
imm
edia
tely
aft
erw
ards
. The
zer
o se
tting
is o
pera
ting
corr
ectly
if th
e di
spla
yed
valu
e
incr
ease
s by
0.8
kPa
(6
mm
Hg)
com
pare
d to
the
valu
e ta
ken
in a
).
23
A.1
0 T
est
met
hod
for
the
drif
t of
the
cuf
f pr
essu
re in
dica
tion
A.1
0.1
Gen
eral
Thi
s te
st a
pplie
s fo
r de
vice
s pe
rfor
min
g ze
ro s
ettin
g on
ly im
med
iate
ly a
fter
sw
itchi
ng o
n.
A.1
0.2
App
arat
us
•ri
gid
vess
el w
ith a
cap
acity
of
500
ml ±
5 %
;
•ca
libra
ted
refe
renc
e m
anom
eter
with
an
unce
rtai
nty
less
than
0.1
kPa
(0.
8 m
mH
g);
•st
opw
atch
;
•T
-pie
ce c
onne
ctor
s;
•pa
tient
sim
ulat
or a
s de
scri
bed
in A
.5.1
.1.
A.1
0.3
Pro
cedu
re a
nd e
valu
atio
n
Rep
lace
the
cuff
with
the
500
ml v
esse
l. In
sert
the
calib
rate
d re
fere
nce
man
omet
er a
nd th
e pa
tient
sim
ulat
or in
to th
e pn
eum
atic
cir
cuit
by m
eans
of
T-p
iece
con
nect
ors.
Bef
ore
begi
nnin
g th
e te
st, a
llow
the
bloo
d pr
essu
re m
easu
ring
sys
tem
to r
each
ope
ratin
g te
mpe
ratu
re a
s
desc
ribe
d in
the
inst
ruct
ions
for
use
. Tes
t the
sta
bilit
y of
the
cuff
pre
ssur
e in
dica
tion
afte
r th
e ze
ro
setti
ng a
t a p
ress
ure
valu
e of
7 k
Pa (
50 m
mH
g) a
ccor
ding
to th
e pr
oced
ure
spec
ifie
d in
A.2
. Und
er th
e
sam
e en
viro
nmen
tal c
ondi
tions
det
erm
ine
the
time
(t1)
unt
il th
e ch
ange
of
the
cuff
pre
ssur
e in
dica
tion
exce
eds
0.1
kPa
(1 m
mH
g). S
witc
h of
f th
e de
vice
and
sw
itch
on a
fter
war
ds. P
erfo
rm o
ne b
lood
pre
ssur
e
mea
sure
men
t and
wai
t unt
il th
e de
vice
has
sw
itche
d of
f au
tom
atic
ally
. Det
erm
ine
the
time
(t2)
bet
wee
n
switc
hing
on
and
auto
mat
ical
ly s
witc
hing
off
. The
tim
e (t
2) s
hall
be le
ss th
an o
r eq
ual t
o th
e tim
e (t
1).
6.6
Ele
ctro
mag
neti
c co
mpa
tibi
lity
Eith
er:
•el
ectr
ical
and
/or
elec
trom
agne
tic in
terf
eren
ces
shal
l not
lead
to d
egra
datio
ns in
the
cuff
pres
sure
indi
catio
n or
in th
e re
sult
of th
e bl
ood
pres
sure
mea
sure
men
t; or
•if
ele
ctri
cal a
nd/o
r el
ectr
omag
netic
inte
rfer
ence
s le
ad to
an
abno
rmal
ity, t
he a
bnor
mal
ity
shal
l be
clea
rly
indi
cate
d an
d it
shal
l be
poss
ible
to r
esto
re n
orm
al o
pera
tion
with
in 3
0 s
afte
r ce
ssat
ion
of th
e el
ectr
omag
netic
dis
turb
ance
.
Tes
ting
shou
ld b
e ca
rrie
d ou
t in
acco
rdan
ce w
ith th
e re
leva
nt O
IML
pro
visi
ons
(not
ably
thos
e of
OIM
L D
11)
.
6.7
Stab
ility
of
the
cuff
pre
ssur
e in
dica
tion
The
cha
nge
in th
e cu
ff p
ress
ure
indi
catio
n sh
all n
ot b
e m
ore
than
0.4
kPa
(3
mm
Hg)
thro
ugho
ut th
e pr
essu
re
rang
e af
ter
10 0
00 s
imul
ated
mea
sure
men
t cyc
les.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.1
2.
A.1
2 T
est
met
hod
for
the
stab
ility
of
cuff
pre
ssur
e in
dica
tion
fol
low
ing
prol
onge
d us
age
A.1
2.1
Pro
cedu
re
Car
ry o
ut th
e te
st a
ccor
ding
to th
e pr
oced
ure
spec
ifie
d in
A.2
pri
or to
pro
long
ed u
sage
.
Perf
orm
10
000
sim
ulat
ed m
easu
rem
ent c
ycle
s w
ith th
e co
mpl
ete
bloo
d pr
essu
re m
easu
rem
ent s
yste
m a
t
whi
chat
leas
t the
fol
low
ing
cuff
pre
ssur
e va
lues
sha
ll be
rea
ched
:
•ad
ult m
ode:
20
kPa
(150
mm
Hg)
;
•ne
onat
al/in
fant
mod
e: 1
0 kP
a (7
5 m
mH
g).
Not
e 1:
For
dev
ices
whi
ch m
easu
re w
ith th
e au
scul
tato
ryan
d os
cillo
met
ric
met
hod
this
test
sho
uld
be c
arri
ed o
ut f
or b
oth
mod
es.
Not
e 2:
For
dev
ices
whi
ch m
easu
re in
bot
h m
odes
(ad
ult a
nd n
eona
tal/i
nfan
t) th
e te
st s
houl
d be
carr
ied
out i
n bo
th m
odes
.
A.1
2.2
Exp
ress
ion
of r
esul
ts
Exp
ress
the
resu
lt as
the
diff
eren
ce b
etw
een
the
cuff
pre
ssur
e in
dica
tion
befo
re a
nd a
fter
10
000
sim
ulat
ed
bloo
d pr
essu
re m
easu
rem
ent c
ycle
s at
the
sam
e te
st p
ress
ure
and
unde
r th
e sa
me
envi
ronm
enta
l con
ditio
ns.
6.8
Pre
ssur
e in
dica
ting
dev
ice
6.8.
1 N
omin
al r
ange
and
mea
suri
ng r
ange
The
nom
inal
ran
ge f
or th
e cu
ff p
ress
ure
mea
sure
men
t sha
ll be
spe
cifi
ed b
y th
e m
anuf
actu
rer.
The
mea
suri
ngan
d in
dica
tion
rang
es o
f th
e cu
ff p
ress
ure
shal
l be
equa
l to
the
nom
inal
ran
ge. V
alue
s of
blo
od p
ress
ure
mea
sure
men
t res
ults
out
side
the
nom
inal
ran
ge o
f cu
ff p
ress
ure
shal
l be
clea
rly
indi
cate
d as
out
of
rang
e.
Tes
ting
shal
l be
carr
ied
out b
y vi
sual
insp
ectio
n.
Def
init
ion
(Int
erna
tiona
l voc
abul
ary
of b
asic
and
gen
eral
term
s in
met
rolo
gy; I
EC
, ISO
, OIM
L, .
..):
nom
inal
ran
ge:
rang
e of
indi
catio
n ob
tain
able
with
a p
artic
ular
set
tings
of
the
cont
rols
of
a m
easu
ring
in
stru
men
t
mea
suri
ng r
ange
:se
t of
valu
es o
f m
easu
rand
sfo
r w
hich
the
erro
r of
a m
easu
ring
inst
rum
ent i
s in
tend
ed to
lie
with
in s
peci
fied
lim
its
6.8.
2 D
igita
l ind
icat
ion
The
dig
ital s
cale
inte
rval
sha
ll be
0.1
kPa
(1
mm
Hg)
. If
the
mea
sure
d va
lue
of a
par
amet
er is
to b
e in
dica
ted
on m
ore
than
one
dis
play
, all
the
disp
lays
sha
ll in
dica
te th
e sa
me
num
eric
al v
alue
.M
easu
red
num
eric
al v
alue
s on
the
disp
lay(
s), a
nd th
e sy
mbo
ls d
efin
ing
the
units
of
mea
sure
men
t sha
ll be
arra
nged
in s
uch
a w
ay s
o as
to a
void
mis
inte
rpre
tatio
n. N
umbe
rsan
d ch
arac
ters
sho
uld
be c
lear
ly le
gibl
e.
Tes
ting
shal
l be
carr
ied
out b
y vi
sual
insp
ectio
n.
24
6.9
Sign
al in
put
and
outp
ut p
orts
The
con
stru
ctio
n of
the
sign
al in
put a
nd o
utpu
t por
ts (
excl
udin
gin
tern
al in
terf
aces
, e.g
.
mic
roph
one
sign
alin
put)
rel
evan
t to
the
non-
inva
sive
blo
od p
ress
ure
mea
sure
men
t sha
ll
ensu
re th
at in
corr
ectly
fitt
ed o
rde
fect
ive
acce
ssor
ies
shal
l not
res
ult i
n er
rone
ous
indi
catio
n
of c
uff
pres
sure
or
erro
neou
s in
dica
tion
ofbl
ood
pres
sure
.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.1
3.
6.10
Ala
rms
If a
larm
s ar
e us
ed th
ey s
hall
be o
f at
leas
t med
ium
pri
ority
.
6.11
Saf
ety
6.11
.1 C
uff p
ress
ure
It s
hall
be p
ossi
ble
to a
bort
any
blo
od p
ress
ure
mea
sure
men
t at a
ny ti
me
by s
ingl
e ke
y op
erat
ion
and
this
sha
ll le
ad to
a r
apid
exh
aust
(se
e 6.
5.3)
.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.1
4.
A.1
4 T
est
met
hod
for
the
cuff
pre
ssur
e de
flat
ion
follo
win
g an
abo
rted
mea
sure
men
t
A.1
4.1
App
arat
us
•ca
libra
ted
refe
renc
e m
anom
eter
with
an
unce
rtai
nty
less
than
0.1
kPa
(0.
8 m
mH
g);
•T
-pie
ce c
onne
ctor
s.
A.1
4.2
Pro
cedu
re a
nd e
valu
atio
n
Inse
rt th
e ca
libra
ted
refe
renc
e m
anom
eter
into
the
pneu
mat
ic s
yste
m b
y m
eans
of
a T
-pie
ce. S
tart
a b
lood
pres
sure
mea
sure
men
t. A
bort
the
mea
sure
men
t dur
ing
infl
atio
n. S
tart
ano
ther
mea
sure
men
t and
abo
rt it
duri
ng th
e pr
essu
re r
educ
tion.
If
inte
rval
mea
sure
men
ts a
re p
ossi
ble
repe
at th
e te
st in
this
mod
e. C
heck
by v
isua
l ins
pect
ion
whe
ther
the
rapi
d ex
haus
t (6.
5.3)
is a
ctiv
ated
.
6.11
.2 U
naut
hori
zed
acce
ss
All
cont
rols
whi
ch a
ffec
t acc
urac
y sh
all b
e se
aled
aga
inst
una
utho
rize
d ac
cess
.
Tes
ting
shal
l be
carr
ied
out b
y vi
sual
insp
ectio
n.
6.11
.3 T
ubin
g co
nnec
tors
Use
rs o
f eq
uipm
ent i
nten
ded
for
use
in e
nvir
onm
ents
em
ploy
ing
inte
rvas
cula
rfl
uid
syst
ems
shal
l tak
e al
lnec
essa
ry p
reca
utio
ns to
avo
id c
onne
ctin
g th
e ou
tput
of
the
bloo
d pr
essu
re
mea
suri
ng d
evic
e to
suc
h sy
stem
sas
air
mig
ht in
adve
rten
tly b
e pu
mpe
d in
to a
blo
od v
esse
l if,
for
exam
ple,
Lue
rlo
cks
wer
e us
ed.
6.11
.4 E
lect
rica
l saf
ety
Ele
ctro
nic
or a
utom
ated
sph
ygm
oman
omet
ers
shal
l com
ply
with
the
rele
vant
nat
iona
l saf
ety
regu
latio
ns.
6.11
.5 R
esis
tanc
e to
vib
ratio
n an
d sh
ock
The
sph
ygm
oman
omet
er s
hall
com
ply
with
the
rele
vant
pro
visi
ons
of O
IML
D 1
1 (e
.g.
subc
laus
eA
.2.2
of th
e 19
94 e
ditio
n, M
echa
nica
l con
ditio
ns).
Aft
er te
stin
g, th
e de
vice
sha
ll
com
ply
with
the
requ
irem
ents
of 5
.1 (
of th
is R
ecom
men
datio
n).
25
AP
EC
/AP
LM
F T
rain
ing
Cou
rses
in L
egal
Met
rolo
gy
(CT
I-11
/200
6T)
Sem
inar
on
Aut
omat
ed S
phyg
mom
anom
eter
s
OIM
L R
16-
2 “N
on-i
nvas
ive
Sphy
gmom
anom
eter
”
Step
han
Mie
kePh
ysik
alis
ch-T
echn
isch
e B
unde
sans
talt
Ber
lin
Ove
rvie
w:
•M
edic
al b
ackg
roun
d
•T
echn
ique
s to
mea
sure
indi
rect
ly th
e bl
ood
pres
sure
•R
equi
rem
ents
, Sta
ndar
ds e
tc. f
or s
phyg
mom
anom
eter
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(pa
ttern
app
rova
l)
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(ve
rifi
catio
n)
7.2
Ver
ific
atio
n
7.2.
1 In
itial
ver
ifica
tion
At i
nitia
l ver
ific
atio
n th
e re
quir
emen
ts o
f 5.
1 (M
ax. p
erm
issi
ble
erro
r of
the
cuff
pre
ssur
e in
dica
tion)
and
6.5.
1 (A
ir le
akag
e))
shal
l be
fulf
illed
.
Tes
ting
shal
l be
carr
ied
out a
ccor
ding
to A
.2 a
nd A
.6.
7.2.
2 Su
bseq
uent
ver
ifica
tion
Eac
h in
stru
men
t of
an a
ppro
ved
type
of
sphy
gmom
anom
eter
sha
ll be
veri
fied
eve
ry 2
yea
rs o
r af
ter
repa
ir. A
t lea
st 5
.1 a
nd 6
.5.1
sha
ll be
ful
fille
d an
d te
sts
mus
tbe
carr
ied
out a
ccor
ding
to A
.2 a
nd A
.6.
7.3
Seal
ing
7.3.
1 C
ontr
ol m
arks
will
be
put o
n le
ad s
eals
for
whi
ch c
orre
spon
ding
pun
ched
scr
ews
shal
l be
atta
ched
whe
neve
r ne
cess
ary.
The
se s
eals
sha
ll pr
even
t, w
ithou
t des
truc
tion
of th
e co
ntro
l mar
ks:
•in
the
case
of
patie
nt-m
onito
rs in
whi
ch th
e sp
hygm
oman
omet
er is
one
par
t of
a sy
stem
: the
man
ipul
atio
n of
the
met
rolo
gica
llyre
leva
nt p
arts
for
mea
suri
ng b
lood
pre
ssur
e;•
in th
e ca
se o
f al
l oth
er m
anom
eter
s: th
e op
enin
g of
the
casi
ng.
7.3.
2 If
the
cons
truc
tion
of th
e in
stru
men
t gua
rant
ees
secu
rity
aga
inst
any
inte
rfer
ence
, the
met
rolo
gica
lco
ntro
l mar
ks o
r th
e se
curi
ty m
arks
may
be
atta
ched
in th
e fo
rm o
f la
bels
.
7.3.
3 A
ll se
als
shal
l be
acce
ssib
le w
ithou
t usi
ng a
tool
.
4 U
nits
of
mea
sure
men
t
The
blo
od p
ress
ure
shal
l be
indi
cate
d ei
ther
in k
ilopa
scal
s (k
Pa)
or in
mill
imet
ers
of m
ercu
ry
(mm
Hg)
.
5 M
etro
logi
cal r
equi
rem
ents
5.1
Max
imum
per
mis
sibl
e er
rors
of
the
cuff
pre
ssur
e in
dica
tion
For
any
set o
f co
nditi
ons
with
in th
e am
bien
t tem
pera
ture
ran
ge o
f 15
°C
to 2
5 °C
and
the
rela
tive
hum
idity
ran
ge o
f 20
% to
85
%, b
oth
for
incr
easi
ng a
ndfo
r de
crea
sing
pre
ssur
e, th
e
max
imum
per
mis
sibl
e er
ror
for
the
mea
sure
men
t of
the
cuff
pre
ssur
e at
any
poi
nt o
f th
e sc
ale
rang
e sh
all b
e ±
0.4
kPa
(±3
mm
Hg)
in c
ase
ofve
rify
ing
the
firs
t tim
e an
d ±
0.5
kPa
(±4
mm
Hg)
for
sph
ygm
oman
omet
ers
in u
se.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
A.2
.
26
A.1
Gen
eral
For
digi
tal i
ndic
atio
ns a
n un
cert
aint
y of
0.1
kPa
(1
mm
Hg)
sha
llbe
allo
wed
in a
ny d
ispl
ayed
val
ue,b
ecau
se
the
disp
lay
syst
em c
anno
t ind
icat
e a
chan
ge o
f le
ss th
an o
ne u
nit.
A.2
Met
hod
of t
est
for
the
max
imum
per
mis
sibl
e er
rors
of
the
cuff
pre
ssur
e in
dica
tion
Req
uire
men
ts in
5.1
sha
ll ap
ply.
A.2
.1 A
ppar
atus
•ri
gid
met
al v
esse
l with
a c
apac
ity o
f 50
0 m
l ±5
%;
•ca
libra
ted
refe
renc
e m
anom
eter
with
an
unce
rtai
nty
less
than
0.1
kPa
(0.
8 m
mH
g);
•pr
essu
re g
ener
ator
, e.g
. bal
l pum
p (h
and
pum
p) w
ith a
def
latio
nva
lve;
•T
-pie
ce c
onne
ctor
s an
d ho
ses.
A.2
.2 P
roce
dure
Rep
lace
the
cuff
with
the
vess
el. C
onne
ct th
e ca
libra
ted
refe
renc
e m
anom
eter
by
mea
ns o
f a
T-p
iece
co
nnec
tor
and
hose
s to
the
pneu
mat
ic c
ircu
it (s
ee F
igur
e 1)
. Aft
er d
isab
ling
the
elec
tro-
mec
hani
cal p
ump
(if
fitte
d),c
onne
ct th
e ad
ditio
nal p
ress
ure
gene
rato
r in
to th
e pr
essu
re s
yste
m b
y m
eans
of
anot
her
T-p
iece
co
nnec
tor.
Car
ry o
ut th
e te
st in
pre
ssur
e st
eps
of n
ot m
ore
than
7 kP
a (5
0 m
mH
g) b
etw
een
0 kP
a (0
mm
Hg)
an
d th
e m
axim
um p
ress
ure
of th
e sc
ale
rang
e.*
*In
case
of
doub
t abo
ut th
e lin
eari
ty, s
pot c
heck
s sh
ould
be
carr
ied
out o
r th
e w
idth
of
the
pres
sure
ste
ps s
houl
d be
red
uced
,i.e
., fr
om th
e no
rmal
ly r
ecom
men
ded
7 kP
a (5
0 m
mH
g) to
3 k
Pa (
20m
mH
g). T
his
also
app
lies
to T
able
1 in
Ann
ex B
.
A.2
.3 E
xpre
ssio
n of
res
ults
Exp
ress
the
resu
lts a
s th
e di
ffer
ence
s be
twee
n th
e in
dica
ted
pres
sure
of
the
man
omet
er o
f th
e de
vice
to b
ete
sted
and
the
corr
espo
ndin
g re
adin
gs o
f th
e re
fere
nce
man
omet
er(s
ee B
.2).
1 -
Ref
eren
ce m
anom
eter
2 -
Dev
ice
to b
e te
sted
3 -
Met
al v
esse
l4
-Pr
essu
re g
ener
ator
Fig
ure
1M
easu
rem
ent s
yste
m f
or d
eter
min
ing
the
limits
of
erro
r of
the
cuff
pre
ssur
e in
dica
tion
Fig
ure:
Mea
sure
men
t se
tup
to d
eter
min
e th
e lim
its
of e
rror
of
the
cuff
pre
ssur
e in
dica
tion
(hom
e us
e de
vice
, pl
ease
not
e: t
he p
ress
ure
is d
ispl
ayed
in t
he s
ysto
lic a
nd d
iast
olic
fie
ld)
Ove
rvie
w:
•M
edic
al b
ackg
roun
d
•T
echn
ique
s to
mea
sure
indi
rect
ly th
e bl
ood
pres
sure
•R
equi
rem
ents
, Sta
ndar
ds e
tc. f
or s
phyg
mom
anom
eter
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(pa
ttern
app
rova
l)
•R
equi
rem
ents
for
aut
omat
ed s
phyg
mom
anom
eter
(ve
rifi
catio
n)
27
7.2
Ver
ific
atio
n
7.2.
1 In
itial
ver
ifica
tion
At i
nitia
l ver
ific
atio
n th
e re
quir
emen
ts o
f 5.
1 (M
ax. p
erm
issi
ble
erro
r of
the
cuff
pre
ssur
e in
dica
tion)
and
6.
5.1
(Air
leak
age)
) sh
all b
e fu
lfill
ed.
Tes
ting
shal
l be
carr
ied
out a
ccor
ding
to A
.2 a
nd A
.6.
7.2.
2 Su
bseq
uent
ver
ifica
tion
Eac
h in
stru
men
t of
an a
ppro
ved
type
of
sphy
gmom
anom
eter
sha
ll be
veri
fied
eve
ry 2
yea
rs o
r af
ter
repa
ir. A
t lea
st 5
.1 a
nd 6
.5.1
sha
ll be
ful
fille
d an
d te
sts
mus
tbe
carr
ied
out a
ccor
ding
to A
.2 a
nd A
.6.
7.3
Seal
ing
7.3.
1 C
ontr
ol m
arks
will
be
put o
n le
ad s
eals
for
whi
ch c
orre
spon
ding
pun
ched
scr
ews
shal
l be
atta
ched
whe
neve
r ne
cess
ary.
The
se s
eals
sha
ll pr
even
t, w
ithou
t des
truc
tion
of th
e co
ntro
l mar
ks:
•in
the
case
of
patie
nt-m
onito
rs in
whi
ch th
e sp
hygm
oman
omet
er is
one
par
t of
a sy
stem
: the
man
ipul
atio
n of
the
met
rolo
gica
llyre
leva
nt p
arts
for
mea
suri
ng b
lood
pre
ssur
e;
•in
the
case
of
all o
ther
man
omet
ers:
the
open
ing
of th
e ca
sing
.
7.3.
2 If
the
cons
truc
tion
of th
e in
stru
men
t gua
rant
ees
secu
rity
aga
inst
any
inte
rfer
ence
, the
met
rolo
gica
l
cont
rol m
arks
or
the
secu
rity
mar
ks m
ay b
e at
tach
ed in
the
form
of
labe
ls.
7.3.
3 A
ll se
als
shal
l be
acce
ssib
le w
ithou
t usi
ng a
tool
.
Thr
ee e
xam
ples
how
to
ente
r th
e ve
rifi
cati
on m
ode:
Exa
mpl
e 1
and
2:
By
pene
trat
ing
the
plug
dee
per
into
the
conn
ectio
n fo
r ve
rifi
catio
n th
e pr
essu
re tr
ansd
ucer
of
test
ed d
evic
e is
sole
ly c
onne
cted
with
the
refe
renc
e m
anom
eter
.
In it
s no
rmal
con
figu
ratio
n th
e pl
ug is
not
so
deep
in th
e co
nnec
tion,
thus
hav
ing
conn
ectio
n to
the
pres
sure
tran
sduc
er, t
he p
ump
and
the
cont
rol v
alve
s of
the
auto
mat
ed s
phyg
mom
anom
eter
.
Exa
mpl
e 3:
Aft
er r
emov
ing
the
wri
st c
uff
the
valv
e ha
s to
be
switc
hed
to “
c”to
clo
se th
e pn
eum
atic
con
nect
ion
to th
e
cont
rol v
alve
s.
Gen
eral
rem
arks
:
Ver
y of
ten
the
“ST
AR
T”
and
the
“PO
WE
R O
N”
switc
h ha
ve to
pre
ssed
at t
he s
ame
time
to e
nter
the
soft
war
e fo
r ve
rifi
catio
n, u
sual
ly th
e di
spla
y of
the
syst
olic
and
the
dias
tolic
dis
play
sho
w th
e pr
essu
re
para
llel.
Clin
ical
mon
itors
usu
ally
hav
e se
rvic
e m
odes
, tha
t inc
lude
man
omet
er m
ode
appl
icab
le f
or v
erif
icat
ion.
Exa
mpl
e 1
and
2
Con
figu
ratio
n fo
r no
rmal
use
Exa
mpl
e 1
and
2
Con
figu
ratio
n fo
r no
rmal
use
, dis
conn
ecte
d pl
ug
28
Exa
mpl
e 1
and
2
Con
figu
ratio
n fo
r no
rmal
use
, dis
conn
ecte
d pl
ug;
uppe
r pa
rt: r
emov
ed s
pace
r, d
owne
r pa
rt: t
urne
d pl
ug
Exa
mpl
e 1
and
2
Con
figu
ratio
n fo
r ve
rifi
catio
n
Exa
mpl
e 3
The
val
ve h
as to
be
turn
ed in
the
posi
ton
c (c
lose
) fo
r ve
rifi
catio
n an
d af
ter
veri
fica
tion
back
to o
(op
en)
for
norm
al u
se
Exa
mpl
e 3
29
AP
EC
/AP
LM
F T
rain
ing
Cou
rses
in L
egal
Met
rolo
gy
(CT
I-11
/200
6T)
Sem
inar
on
Aut
omat
ed S
phyg
mom
anom
eter
s
“Dif
fere
nce
betw
een
OIM
L R
16-2
and
EN
106
0”
Step
han
Mie
kePh
ysik
alis
ch-T
echn
isch
e B
unde
sans
talt
Ber
lin
OIM
L R
16-2
, 5 M
etro
logi
cal r
equi
rem
ents
5.1
Max
imum
per
mis
sibl
e er
rors
of
the
cuff
pre
ssur
e in
dica
tion
For
any
set o
f co
nditi
ons
with
in th
e am
bien
t tem
pera
ture
ran
ge o
f 15
°C
to 2
5 °C
and
the
rela
tive
hum
idity
ran
ge o
f 20
% to
85
%, b
oth
for
incr
easi
ng a
nd f
or d
ecre
asin
g pr
essu
re, t
he m
axim
um
perm
issi
ble
erro
r fo
r th
e m
easu
rem
ent o
f th
e cu
ff p
ress
ure
at a
ny p
oint
of
the
scal
e ra
nge
shal
l be
±0.
4 kP
a (±
3 m
mH
g) in
cas
eof
veri
fyin
g th
e fi
rst t
ime
and
±0.
5 kP
a (±
4 m
mH
g) f
or
sphy
gmom
anom
eter
s in
use
.
EN
106
0, P
art
1, 7
.1 P
erfo
rman
ce
7.1.
1Li
mits
of t
he e
rror
of t
he c
uff p
ress
ure
indi
catio
n
At a
ny s
ingl
e co
nditi
on w
ithin
the
ambi
ent t
empe
ratu
re r
ange
of
15
C to
25
C a
nd th
e
rela
tive
hum
idity
ran
ge o
f 20
% to
85
%‚
both
for
incr
easi
ng a
nd f
or d
ecre
asin
g pr
essu
re, t
he
max
imum
err
or f
or th
e m
easu
rem
ent o
f th
e cu
ff p
ress
ure
at a
ny p
oint
of
the
scal
e ra
nge
shal
l be
3 m
mH
g (
0,4
kPa)
.
OIM
L R
16-2
,5.3
.2 T
empe
ratu
re, r
elat
ive
hum
idity
For
the
ambi
ent t
empe
ratu
re r
ange
of
10 °
C to
40
°C a
nd a
rel
ativ
e hu
mid
ity o
f 85
% (
non-
cond
ensi
ng),
the
diff
eren
ce o
f th
e cu
ff p
ress
ure
indi
catio
n of
the
sphy
gmom
anom
eter
sha
ll no
t
exce
ed ±
0.4
kPa
(±3
mm
Hg)
.
The
sig
nal p
roce
ssin
g fo
r th
e de
term
inat
ion
of th
e bl
ood
pres
sure
val
ues
shal
l not
be
infl
uenc
ed
with
inth
e ra
nge
of te
mpe
ratu
re a
nd r
elat
ive
hum
idity
.For
any
set
of
cond
ition
s al
l the
dev
iatio
ns
betw
een
the
refe
renc
e pr
essu
re a
nd th
e in
dica
ting
cuff
pre
ssur
e of
the
inst
rum
ent m
ust b
e le
ss
than
or
equa
l to
the
max
imum
per
mis
sibl
e er
ror.
EN
106
0, P
art 1
, 7.1
.2.2
Effe
ct o
f tem
pera
ture
For
the
ambi
ent t
empe
ratu
re r
ange
of
10
C to
40
C a
nd th
e re
lativ
e hu
mid
ity o
f 85
% (
non-
cond
ensi
ng),
the
diff
eren
ce o
f th
e cu
ff p
ress
ure
indi
catio
n of
the
sphy
gmom
anom
eter
sha
ll no
t
exce
ed 3
mm
Hg
(0,4
kPa
).
EN
106
0, P
art 3
, 7.5
.2Te
mpe
ratu
re, r
elat
ive
hum
idity
7.1.
2.2
of E
N 1
060-
1: 1
995
shal
l app
ly.
The
sig
nal p
roce
ssin
g fo
r th
e de
term
inat
ion
of th
e bl
ood
pres
sure
val
ues
shal
l not
be
infl
uenc
ed
with
in th
e ra
nge
of te
mpe
ratu
re a
nd R
elat
ive
Hum
idity
spe
cifi
ed in
7.1
.2.2
of
EN
106
0-1:
199
5.
OIM
L R
16-2
, 6.1
1.3
Tubi
ng c
onne
ctor
s
Use
rs o
f eq
uipm
ent i
nten
ded
for
use
in e
nvir
onm
ents
em
ploy
ing
inte
rvas
cula
rfl
uid
syst
ems
shal
l tak
e al
lnec
essa
ry p
reca
utio
ns to
avo
id c
onne
ctin
g th
e ou
tput
of
the
bloo
d pr
essu
re
mea
suri
ng d
evic
e to
suc
h sy
stem
sas
air
mig
ht in
adve
rten
tly b
e pu
mpe
d in
to a
blo
od v
esse
l
if, f
or e
xam
ple,
Lue
rlo
cks
wer
e us
ed.
EN
106
0, P
art
1, 1
Sco
pe
....
NO
TE
: Thi
s st
anda
rd r
ecom
men
ds th
at L
uer
lock
con
nect
ors
shou
ld n
ot b
e us
ed w
ith th
ese
devi
ces.
Part
3: 7
.11.
3 Tu
bing
con
nect
ors
Lue
rlo
ck c
onne
ctor
s sh
all n
ot b
e us
ed.
NO
TE
: In
orde
r to
avo
id p
ossi
ble
mis
conn
ectio
n w
ith in
trav
ascu
lar
syst
ems
Lue
rsl
ip
conn
ecto
rs s
houl
d no
t be
used
.
30
OIM
L R
16-2
, 5 M
etro
logi
cal c
ontr
ols
7.1
Typ
e ap
prov
al
7.2
Ver
ific
atio
n
EN
106
0: N
o su
ch c
laus
es, b
ecau
se c
over
ed b
y E
urop
ean
Dir
ectiv
e
OIM
L R
16-2
, 5.2
Max
imum
per
mis
sibl
e er
rors
of
the
over
all s
yste
m a
s m
easu
red
by
clin
ical
tes
ts*
(* c
arri
ed o
ut b
y th
e m
anuf
actu
rer)
The
fol
low
ing
max
imum
per
mis
sibl
e er
rors
sha
ll ap
ply
for
the
over
all s
yste
m:
-m
axim
um m
ean
erro
r of
mea
sure
men
t: ±
0.7
kPa
(±5
mm
Hg)
;-
max
imum
exp
erim
enta
l sta
ndar
d de
viat
ion:
1.1
kPa
(8
mm
Hg)
.
For
furt
her
reco
mm
ende
d te
st m
etho
ds s
ee A
nnex
C.
EN
106
0-3:
7.9
Ove
rall
syst
em a
ccur
acy
Exc
ept f
or s
hort
term
aut
omat
ic m
ode
(see
2.1
02 o
f E
N 6
0601
-2-3
0: 1
995)
and
dev
ices
in w
hich
bl
ood
pres
sure
is d
eter
min
ed m
anua
lly w
ith th
e ai
d of
a s
teth
osco
pe, t
he f
ollo
win
g ov
eral
l sys
tem
ac
cura
cy v
alue
s sh
all a
pply
:a)
max
imum
mea
n er
ror
of m
easu
rem
ent:
±
5m
mH
g (±
0,7
kPa)
;b)
max
imum
exp
erim
enta
lsta
ndar
dde
viat
ion:
8m
mH
g(1
,1kP
a).
Tes
ting
shal
l be
perf
orm
ed in
acc
orda
nce
with
EN
106
0-4.
Upo
n re
ques
t the
man
ufac
ture
r sh
all p
rovi
de e
vide
nce
to th
e N
otif
ied
Bod
y th
at th
ese
requ
irem
ents
are
met
.
Rev
ised
in 2
005
Table
1 —
Matr
ix for
the s
ele
ction o
f th
e c
linic
al te
st m
eth
od
Refe
rence
meth
od
Measure
ment te
chniq
ue o
f
the d
evic
e to b
e teste
d
Clinic
al te
st m
eth
od a
s a
function
of application
adults
neonate
l
mode
erg
o.a
AB
PM
b
Con
tinuo
us
pres
sure
dr
op
or
pres
sure
dr
op
in
step
s(u
pper
arm
mea
sure
men
t)
3m
mH
g/s
or
3m
mH
g/pu
lsec
> 3m
mH
g/s
or >
3m
mH
g/pu
lsec
N1/
N2/
N3
N2/
N3
- -
N4 -
N5/
N6
N6
Mea
sure
men
t on
othe
r site
s th
an th
e up
per a
rmN
2/N
3
Aus
culta
tory
mea
sure
men
tat
th
e up
per
arm
Mea
sure
men
t dur
ing
infla
tion
phas
eN
2/N
3-
-N
6
Inva
sive
mea
sure
men
tM
easu
rem
ent d
urin
g th
e pr
essu
re d
rop
or th
e in
flatio
n ph
ase
I 1I 2
--
aE
rgom
etry
(mea
sure
men
t und
er p
hysi
cal l
oad)
bA
mbu
lato
ry b
lood
pre
ssur
e m
easu
rem
ent
cFo
r dev
ices
ada
ptin
g to
the
puls
e ra
te
EN
106
0-4,
4.3
Fig:
Clin
ical
test
set
-up
acco
rdin
g E
N 1
060-
4 (N
1) f
or d
evic
es w
ith d
efla
tion
rate
s up
to 3
mm
Hg/
s.
31
Fig.
:Clin
ical
test
set
-up
acco
rdin
g E
N 1
060-
4 (N
3) f
or d
evic
es w
ith d
efla
tion
rate
s hi
gher
than
3 m
mH
g/s
(seq
uent
ial m
easu
rem
ent)
.
32
AP
EC
/AP
LM
F T
rain
ing
Cou
rses
in L
egal
Met
rolo
gy
(CT
I-11
/200
6T)
Sem
inar
on
Aut
omat
ed S
phyg
mom
anom
eter
s
“The
tra
ceab
ility
of
med
ical
dev
ice”
Step
han
Mie
kePh
ysik
alis
ch-T
echn
isch
e B
unde
sans
talt
Ber
lin
Cla
ssic
al w
ay (
“har
d m
etro
logy
”):
prim
ary
stan
dard
refe
renc
e st
anda
rd
wor
king
sta
ndar
d
devi
ce
Tra
ceab
ility
of
med
ical
dev
ices
Wha
t is
spec
ial f
or m
edic
al d
evic
es w
ith a
mea
suri
ng f
unct
ion?
Usu
ally
the
mea
sure
men
t is
base
d on
ph
ysio
logic
al
model
s,
e.g.
intr
a-oc
ular
pre
ssur
e. A
ll no
n-in
vasi
ve in
tra-
ocul
ar p
ress
ure
mea
sure
-men
tsar
e ba
sed
on a
com
para
tive
stud
y of
dir
ect a
nd in
dire
ct
mea
sure
men
ts o
n ap
prox
imat
ely
10 e
yes
of d
ead
peop
le p
erfo
rmed
once
by
Han
s G
oldm
ann
in S
witz
erla
nd in
195
5. T
he r
esul
ts w
ere
adop
ted
by th
e m
edic
al c
omm
unity
and
bec
ame
the
"gol
d st
anda
rd"
to
this
day
for
this
kin
d of
mea
sure
men
t.
Tra
ceab
ility
of
med
ical
dev
ices
“Sof
t met
rolo
gy":
Prob
lem
:in
tra-
indi
vidu
al a
nd in
ter-
indi
vidu
al v
aria
tions
How
the
prob
lem
is a
ddre
ssed
:m
etro
logy
bas
ed o
n
>ac
cept
ed d
iagn
ostic
/ther
apeu
tic li
mits
(so
ft I
),
>da
taba
se o
f cl
inic
al d
ata
for
gen
eral
appl
icat
ion
(sof
t II)
,
>in
divi
dual
clin
ical
tria
l for
a s
pec
ific
devi
ce (
soft
III
)
Tra
ceab
ility
of
med
ical
dev
ices
33
Tra
ceab
ility
of
med
ical
dev
ices
soft
met
rolo
gyha
rdm
etro
logy
soft
Iso
ft I
Iso
ft I
II
prim
ary
stan
dard
prim
ary
stan
dard
data
base
of t
est
sign
als
one
clin
ical
lyte
sted
devi
ce
refe
renc
est
anda
rdre
fere
nce
stan
dard
wor
king
stan
dard
wor
king
stan
dard
test
devi
ce/g
ener
ator
tran
sfer
stan
dard
devi
cede
vice
devi
cede
vice
Tra
ceab
ility
of
med
ical
dev
ices
soft
met
rolo
gyha
rdm
etro
logy
soft
Iso
ft I
Iso
ft I
II
prim
ary
stan
dard
prim
ary
stan
dard
data
base
of t
est
sign
als
one
clin
ical
lyte
sted
devi
ce
refe
renc
est
anda
rdre
fere
nce
stan
dard
wor
king
stan
dard
wor
king
stan
dard
test
devi
ce/g
ener
ator
tran
sfer
stan
dard
devi
cede
vice
devi
cede
vice
wor
king
sta
ndar
d: w
ater
bat
hre
fere
nce
stan
dard
: cal
ibra
ted
ther
mom
eter
prim
ary
stan
dard
: int
erna
tiona
l tem
pera
ture
sca
le (
ITS
90)
Med
ical
dev
ice:
liqui
d-in
-gla
ss th
erm
omet
er,
elec
tric
al th
erm
omet
er
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
Med
ical
dev
ice:
infr
a-re
d ea
r th
erm
omet
er
wor
king
sta
ndar
d: r
efer
ence
bat
h bl
ack
body
rad
iato
r re
fere
nce
stan
dard
: cal
ibra
ted
ther
mom
eter
prim
ary
stan
dard
: int
erna
tiona
l tem
pera
ture
sca
le (
ITS
90)
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
34
Med
ical
dev
ice:
sphy
gmom
anom
eter
wor
king
sta
ndar
d: c
alib
rate
d pr
essu
re m
eter
refe
renc
e st
anda
rd: p
ress
ure
bala
nce
prim
ary
stan
dard
: PT
B s
tand
ards
for
for
ce a
nd le
ngth
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
wor
king
sta
ndar
d: c
alib
rato
rre
fere
nce
stan
dard
: PT
B s
tand
ard
for
dyna
mic
rot
ator
ypo
wer
prim
ary
stan
dard
: PT
B s
tand
ards
for
torq
ue, l
engt
h, ti
me
Med
ical
dev
ice:
ergo
met
er
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
Tra
ceab
ility
of
med
ical
dev
ices
soft
met
rolo
gyha
rdm
etro
logy
soft
Iso
ft I
Iso
ft I
II
prim
ary
stan
dard
prim
ary
stan
dard
data
base
of t
est
sign
als
one
clin
ical
lyte
sted
devi
ce
refe
renc
est
anda
rdre
fere
nce
stan
dard
wor
king
stan
dard
wor
king
stan
dard
test
devi
ce/g
ener
ator
tran
sfer
stan
dard
devi
cede
vice
devi
cede
vice
Med
ical
dev
ice:
peak
exp
irat
ory
flow
met
er
test
gen
erat
or: p
ump
syst
em(c
alib
rate
d by
PT
B s
tand
ard
for
dyna
mic
flo
w)
data
base
of
test
sig
nals
: wav
efor
ms
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
I
35
Tra
ceab
ility
of
med
ical
dev
ices
soft
met
rolo
gyha
rdm
etro
logy
soft
Iso
ft I
Iso
ft I
II
prim
ary
stan
dard
prim
ary
stan
dard
data
base
of t
est
sign
als
one
clin
ical
lyte
sted
devi
ce
refe
renc
est
anda
rdre
fere
nce
stan
dard
wor
king
stan
dard
wor
king
stan
dard
test
devi
ce/g
ener
ator
tran
sfer
stan
dard
devi
cede
vice
devi
cede
vice
Med
ical
dev
ice:
air
puff
eye
tono
met
er
tran
sfer
sta
ndar
d: P
TB
test
dev
ice
(fla
pper
)cl
inic
ally
test
ed m
edic
al d
evic
e:
150
eyes
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
II
Med
ical
dev
ice:
auto
mat
ed s
phyg
mom
anom
eter
tran
sfer
sta
ndar
d: s
oftw
are
vers
ion
for
the
dete
rmin
atio
n of
the
bloo
d pr
essu
re v
alue
scl
inic
ally
test
ed m
edic
al d
evic
e:
85 s
ubje
cts
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
II
New
dev
elop
men
t: E
U p
roje
ct “
Sim
ulat
or f
or n
ibp”
(200
2-20
05)
Subs
titut
ion
of c
linic
al tr
ial b
y da
taba
se o
f va
lidat
ed o
scill
ogra
ms,
at
pre
sent
: > 1
000
sign
als
from
> 6
00 s
ubje
cts
soft
II
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
II
36
Med
ical
dev
ice:
audi
omet
er
tran
sfer
sta
ndar
d: a
rtif
icia
l ear
clin
ical
ly te
sted
med
ical
dev
ice:
he
arin
g th
resh
old
dete
rmin
ed a
t 25
youn
gsu
bjec
ts
Tra
ceab
ility
of
med
ical
dev
ices
: so
ft I
II
Met
rolo
gy f
or m
edic
al d
evic
es w
ith a
mea
suri
ng f
unct
ion
is
diff
eren
t fro
m tr
aditi
onal
met
rolo
gy, b
ecau
se p
hysi
olog
ical
assu
mpt
ions
hav
e to
be
take
n in
to a
ccou
nt in
mos
t cas
es.
Furt
herm
ore
prim
ary
stan
dard
s ar
e no
t alw
ays
avai
labl
e, it
is
nece
ssar
y to
rep
lace
them
by
an a
ccep
ted
data
base
or
by
indi
vidu
ally
clin
ical
ly te
sted
dev
ices
.
Tra
ceab
ility
of
med
ical
dev
ices
: C
oncl
usio
n
PT
B g
roup
topi
c(t
ask)
cont
act
1.6
Med
ical
Aco
ustic
s/U
ltras
ound
(aud
iom
eter
, ultr
asou
ndde
vice
s)C
hris
tian
Koc
h
3.1
Met
rolo
gyin
Che
mis
try
Ber
nd
Güt
tler
6.2
Dos
imet
ryfo
rR
adio
ther
apy
(bra
chyt
hera
py,
alan
ine
dose
met
erpr
obes
)H
ans-
Mic
hael
Kra
mer
7.31
Tem
pera
ture
Rad
iatio
n(i
nfra
-red
ear
ther
mom
eter
)Jö
rg H
olla
ndt
7.42
App
lied
The
rmom
etry
(clin
ical
ther
mom
eter
)E
rich
T
egel
er
8.11
NM
R M
easu
ring
Tec
hniq
ues
(RF
pow
erde
posi
tion
in M
RI)
Fran
k Se
ifer
t / B
ernd
It
term
ann
8.12
Stan
dard
s fo
rM
edic
alM
easu
ring
Tec
hniq
ues
(eye
tono
met
er, s
phyg
mom
anom
eter
,er
gom
eter
, sp
irom
eter
)
Step
han
Mie
ke
8.32
Flow
Cyt
omet
ryan
d M
icro
scop
y(f
ullb
lood
coun
t)Jö
rg N
euka
mm
er
Tra
ceab
ility
of
med
ical
dev
ices
: PT
B a
ctiv
ities
Tha
nk y
ou !
37
AP
EC
/AP
LM
F T
rain
ing
Cou
rses
in L
egal
Met
rolo
gy
(CT
I-11
/200
6T)
Sem
inar
on
Aut
omat
ed S
phyg
mom
anom
eter
s
“Eur
opea
n St
anda
rds
on S
phyg
mom
anom
eter
s”
Step
han
Mie
kePh
ysik
alis
ch-T
echn
isch
e B
unde
sans
talt
Ber
lin
EN
106
0 N
on-i
nvas
ive
sphy
gmom
anom
eter
s
•E
N 1
060-
1 G
ener
al r
equi
rem
ents
(19
95)
•E
N 1
060-
2 Su
pple
men
tary
req
uire
men
ts f
or m
echa
nica
l
sphy
gmom
anom
eter
s (1
995)
•E
N 1
060-
3 Su
pple
men
tary
req
uire
men
ts f
or e
lect
ro-m
echa
nica
l
bloo
d pr
essu
re m
easu
ring
sys
tem
s (
1997
/ 20
05)
•E
N 1
060-
4 T
est p
roce
dure
s to
det
erm
ine
the
over
all s
yste
m
accu
racy
of
auto
mat
ed n
on-i
nvas
ive
sphy
gmom
anom
eter
s
(200
4)
EN
106
0 :S
truc
ture
non-
auto
mat
edsp
hygm
oman
omet
ere.
g. w
ith H
g-, a
nero
id-m
anom
eter
auto
mat
edsp
hygm
oman
omet
ere.
g. h
ome-
use,
clin
ical
dev
ice
EN
106
0-2
EN
106
0-1
EN
106
0-3
EN
106
0-4
EN
106
0 :S
truc
ture
EN
106
0 N
on-i
nvas
ive
sphy
gmom
anom
eter
s
•E
N 1
060-
1 G
ener
al r
equi
rem
ents
(19
95)
•E
N 1
060-
2 Su
pple
men
tary
req
uire
men
ts f
or m
echa
nica
l
sphy
gmom
anom
eter
s (1
995)
•E
N 1
060-
3 Su
pple
men
tary
req
uire
men
ts f
or e
lect
ro-m
echa
nica
l
bloo
d pr
essu
re m
easu
ring
sys
tem
s (
1997
/ 20
05)
•E
N 1
060-
4 T
est p
roce
dure
s to
det
erm
ine
the
over
all s
yste
m
accu
racy
of
auto
mat
ed n
on-i
nvas
ive
sphy
gmom
anom
eter
s
(200
4)
EN
106
0 :P
art 1
38
4 C
uff
The
cuf
f sh
all c
onta
in a
bla
dder
. For
reu
sabl
e cu
ffs
the
man
ufac
ture
r
shal
l ind
icat
e th
e m
etho
d fo
r cl
eani
ng in
the
acco
mpa
nyin
g
docu
men
ts (
see
9.2)
.
NO
TE
:The
Opt
imum
bla
dder
siz
e is
one
with
dim
ensi
ons
such
that
its w
idth
is 4
0 %
of
the
limb
circ
umfe
renc
eat
the
cent
re o
f th
e ra
nge
for
each
cuf
f si
ze a
nd th
at it
s le
ngth
is 8
0 %
to 1
00 %
of
the
limb
circ
umfe
renc
eat
the
cent
re o
f th
e ra
nge
for
each
cuf
f si
ze. U
se o
f th
e
wro
ng s
ize
can
affe
ct th
e ac
cura
cy o
f th
e m
easu
rem
ent.
The
se
reco
mm
ende
d di
men
sion
s ar
e su
bjec
t to
ongo
ing
cons
ider
atio
n.
EN
106
0 :P
art 1
5D
ispl
ay
The
dis
play
sha
ll be
des
igne
d an
d ar
rang
ed s
o th
at th
e in
form
atio
n in
clud
ing
mea
suri
ng v
alue
s ca
n be
rea
d an
d ea
sily
rec
ogni
zed.
Tes
ting
shal
l be
carr
ied
out b
y vi
sual
insp
ectio
n.
If a
bbre
viat
ions
are
used
on
the
disp
lay
they
sha
ll be
as
follo
ws:
”S”
or ”
SYS‘
t : s
ysto
lic b
lood
pre
ssur
e (v
alue
);”D
”or
”D
IA”:
di
asto
lic b
lood
pre
ssur
e (v
alue
);or
”M
AP”
:
m
ean
arte
rial
blo
od p
ress
ure
(val
ue).
Sing
le le
tter
abbr
evia
tions
sha
ll be
pos
ition
ed in
suc
h a
way
toav
oid
conf
usio
n w
ith S
I un
its.
6 U
nits
The
blo
od p
ress
ure
shal
l be
indi
cate
d in
eith
er m
illim
etre
sof
mer
cury
(mm
Hg)
or
kilo
pasc
als
(kPa
).
EN
106
0 :P
art 1
7.1.
1Li
mits
of t
he e
rror
of t
he c
uff p
ress
ure
indi
catio
n
At a
ny s
ingl
e co
nditi
on w
ithin
the
ambi
ent t
empe
ratu
re r
ange
of
15 °
C to
25
°Can
d th
e re
lativ
e hu
mid
ity r
ange
of
20 %
to 8
5 %
‚bo
th f
or in
crea
sing
and
for
de
crea
sing
pre
ssur
e, th
e m
axim
um e
rror
for
the
mea
sure
men
t of
the
cuff
pre
ssur
e at
any
poi
nt o
f th
e sc
ale
rang
esh
all b
e ±
3 m
mH
g(±
0,4
kPa)
.
8.1
Met
hod
of te
st f
or th
e lim
its o
f er
ror
of th
e cu
ff p
ress
ure
indi
catio
n8.
1.1
App
arat
usa)
rig
id m
etal
ves
sel w
ith a
cap
acity
of
500
ml ±
5 %
;b)
cal
ibra
ted
refe
renc
e m
anom
eter
with
an
erro
r le
ss th
an 0
,8 m
m/H
g (0
,1 k
Pa);
... 8.1.
2P
roce
dure
... b) C
arry
out
the
test
in p
ress
ure
step
s of
not
mor
e th
an 5
0 m
mH
gbe
twee
n0
mm
Hg
and
the
max
imum
pre
ssur
e of
the
scal
e ra
nge.
EN
106
0 :P
art 1
1 -
Ref
eren
ce m
anom
eter
2 -
Man
omet
er o
f th
e de
vice
to b
e te
sted
3 -
Met
al v
esse
l4
-Pr
essu
re g
ener
ator
Fig
ure:
Tes
t ri
g fo
r de
term
inin
g th
e lim
its
of e
rror
of
the
cuff
pres
sure
indi
cati
on
EN
106
0 :P
art 1
39
Fig
ure:
Mea
sure
men
t se
tup
to d
eter
min
e th
e lim
its
of e
rror
of
the
cuff
pre
ssur
e in
dica
tion
(ho
me
use
devi
ce)
EN
106
0 :P
art 1
7.1.
2E
nvir
onm
enta
l per
form
ance
7.1.
2.1
Effe
ct o
f sto
rage
The
sph
ygm
oman
omet
er s
hall
mai
ntai
n th
e re
quir
emen
ts s
peci
fied
in
this
sta
ndar
d af
ter
stor
age
for
24 h
at a
tem
pera
ture
of
-20
°C a
nd
for
24 h
at a
tem
pera
ture
of
70 °
C a
nd a
rel
ativ
e hu
mid
ity o
f 85
%(n
on-c
onde
nsin
g).
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
8.1
at e
nvir
onm
enta
l co
nditi
ons
desc
ribe
d in
7.1
.1 a
fter
the
test
sam
ple
has
been
pla
ced
for
24 h
at a
tem
pera
ture
of
-20
°C a
nd im
med
iate
lyaf
terw
ards
for
24
h at
a te
mpe
ratu
re o
f 70
°C
in a
clim
atic
cha
mbe
r.
EN
106
0 :P
art 1
7.1.
2E
nvir
onm
enta
l per
form
ance
7.1.
2.2
Effe
ct o
f tem
pera
ture
For
the
ambi
ent t
empe
ratu
re r
ange
of
10 °
C to
40
°Can
d th
e re
lativ
e
hum
idity
of
85 %
(no
n-co
nden
sing
), th
e di
ffer
ence
of
the
cuff
pres
sure
indi
catio
nof
the
sphy
gmom
anom
eter
sha
ll no
t exc
eed
3
mm
Hg
(0,4
kPa
).
EN
106
0 :P
art 1
1 -
Ref
eren
ce m
anom
eter
2
-C
limat
ic c
ham
ber
3 -
Dev
ice
to b
e te
sted
4 -
Met
al v
esse
l5
-Pr
essu
re g
ener
ator
Fig
ure:
Mea
sure
men
t sys
tem
for
det
erm
inin
g th
e in
flue
nce
of te
mpe
ratu
re
EN
106
0 :P
art 1
40
EN
106
0 N
on-i
nvas
ive
sphy
gmom
anom
eter
s
•E
N 1
060-
1 G
ener
al r
equi
rem
ents
(19
95)
•E
N 1
060-
2 Su
pple
men
tary
req
uire
men
ts f
or m
echa
nica
l
sphy
gmom
anom
eter
s (1
995)
•E
N 1
060-
3 Su
pple
men
tary
req
uire
men
ts f
or e
lect
ro-m
echa
nica
l
bloo
d pr
essu
re m
easu
ring
sys
tem
s (
1997
/ 20
05)
•E
N 1
060-
4 T
est p
roce
dure
s to
det
erm
ine
the
over
all s
yste
m
accu
racy
of
auto
mat
ed n
on-i
nvas
ive
sphy
gmom
anom
eter
s
(200
4)
EN
106
0 :P
art 2
7.1.
3.1
Air
leak
age
Air
leak
age
shal
l not
exc
eed
a pr
essu
re d
rop
of 4
mm
Hg/
min
(0,
5 kP
a/m
in).
7.1.
3.2
Pre
ssur
e re
duct
ion
rate
Man
ually
ope
rate
d an
d se
lf-l
inea
rizi
ngde
flat
ion
valv
essh
all b
e ca
pabl
e of
adj
ustm
ent t
o a
defl
atio
n ra
te o
f (2
to 3
) m
mH
g/s
((0,
3 to
0,
4) k
Pa/s
).
Man
ually
ope
rate
d de
flat
ion
valv
es s
hall
be e
asily
adj
uste
dto
thes
e va
lues
.
Self
-lin
eari
zing
valv
es s
hall
be te
sted
in a
ccor
danc
e w
ith 8
.2.
EN
106
0 :P
art 2
7.2.
3M
echa
nica
l saf
ety
It s
hall
be p
ossi
ble
to a
bort
the
bloo
d pr
essu
re m
easu
rem
ent a
t any
time
by a
ctiv
atin
g th
e m
anua
l rap
id e
xhau
st v
alve
, whi
ch s
hall
be
easi
ly a
cces
sibl
e.
7.2.
4Ta
mpe
r pr
oofin
g
Tam
per
proo
fing
of
the
man
omet
er s
hall
be a
chie
ved
by r
equi
ring
the
use
of a
tool
or
the
brea
king
of
a se
al.
EN
106
0 :P
art 2
7.3
Add
itio
nal r
equi
rem
ents
for
mer
cury
man
omet
er
7.3.
1In
tern
al d
iam
eter
of t
he tu
be c
onta
inin
g m
ercu
ry
The
nom
inal
inte
rnal
dia
met
er o
f th
e tu
beco
ntai
ning
mer
cury
sha
ll be
at
leas
t 3,5
mm
. The
tole
ranc
e on
dia
met
er s
hall
not e
xcee
d ±
0,2
mm
. (S
ee a
lso
9.3b
)).
7.3.
2P
orta
ble
devi
ces
A p
orta
ble
devi
ce s
hall
be p
rovi
ded
with
an
adju
stin
g or
lock
ing
mec
hani
smto
sec
ure
it in
the
spec
ifie
d po
sitio
n fo
r us
e.
EN
106
0 :P
art 2
41
7.3.
3Tu
be c
onta
inin
g m
ercu
ry a
nd r
eser
voir
A lo
ckin
g de
vice
shal
l be
plac
ed b
etw
een
the
rese
rvoi
r an
d th
e tu
be
to p
reve
nt th
e sp
illag
e of
mer
cury
dur
ing
tran
spor
t.
7.3.
4St
oppi
ng d
evic
e in
the
tube
con
tain
ing
mer
cury
and
res
ervo
ir
A s
topp
ing
devi
ce s
hall
be in
corp
orat
ed in
the
rese
rvoi
r an
d th
etu
be,
whi
ch s
hall
prev
ent t
he m
ercu
ry f
rom
bei
ng s
pille
d du
ring
tran
spor
t
and
use.
The
del
ay in
the
setti
ngof
the
mer
cury
col
umn
due
to th
e
stop
ping
dev
ice
shal
l not
exc
eed
1,5
s fo
r th
e fl
ow o
f th
e m
ercu
ry
from
200
mm
Hg
to 5
0 m
mH
g(f
rom
25
kPa
to 5
kPa
) w
hen
die
pres
sure
in th
e sy
stem
dro
ps r
apid
ly f
rom
200
mm
Hg
to 0
mm
Hg
(fro
m 2
5 kP
a to
0 k
Pa).
EN
106
0 :P
art 2
7.4
Add
itio
nal r
equi
rem
ents
for
ane
roid
man
omet
er
7.4.
1Sc
ale
mar
k at
zer
o
If a
tole
ranc
e zo
ne is
sho
wn
at z
ero
it sh
all n
ot e
xcee
d ±
3 m
mH
g (±
0,4
kPa)
an
d sh
all b
e cl
earl
y m
arke
d.A
sca
le m
ark
at z
ero
shal
l be
indi
cate
d .
NO
TE
:Gra
duat
ions
with
in th
e to
lera
nce
zone
are
opt
iona
l.
7.4.
2Ze
ro
The
mov
emen
t of
the
ela
stic
sen
sing
ele
men
t in
clud
ing
the
poin
ter
shal
l no
t be
obs
truc
ted
with
in 6
mm
Hg
(0,8
kPa
) be
low
zer
o.
Nei
ther
the
dial
nor
the
poin
ter
shal
l be
adju
stab
le b
y th
e us
er.
EN
106
0 :P
art 2
7.4.
4H
yste
resi
ser
ror
The
hys
tere
sis
erro
r th
roug
hout
the
pres
sure
ran
ge s
hall
be w
ithin
the
rang
e 0
mm
Hg
to 4
mm
Hg
(0 k
Pa to
0,5
kPa
).
7.4.
5C
onst
ruct
ion
and
mat
eria
lsT
he c
onst
ruct
ion
of th
e an
eroi
d m
anom
eter
and
the
mat
eria
l for
the
elas
tic s
ensi
ng e
lem
ents
sha
ll en
sure
an
adeq
uate
sta
bilit
y of
the
mea
sure
men
t. T
he e
last
ic s
ensi
ng e
lem
ents
sha
ll be
age
d w
ith
resp
ect t
o pr
essu
re a
nd te
mpe
ratu
re.
The
dif
fere
nce
in th
e pr
essu
re in
dica
tion
of th
e an
eroi
d m
anom
eter
be
fore
and
aft
er10
000
alte
rnat
ing
pres
sure
cyc
les
shal
l be
not m
ore
than
3 m
mH
g (0
,4 k
Pa)
thro
ugho
ut th
e pr
essu
re r
ange
.
EN
106
0 :P
art 2
9 I
nfor
mat
ion
to b
e su
pplie
d by
the
man
ufac
ture
r
9.1
...
9.2
Inst
ruct
ion
leaf
let
Item
s a)
, b)
and
c) o
f su
bcla
use
9.2
of E
N 1
060-
1:19
95 s
hall
appl
y w
ith th
e fo
llow
ing
addi
tion:
a) n
atur
e an
d fr
eque
ncy
of th
e m
aint
enan
ce to
ens
ure
that
the
devi
ce
oper
ates
pro
perl
y an
d sa
fely
at a
ll tim
es;
NO
TE
: It i
s re
com
men
ded
that
the
perf
orm
ance
sho
uld
be c
heck
ed a
t lea
stev
ery
2 y
and
afte
r m
aint
enan
ce a
nd r
epai
r, b
y re
-tes
ting
at le
ast t
he
requ
ire-
men
tsin
7.1
.1, 7
.1.3
.1 (
test
ing
at le
ast a
t 50
mm
Hg
and
200
mm
Hg)
an
d 7.
3.4.
c) in
tern
al n
omin
al d
iam
eter
and
tole
ranc
e of
the
tube
con
tain
ing
mer
cury
; d)
deta
iled
inst
ruct
ions
for
the
safe
han
dlin
g of
mer
cury
(se
e an
nex
B).
EN
106
0 :P
art 2
42
EN
106
0 N
on-i
nvas
ive
sphy
gmom
anom
eter
s
•E
N 1
060-
1 G
ener
al r
equi
rem
ents
(19
95)
•E
N 1
060-
2 Su
pple
men
tary
req
uire
men
ts f
or m
echa
nica
l
sphy
gmom
anom
eter
s (1
995)
•E
N 1
060-
3 Su
pple
men
tary
req
uire
men
ts f
or e
lect
ro-m
echa
nica
l
bloo
d pr
essu
re m
easu
ring
sys
tem
s (
1997
/ 20
05)
•E
N 1
060-
4 T
est p
roce
dure
s to
det
erm
ine
the
over
all s
yste
m
accu
racy
of
auto
mat
ed n
on-i
nvas
ive
sphy
gmom
anom
eter
s
(200
4)
EN
106
0 :P
art 3
1 S
cope
Thi
s Pa
rt o
f E
N 1
060
spec
ifie
s pe
rfor
man
ce, e
ffic
ienc
y an
d sa
fety
re
quir
emen
ts f
or e
lect
ro-m
echa
nica
l blo
od p
ress
ure
mea
suri
ng
syst
ems
that
, by
mea
ns o
f an
infl
atab
le c
uff
are
used
for
non
-inv
asiv
e m
easu
rem
ents
of
arte
rial
blo
od p
ress
ure
at th
e up
per
arm
, the
wri
st
and
the
thig
h. I
t als
o sp
ecif
ies
requ
irem
ents
for
thei
r ac
cess
orie
s an
d gi
ves
test
met
hods
.
Thi
s Pa
rt o
f E
N 1
060
appl
ies
to e
lect
ro-m
echa
nica
l blo
od p
ress
ure
mea
suri
ng s
yste
ms
in w
hich
the
cuff
pre
ssur
e is
mea
sure
d el
ectr
onic
ally
, but
in w
hich
the
bloo
d pr
essu
re c
an b
e de
term
ined
ei
ther
man
ually
with
the
aid
of a
ste
thos
cope
or
auto
mat
ical
ly.
Add
ition
al s
afet
y re
quir
emen
ts f
or a
utom
atic
cyc
ling
indi
rect
blo
od
pres
sure
mon
itori
ng e
quip
men
t are
spe
cifi
ed in
EN
606
01-2
-30:
199
5.
EN
106
0 :P
art 3
7.3
Eff
ect
of v
olta
ge v
aria
tion
s of
the
pow
er s
ourc
e va
riat
ions
7.3.
1In
tern
al e
lect
rica
l pow
er s
ourc
e
a) B
lood
pre
ssur
e m
easu
ring
sys
tem
s in
whi
ch th
e cu
ff p
ress
ure
is
gene
rate
d by
an
elec
tric
al p
ump
shal
l com
ply
with
56.
7 of
EN
6060
1-2-
30: 1
995;
b) C
hang
es o
f th
e vo
ltage
with
in th
e w
orki
ng r
ange
det
erm
ined
in
8.2.
1 sh
all n
otin
flue
nce
the
cuff
pre
ssur
e re
adin
g an
d th
e re
sult
of
the
bloo
d pr
essu
rem
easu
rem
ent;
c) O
utsi
de o
f th
e w
orki
ng r
ange
, no
cuff
pre
ssur
e re
adin
g an
d no
resu
lt of
the
bloo
d pr
essu
re m
easu
rem
ent s
hall
be d
ispl
ayed
.
EN
106
0 :P
art 3
7.3.
2E
xter
nal e
lect
rica
l pow
er s
ourc
e
a) B
lood
pre
ssur
e m
easu
ring
sys
tem
s in
whi
ch th
e cu
ff p
ress
ure
is
gene
rate
d by
an
elec
tric
al p
ump
shal
l com
ply
with
49.
3 an
d 49
.101
of
EN
606
01-2
-30:
199
5;
b) C
hang
es o
f th
e vo
ltage
with
in th
e w
orki
ng r
ange
spe
cifi
ed b
y th
e
man
ufac
ture
r (s
ee 9
.2)
shal
l not
infl
uenc
e th
e cu
ff p
ress
ure
read
ing
and
the
resu
lt of
the
bloo
dpr
essu
re m
easu
rem
ent.
c) I
ncor
rect
val
ues
resu
lting
fro
m v
olta
ge v
aria
tions
out
side
the
limits
give
n in
7.3
.2 b
) sh
all n
ot b
e di
spla
yed.
EN
106
0 :P
art 3
43
7.4
Pne
umat
ic s
yste
m
7.4.
1A
ir le
akag
e
Air
leak
age
shal
l not
exc
eed
a pr
essu
re d
rop
of 6
mm
Hg/
min
(0,
8 kP
a/m
in).
...
7.4.
3R
apid
exh
aust
Dur
ing
the
rapi
d ex
haus
t of
the
pneu
mat
ic s
yste
m w
ith f
ully
ope
ned
valv
e, th
e tim
e fo
r th
e pr
essu
re r
educ
tion
from
260
mm
Hg
to 1
5 m
mH
g (3
4,7
kPa
to 2
,0 k
Pa)
shal
l not
exc
eed
10 s
.
For
bloo
d pr
essu
re m
easu
ring
sys
tem
s ha
ving
the
capa
bilit
y to
m
easu
re in
a n
eona
tal/i
nfan
t mod
e , th
e tim
e fo
r th
e pr
essu
re r
educ
tion
from
150
mm
Hg
to 5
mm
Hg
(20,
0 kP
a to
0,7
kPa
) du
ring
the
rapi
d ex
haus
t of
the
pneu
mat
ic s
yste
m w
ith f
ully
ope
ned
valv
e sh
all n
ot
exce
ed 5
s.
EN
106
0 :P
art 3
Fig
ure:
Air
leak
age
test
set
-up
EN
106
0 :P
art 3
7.4.
4Z
ero
setti
ng
Blo
od p
ress
ure
mea
suri
ng s
yste
ms
shal
l be
capa
ble
of a
utom
atic
zer
o se
tting
. The
zer
o se
tting
sha
ll be
car
ried
out
at a
ppro
pria
te in
terv
als,
at
leas
t sta
rtin
g af
ter
switc
hing
on
the
devi
ce. A
t the
mom
ent o
f th
e ze
ro s
ettin
g a
gaug
e pr
essu
re o
f0
mm
Hg
(0 k
Pa)
shal
l exi
st a
nd b
e di
spla
yed
ther
eaft
er.
Dev
ices
per
form
ing
zero
set
ting
only
imm
edia
tely
aft
er s
witc
hing
on
, sha
ll sw
itch
off
auto
mat
ical
ly b
efor
e th
e dr
ifto
f th
e pr
essu
re
tran
sduc
er a
nd th
e an
alog
sign
al p
roce
ssin
g ex
ceed
s 1
mm
Hg
(0,1
kP
a).
EN
106
0 :P
art 3
Figu
re: A
pply
ing
posi
tive
or n
egat
ive
pres
sure
at t
he m
omen
t of
zero
set
ting
will
res
ult i
n a
decr
ease
or
incr
ease
of
volta
ge (
or d
ispl
ayed
pre
ssur
e), t
hus
prov
ing
that
the
zero
se
tting
sof
twar
e w
orks
cor
rect
ly.
EN
106
0 :P
art 3
44
7.5
Env
iron
men
tal p
erfo
rman
ce
7.5.
1St
orag
e
Blo
od p
ress
ure
mea
suri
ng s
yste
ms
shal
l mai
ntai
n th
e re
quir
emen
tssp
ecif
ied
in th
is
Part
of
EN
106
0 af
ter
stor
age
for
24 h
at a
tem
pera
ture
of
-5
°C a
nd f
or 2
4 h
at a
tem
pera
ture
of
+ 50
Can
d a
Rel
ativ
e H
umid
ity o
f 85
% (
non-
cond
ensi
ng).
Tes
ting
shal
l be
carr
ied
out a
t env
iron
men
tal c
ondi
tions
(se
e 7.
1.1
of E
N 1
060-
1:19
95)
in a
ccor
danc
e w
ith 8
.1 o
f E
N 1
060-
1: 1
995
afte
r th
e te
st s
ampl
e ha
s be
en
plac
edfo
r 24
h a
t a te
mpe
ratu
re o
f -
5 C
and
imm
edia
tely
aft
erw
ards
for
24
h at
a
tem
pera
ture
of
+50
°C
in a
clim
atic
cha
mbe
r.
NO
TE
: Int
egra
ted
mul
tipar
amet
erm
onito
rs m
ay c
onta
in c
ompo
nent
s w
hich
can
be
dam
aged
dur
ing
stor
age.
The
gen
eral
tem
pera
ture
ran
ge in
EN
106
0-1:
199
5 ha
s
ther
efor
e be
en r
educ
ed.
EN
106
0 :P
art 3
7.5.
2Te
mpe
ratu
re, r
elat
ive
hum
idity
7.1.
2.2
of E
N 1
060-
1: 1
995
shal
l app
ly.
The
sig
nal p
roce
ssin
g fo
r th
e de
term
inat
ion
of th
e bl
ood
pres
sure
va
lues
sha
ll no
t be
infl
uenc
ed w
ithin
the
rang
e of
tem
pera
ture
and
R
elat
ive
Hum
idity
spe
cifi
ed in
7.1
.2.2
of
EN
106
0-1:
199
5.
EN
106
0 :P
art 3
Fig
ure:
Mea
sure
men
t se
t-up
to
dete
rmin
e th
e st
abili
ty o
f th
e bl
ood
pres
sure
de
term
inat
ion;
left
: si
mul
ator
, rig
ht o
pen
clim
atic
cha
mbe
r w
ith
auto
mat
ed
sphy
gmom
anom
eter
EN
106
0 :P
art 3
7.5.
3E
lect
rom
agne
tic c
ompa
tibili
ty
Eith
er:
a)E
lect
rica
l and
/or
elec
trom
agne
tic in
terf
eren
ces
shal
l not
lead
to
degr
adat
ions
inth
e cu
ff p
ress
ure
indi
catio
n or
in th
e re
sult
of th
e bl
ood
pres
sure
mea
sure
men
t,
or;
b)if
ele
ctri
cal a
nd/o
r el
ectr
omag
netic
inte
rfer
ence
s le
ad to
an
abno
rmal
ity, t
heab
norm
ality
sha
ll be
cle
arly
indi
cate
dan
d it
shal
l be
pos
sibl
e to
res
tore
nor
mal
ope
ratio
n w
ithin
30
s af
ter
cess
atio
n of
the
elec
trom
agne
tic d
istu
rban
ce.
Tes
ting
shal
l be
carr
ied
out i
n ac
cord
ance
with
EN
606
01-1
-2: 1
993.
EN
106
0 :P
art 3
45
7.6
Sta
bilit
y of
the
cuf
f pr
essu
re in
dica
tion
The
cha
nge
of th
e cu
ff p
ress
ure
indi
catio
nsh
all n
ot b
e m
ore
than
3
mm
Hg
(0,4
kPa
) th
roug
hout
the
pres
sure
ran
ge a
fter
10
000
sim
ulat
ed m
easu
rem
ent c
ycle
s.
EN
106
0 :P
art 3
7.7
Pre
ssur
e in
dica
ting
dev
ice
7.7.
1N
omin
al r
ange
and
mea
suri
ng r
ange
The
nom
inal
ran
ge f
or th
e cu
ff p
ress
ure
mea
sure
men
t sha
ll be
spec
ifie
d by
the
man
ufac
ture
r.
The
mea
suri
ng a
nd in
dica
tion
rang
es o
f th
e cu
ff p
ress
ure
shal
l be
equa
lto
the
nom
inal
ran
ge.
Val
ues
of b
lood
pre
ssur
e m
easu
rem
ent r
esul
ts o
utsi
de th
e no
min
al
rang
eof
cuf
f pr
essu
re s
hall
be c
lear
ly in
dica
ted
as o
ut o
f ra
nge.
EN
106
0 :P
art 3
7.7.
2D
igita
l ind
icat
ion
The
num
eric
al s
tep
shal
l be
1 m
mH
g (0
,1 k
Pa).
Num
bers
sha
ll be
cle
arly
legi
ble
in a
ccor
danc
e w
ith c
laus
e 6
of E
N
6060
1-1:
199
0.
If th
e m
easu
red
valu
e of
a p
aram
eter
is to
be
indi
cate
d on
mor
e th
an
one
disp
lay,
all
the
disp
lays
sha
ll in
dica
te th
e sa
me
num
eric
al v
alue
.
Mea
sure
d, n
umer
ical
val
ues
on th
e di
spla
y(s)
, and
the
sym
bols
defi
ning
the
units
of
mea
sure
men
t sha
ll be
arr
ange
d in
suc
h a
way
so
as to
avo
id m
isin
terp
reta
tion.
EN
106
0 :P
art 3
7.9
Ove
rall
syst
em a
ccur
acy
Exc
ept
for
shor
t te
rm a
utom
atic
mod
e an
d de
vice
s in
whi
ch b
lood
pre
ssur
e is
dete
rmin
ed m
anua
lly w
ith t
he a
id o
f a
stet
hosc
ope,
the
fol
low
ing
over
all
syst
em
accu
racy
val
ues
shal
l app
ly:
a)m
axim
um m
ean
erro
r of
mea
sure
men
t: 5
mm
Hg
(0,
7 kP
a);
b)m
axim
um e
xper
imen
tal s
tand
ard
devi
atio
n: 8
mm
Hg
(1,1
kPa
).
Tes
ting
shal
l be
perf
orm
ed in
acc
orda
nce
with
EN
106
0-4.
Upo
n re
ques
t th
e m
anuf
actu
rer
shal
l pr
ovid
e ev
iden
ce t
o th
e N
otif
ied
Bod
y th
at
thes
e re
quir
emen
ts a
re m
et.
(EN
106
0-3:
1997
/A1:
2005
)
EN
106
0 :P
art 3
46
7.11
Saf
ety
7.11
.1C
uff p
ress
ure
It s
hall
be p
ossi
ble
to a
bort
any
blo
od p
ress
ure
mea
sure
men
t at a
ny ti
me
by s
ingl
e ke
y op
erat
ion
and
this
sha
ll le
ad to
a r
apid
exh
aust
(se
e 7.
4.3)
.
7.11
.2U
naut
hori
zed
acce
ss
All
cont
rols
that
aff
ect a
ccur
acy
shal
l be
seal
ed a
gain
st u
naut
hori
zed
acce
ss.
7.11
.3Tu
bing
con
nect
ors
Lue
rlo
ck c
onne
ctor
s sh
all n
ot b
e us
ed.
NO
TE
: In
orde
r to
avo
id p
ossi
ble
mis
conn
ectio
n w
ith in
trav
ascu
lar
syst
ems
Lue
rsl
ip c
onne
ctor
s sh
ould
not
be
used
.
EN
106
0 :P
art 3
EN
106
0 N
on-i
nvas
ive
sphy
gmom
anom
eter
s
•E
N 1
060-
1 G
ener
al r
equi
rem
ents
(19
95)
•E
N 1
060-
2 Su
pple
men
tary
req
uire
men
ts f
or m
echa
nica
l
sphy
gmom
anom
eter
s (1
995)
•E
N 1
060-
3 Su
pple
men
tary
req
uire
men
ts f
or e
lect
ro-m
echa
nica
l
bloo
d pr
essu
re m
easu
ring
sys
tem
s (
1997
/ 20
05)
•E
N 1
060-
4 T
est p
roce
dure
s to
det
erm
ine
the
over
all s
yste
m
accu
racy
of
auto
mat
ed n
on-i
nvas
ive
sphy
gmom
anom
eter
s
(200
4)
EN
106
0 :P
art 4
1 S
cope
Thi
s do
cum
ent d
escr
ibes
test
pro
cedu
res
for
inve
stig
atio
ns to
dete
rmin
e th
e ov
eral
l sys
tem
acc
urac
y of
aut
omat
ed n
on-i
nvas
ive
sphy
gmom
anom
eter
s, d
esig
ned
for
the
indi
rect
mea
sure
men
t of
bloo
d pr
essu
re.
EN
106
0 :P
art 4
4.1
Gen
eral
info
rmat
ion
on t
he n
on-i
nvas
ive
refe
renc
e m
etho
ds
... The
aus
culta
tory
bloo
d pr
essu
re m
easu
rem
ents
des
crib
ed s
hall
be c
arri
ed o
ut b
y
two
obse
rver
s by
mea
ns o
f a
doub
le s
teth
osco
pe. T
he a
uscu
ltato
ryre
fere
nce
valu
e
will
then
be
the
mea
n va
lue
of th
e tw
o va
lues
det
erm
ined
by
the
obse
rver
s. T
he
diff
eren
ce b
etw
een
both
val
ues
shal
l not
exc
eed
4 m
mH
g . A
ny m
easu
rem
ents
with
obse
rver
-to-
obse
rver
dif
fere
nces
gre
ater
than
4 m
mH
g sh
all n
ot b
e in
clud
ed in
the
data
set
. The
num
ber
of d
isca
rded
mea
sure
men
ts s
hall
not b
e gr
eate
r th
an th
e
num
ber
of th
e re
quir
ed v
alid
mea
sure
men
ts.
... The
cal
ibra
ted
refe
renc
e m
anom
eter
ssh
all c
ompl
y w
ith th
e re
quir
emen
ts o
f
EN
106
0-1
to E
N 1
060-
3 bu
t sha
ll no
t exc
eed
erro
r lim
its o
f 1
mm
Hg
(0,1
kPa
)
with
dro
ppin
g cu
ff p
ress
ure
prio
r to
the
star
t of
the
clin
ical
inve
stig
atio
n.
EN
106
0 :P
art 4
47
EN
106
0 :P
art 4
4.6
Subj
ects
4.6.
1 G
ener
alT
he s
elec
tion
of th
e su
bjec
ts a
nd th
eir
num
ber
depe
nds
on th
e in
tend
ed p
urpo
se(.
..) o
f th
e de
vice
to b
e te
sted
.L
imits
of
appl
icat
ion
stat
ed in
the
user
s m
anua
l sha
ll be
take
n in
to a
ccou
nt, e
.g.
conc
erni
ng a
rrhy
thm
ia (
see
also
4.8
).If
no
spec
ial p
urpo
se is
inte
nded
, e.g
. mea
sure
men
t dur
ing
preg
nanc
y, th
efo
llow
ing
appl
ies
only
for
adu
lts a
nd c
hild
ren:
-at
leas
t 40
% s
hall
be m
ale
and
at le
ast 4
0 %
sha
ll be
fem
ale;
-be
twee
n 50
% a
nd 7
5 %
sha
ll be
old
er th
an 5
0 ye
ars;
-be
twee
n 50
% a
nd 7
5 %
sha
ll ha
ve a
cir
cum
fere
nce
of th
e ar
m, w
hich
lies
with
in
the
uppe
r ha
lf o
f th
e sp
ecif
ied
rang
e of
use
of
the
cuff
(if
app
licab
le);
-be
twee
n 50
% a
nd 7
5 %
sha
ll ha
ve a
cir
cum
fere
nce
of th
e w
rist
, whi
ch li
es
with
in th
e up
per
half
of
the
spec
ifie
d ra
nge
of u
se o
f th
e cu
ff (
if a
pplic
able
);-
at le
ast 1
0 %
bel
ow 1
10 m
mH
g sy
stol
ic b
lood
pre
ssur
e;-
at le
ast 1
0 %
abo
ve 1
60 m
m H
g sy
stol
ic b
lood
pre
ssur
e;-
at le
ast 1
0 %
bel
ow 7
0 m
mH
g di
asto
lic b
lood
pre
ssur
e;-
at le
ast 1
0 %
abo
ve 1
00 m
m H
g di
asto
lic b
lood
pre
ssur
e.
EN
106
0 :P
art 4
4.6.
2 N
on-i
nvas
ive
refe
renc
e m
easu
rem
ent
4.6.
2.1
Gen
eral
A m
inim
um o
f 3
mea
sure
men
tssh
all b
e ca
rrie
d ou
t on
each
of
at le
ast 8
5 su
bjec
ts.
4.6.
2.2
Add
ition
al r
equi
rem
ents
for
sphy
gmom
anom
eter
s m
easu
ring
und
er p
hysi
cal
load
At l
east
6 p
aire
d m
easu
rem
ents
shal
l be
carr
ied
out o
n ea
ch o
f at
leas
t 85
subj
ects
. A
s m
uch
as p
ossi
ble,
fem
ale
and
mal
e su
bjec
ts s
hall
be e
venl
y di
stri
bute
d w
hile
at
mos
t25
% s
hall
orig
inat
e fr
om th
e fi
eld
of s
port
s m
edic
ine.
The
dif
fere
nt b
lood
pre
ssur
e gr
oups
(se
e 4.
6.1)
sha
ll be
cla
ssif
ied
in a
ccor
danc
e w
ith th
e fi
rst v
alid
blo
od p
ress
ure
refe
renc
e m
easu
rem
ents
at r
est.
4.6.
2.3
Add
ition
al r
equi
rem
ents
for
ambu
lato
ry s
phyg
mom
anom
eter
sA
t lea
st 6
pai
red
mea
sure
men
tssh
all b
e ca
rrie
d ou
t on
each
of
at le
ast 8
5 su
bjec
ts.
The
dif
fere
nt b
lood
pre
ssur
e gr
oups
(se
e 4.
6.1)
sha
ll be
cla
ssif
ied
in a
ccor
danc
e w
ith th
e fi
rst v
alid
blo
od p
ress
ure
refe
renc
e m
easu
rem
ents
at r
est.
EN
106
0 :P
art 4
N 1
EN
106
0 :P
art 4
48
N 2
EN
106
0 :P
art 4
N 2
EN
106
0 :P
art 4
Fig.
: Clin
ical
test
set
-up
acco
rdin
g N
3 f
or d
evic
es w
ith d
efla
tion
rate
s hi
gher
than
3 m
mH
g/s
(seq
uent
ial m
easu
rem
ent)
.
t 1t 2
EN
106
0 :P
art 4
subj
ect n
subj
ect n
+1
N 3
EN
106
0 :P
art 4
49
Tha
nk y
oufo
r yo
ur a
ttent
ion!
50
Eur
opea
n si
mul
ator
to
tes
t au
tom
ated
sph
ygm
oman
omet
er
Step
han
Mie
kePh
ysik
alis
ch-T
echn
isch
e B
unde
sans
talt
Ber
lin
Ack
now
ledg
emen
ts:
The
dev
elop
men
t was
fun
ded
by a
gra
nt f
rom
the
Eur
opea
n C
omm
unity
und
er th
e ”C
ompe
titiv
e an
d Su
stai
nabl
e G
row
th”
prog
ram
me,
gr
ant G
6RD
-CT
C-2
002-
0070
6.
Part
of
the
pres
enta
tion
is ta
ken
from
a p
rese
ntat
ion
“The
fut
ure
for
sim
ulat
ors-
Tow
ards
a b
ette
r va
lidat
ion
of b
lood
pre
ssur
e m
easu
ring
dev
ices
”he
ld a
t the
ESH
m
eetin
g in
Mad
rid,
Jun
e 20
06 b
y Jo
hn A
moo
re, A
lan
Mur
ray,
Ste
phan
Mie
ke
Stru
ctur
e
•A
ccur
acy
requ
irem
ents
•W
hysi
mul
ator
s?
•D
esig
n of
sim
ulat
ors
•R
esul
tsfr
omm
easu
rem
ents
with
sim
ulat
ors
•O
utlo
ok
Acc
urac
yre
quir
emen
ts
EN
106
0, p
art3
, cla
use
7.9
Ove
rall
syst
emac
cura
cy:
... th
efo
llow
ing
over
alls
yste
mac
cura
cysh
alla
pply
:
a) m
ax. m
ean
erro
rof
mea
sure
men
t:±
5 m
mH
g
b) m
ax. e
xper
imen
tal s
tand
ard
devi
atio
n:8
mm
Hg
Acc
urac
yre
quir
emen
ts
Tes
t met
hods
(cl
inic
al tr
ials
):
•E
N 1
060-
4
•B
HS
Prot
ocol
•A
NSI
/AA
MI
SP 1
0
•E
SH P
roto
col
51
Stru
ctur
e
•A
ccur
acy
requ
irem
ents
•W
hysi
mul
ator
s?
•D
esig
n of
sim
ulat
ors
•R
esul
tsfr
omm
easu
rem
ents
with
sim
ulat
ors
•O
utlo
ok
Wha
t de
term
ines
acc
urac
y?
Pre
ssur
eT
rans
duce
r
Con
vent
iona
lst
atic
calib
rati
on.
To
with
in
3 m
mH
g
Alg
orit
hm
Set o
f em
piri
cal
rule
s de
term
ine
bloo
d pr
essu
re
How
is t
his
veri
fied
?
Stat
istic
alco
mpa
riso
n in
85
subj
ects
Osc
illom
etri
cpr
essu
repu
lses
onC
uff
Pre
ssur
e
Why
sim
ulat
ors
?
Fig.
:Clin
ical
test
set
-up
acco
rdin
g E
N 1
060-
4 fo
r de
vice
s w
ith d
efla
tion
rate
s hi
gher
than
3 m
mH
g/s
(seq
uent
ial m
easu
rem
ent)
.
t 1t 2
Fig.
: Clin
ical
test
set
-up
acco
rdin
g E
N 1
060-
4 fo
r de
vice
s w
ith d
efla
tion
rate
s hi
gher
than
3 m
mH
g/s
(seq
uent
ial m
easu
rem
ent)
.
t 1t 2
52
Why
sim
ulat
ors
?
Clin
ical
test
:
•C
linic
al te
sts
are
limite
d to
85
subj
ects
due
to ti
me
and
cost
s.
•L
ack
of in
clus
ion
of d
iffe
rent
pop
ulat
ion
grou
ps
(Dev
ice
inac
cura
cy in
cer
tain
pop
ulat
ion
grou
ps).
•C
linic
al te
sts
are
hard
ly d
eter
min
ing
the
limits
of
appl
icat
ion.
•T
he r
esul
ts o
f cl
inic
al te
sts
are
a m
ixtu
re o
f de
vice
rel
ated
as
wel
l as
proc
edur
e re
late
d er
rors
(e.g
. dig
ital p
refe
renc
es, t
oo
high
def
latio
n ra
tes)
; it i
s ha
rdly
pos
sibl
e to
dif
fer
betw
een
both
.
•V
aria
bilit
y of
fin
ding
s in
dif
fere
nt c
linic
al s
tudi
es.
•R
epea
tabi
lity
test
s ca
nnot
be
perf
orm
ed w
ith c
linic
al te
sts.
Stru
ctur
e
•A
ccur
acy
requ
irem
ents
•W
hysi
mul
ator
s?
•D
esig
n of
sim
ulat
ors
•R
esul
tsfr
omm
easu
rem
ents
with
sim
ulat
ors
•O
utlo
ok
Des
ign
of s
imul
ator
s
The
rear
etw
odi
ffer
ent a
ppro
ache
sto
the
desi
gnof
sim
ulat
ors:
•th
ear
tific
allim
b
Des
ign
of s
imul
ator
s
Fig.
: the
art
ific
ial l
imb
53
Fig:
Inv
asiv
e bl
ood
pres
sure
over
tim
e
Des
ign
of s
imul
ator
s
The
rear
etw
odi
ffer
ent
appr
oach
esto
the
desi
gnof
sim
ulat
ors:
•th
ear
tific
allim
b
•th
esi
gnal
gene
rato
r
Des
ign
of s
imul
ator
s
Fig.
: the
sig
nal g
ener
ator
Upp
er p
art:
Cuf
f pr
essu
re d
ecay
ove
r tim
e
Low
er p
art:
Aco
ustic
sig
nal (
Kor
otko
ffso
und)
over
tim
e;th
e be
gin
and
end
of th
e K
orot
koff
soun
d ar
e m
arke
r fo
r th
e sy
stol
ic (
SYS)
and
dias
tolic
(D
IA)
bloo
d pr
essu
re
54
Fig.
:upp
er p
art:
curv
e of
def
latin
g cu
ff p
ress
ure,
lo
wer
par
t: am
plitu
de o
f pr
essu
re o
scill
atio
ns
The
osc
illom
etri
cm
etho
d w
as d
evel
oped
bas
ed o
n em
piri
cal d
ata.
On
the
basi
s of
ext
ensi
ve in
vest
igat
ions
, the
fol
low
ing
rela
tions
hav
e be
en d
isco
vere
d:
1.T
he m
axim
um o
f th
e os
cilla
tion
ampl
itude
Am
axco
inci
des
with
the
mea
n ar
teri
al b
lood
pres
sure
, in
shor
t MA
P.
2.T
he s
ysto
lic b
lood
pre
ssur
e is
det
erm
ined
at a
bout
0.5
Am
ax.
3.T
he d
iast
olic
blo
od p
ress
ure
is d
eter
min
ed a
t abo
ut 0
.8A
max
.
Not
e1:
Onl
y th
e pr
inci
ple
unde
rlyi
ng th
e pr
oced
ure
mos
t fre
quen
tly a
pplie
d h
as b
een
desc
ribe
d
here
; to
impr
ove
its r
elia
bilit
y, th
e m
etho
d ha
s be
en r
efin
ed a
nd e
xten
ded
in m
any
aspe
cts.
Not
e2:
The
fac
tors
giv
en a
bove
are
thos
e ro
ughl
y va
lid f
or m
easu
rem
ents
at th
e up
per
arm
. The
fact
ors
for
the
wri
star
e to
tally
dif
fere
nt.
Osc
illom
etri
cm
etho
d
sys
dia
Fig.
:Osc
illom
etri
cpr
inci
ple
sys
dia
Fig.
:Osc
illom
etri
cpr
inci
ple
55
Des
ign
of s
imul
ator
s
Fig.
: the
sig
nal g
ener
ator
Fig.
:top
: os
cilla
tions
gen
erat
ed b
y th
e C
uffL
ink;
righ
t: os
cilla
tions
take
n fr
om
a hu
man
upp
er a
rm
Art
ific
ial w
avef
orm
Mos
t co
mm
erci
al s
imul
ator
s
Cuf
fLin
k S
imul
ator
: O
scill
omet
ric w
avef
orm
sha
pes
0
0.51
1.52
050
100
150
200
250
Cuf
f pr
essu
re (
mm
Hg)
Pulse Amplitude (mmHg)
60/3
0
80/5
0
100/
65
120/
80
150/
100
200/
150
•W
avef
orm
sm
ooth
and
sha
pe u
ncha
nged
wit
h pr
essu
re
•P
ulse
sha
pe d
oesn
’t c
hang
e be
twee
n sy
stol
e an
d di
asto
le
Mea
sure
men
ts p
erfo
rmed
with
the
Cuf
fLin
k
56
Mea
sure
men
ts p
erfo
rmed
with
the
Cuf
fLin
kC
onse
quen
ce
Con
vent
iona
l sim
ulat
ors
like
Cuf
flin
k, S
mar
tarm
,
BP-
Pum
p ar
e
•un
able
to te
st a
ccur
acy
but
•ab
le to
test
rep
eatib
ility
and
repr
oduc
ebili
ty
Con
cept
of
the
EU
sim
ulat
or:
•co
llect
ion
of o
scill
atio
ns f
rom
hum
an s
ubje
cts
(with
a s
epar
ate
devi
ce, i
.e. r
ecor
ding
uni
t)
•da
taba
se o
f hu
man
osc
illog
ram
s
•si
mul
atio
n of
rec
orde
d os
cilla
tion
•ad
ditio
nal s
imul
atio
n of
art
efac
ts
Con
sequ
ence
Dat
a co
llect
ion
with
rec
ordi
ng u
nit
Fig.
:Blo
od p
ress
ure
mea
sure
men
t tak
en b
y tw
o in
depe
nden
t ob
serv
ers
usin
g a
dual
-hea
ded
stet
hosc
ope
57
Fig.
: Dat
ase
gmen
tatio
n
Soft
war
e to
pro
cess
the
sign
als
for
sim
ulat
ion
Soft
war
e to
pro
cess
the
sign
als
for
sim
ulat
ion
Soft
war
e to
pro
cess
the
sign
als
for
sim
ulat
ion
EU
sim
ulat
or:
Prin
cipl
e
58
EU
sim
ulat
or:
Pres
sure
Pul
se G
ener
ator
diap
hrag
mle
ver
tape
mot
or
EU
sim
ulat
or:
Pres
sure
Pul
se G
ener
ator
EU
sim
ulat
or:
Pres
sure
Pul
se G
ener
ator
leve
rta
pem
otor
Phy
siol
ogic
al W
avef
orm
A f
ew s
peci
alis
ed s
imul
ator
s
•O
scill
omet
ric
wav
efor
m v
arie
s be
twee
n in
divi
dual
s
•Pu
lse
shap
e va
ries
bet
wee
n sy
stol
e an
d di
asto
le
012
70
10
01
30
16
01
90
Cu
ff P
res
su
re (
mm
Hg
)
Pulse Amplitude (mmHg)
01234
30
60
90
12
0
Cu
ff P
res
su
re (
mm
Hg
)
Pulse Amplitude (mmHg)
Pul
se
at s
ysto
lic
cuff
pre
ssur
e
0%20%
40%
0.0
0.2
0.4
0.6
0.8
Tim
e (s
ec) Dia
stol
iccu
ff p
ress
ure
0%20%
40%
60%
80%
0.0
0.2
0.4
0.6
0.8
Tim
e (s
ec)
59
Stru
ctur
e
•A
ccur
acy
requ
irem
ents
•W
hysi
mul
ator
s?
•D
esig
n of
sim
ulat
ors
•R
esul
tsfr
omm
easu
rem
ents
wit
hsi
mul
ator
s•
Out
look
Phy
siol
ogic
al S
imul
ator
eva
luat
ion
Am
oore
et a
l, B
lood
Pre
ssur
e M
onito
ring
, 200
6, 1
1: 6
3-67
Om
ron
907
-40
-30
-20
-1001020
2040
6080
100
120
140
160
180
200
220
Aus
cult
ator
y re
fere
nce
(mm
Hg)
NIBP - auscultation (mmHg)
Dia
stol
icS
ysto
lic
Typ
es o
f os
cillo
met
ric
wav
efor
ms
Aff
ect:
Sys
tem
atic
err
or,
Con
sist
ency
Om
ron
907
-1001020304050
NIBP - auscultatory (mmHg)
Syst
olic
Dia
stol
ic
Mur
ray
I et
al,
in p
repa
ratio
n
Stru
ctur
e
•A
ccur
acy
requ
irem
ents
•W
hysi
mul
ator
s?
•D
esig
n of
sim
ulat
ors
•R
esul
tsfr
omm
easu
rem
ents
with
sim
ulat
ors
•O
utlo
ok
60
Pro
mis
e of
sim
ulat
or v
alid
atio
n:C
onsi
sten
t, re
liabl
e, c
ompr
ehen
sive
val
idat
ion
of B
P de
vice
s
Sim
ulat
or r
equi
rem
ents
•T
echn
ical
: Acc
urat
e re
gene
ratio
n of
osc
illom
etri
c pu
lses
•W
avef
orm
set
s:C
ompr
ehen
sive
dat
abas
e of
osc
illom
etri
c
wav
efor
ms
–se
ts o
f pu
lses
and
ass
ocia
ted
cuff
pre
ssur
es
•Sp
ecia
lised
con
ditio
ns:
Spec
ialis
ed p
atie
nt c
ondi
tions
•Fo
r de
velo
pers
:Se
ts o
f w
avef
orm
s av
aila
ble
for
deve
lope
rs
•Fo
r va
lidat
ion
cent
res:
Sepa
rate
set
s fo
r de
vice
val
idat
ion?
Can
sim
ulat
or e
valu
atio
n re
plac
e cl
inic
al s
tudy
val
idat
ion?
Yes
:In
itial
wor
ks s
ugge
sts
that
it c
an, p
rovi
ded
a.Su
ffic
ient
wav
efor
ms
b.W
avef
orm
s of
spe
cial
ised
con
ditio
ns
c.Pr
otoc
ol d
evel
oped
and
app
rove
d
Impr
ove:
Can
sim
ulat
or e
valu
atio
n of
fer
bene
fits
?
a.B
ette
r un
ders
tand
ing
of o
scill
omet
ric
tech
niqu
e
b.Sp
ecia
lised
con
ditio
ns
c.M
ore
than
sim
ply
repl
icat
e cl
inic
al p
roto
col
Tow
ards
the
idea
l sim
ulat
or
Req
uire
s
•C
ompr
ehen
sive
dat
abas
e of
wav
efor
ms
•V
alid
atio
n pr
otoc
ol th
at a
sses
ses
accu
racy
ove
r co
mpr
ehen
sive
ran
ge o
f co
nditi
ons
•In
depe
nden
t ver
ific
atio
n of
the
sim
ulat
or
Pro
mis
es
•B
ette
r un
ders
tand
ing
of o
scill
omet
ric
wav
efor
m
61
AP
EC
/AP
LM
F T
rain
ing
Cou
rses
in L
egal
Met
rolo
gy
(CT
I-11
/200
6T)
Sem
inar
on
Aut
omat
ed S
phyg
mom
anom
eter
s
Cur
rent
sit
uati
on in
Ger
man
y fo
r Sp
hygm
oman
omet
ers
Step
han
Mie
kePh
ysik
alis
ch-T
echn
isch
e B
unde
sans
talt
Ber
lin
* A
ustr
ia (
1995
)*
Bel
gium
(19
52/5
8)*
Cyp
rus
(200
4)*
Cze
ch R
epub
lic (
2004
)*
Den
mar
k (1
973)
* E
ston
ia (
2004
)*
Finl
and
(199
5)*
Fran
ce (
1952
/58)
* G
erm
any
(195
2/58
)*
Gre
ece
(198
1)*
Hun
gary
(20
04)
* Ir
elan
d (1
973)
* It
aly
(195
2/58
)*
Lat
via
(200
4)*
Lith
uani
a (2
004)
* L
uxem
bour
g (1
952/
58)
* M
alta
(20
04)
* T
he N
ethe
rlan
ds
(195
2/58
)*
Pola
nd (
2004
)*
Port
ugal
(19
86)
* Sl
ovak
ia (
2004
)*
Slov
enia
(20
04)
* Sp
ain
(198
6)*
Swed
en (
1995
)*
Uni
ted
Kin
gdom
(19
73)
Eur
opea
n D
irec
tive
s
The
cou
ncil
of th
e E
urop
ean
Com
mun
ity p
repa
red
thre
e di
rect
ives
on m
edic
al d
evic
es:
•C
ounc
il D
irec
tive
90/3
85/E
EC
of
20 J
une
1990
con
cern
ing
activ
e im
plan
tabl
e m
edic
al d
evic
es(A
IMD
)
•C
ounc
il D
irec
tive
93/4
2/E
EC
of
14 J
une
1993
con
cern
ing
med
ical
dev
ices
(MD
D)
•E
urop
ean
Parl
iam
ent a
nd C
ounc
il D
irec
tive
98/7
9/E
C o
f
27 O
ctob
er 1
998
on in
vitr
o di
agno
stic
med
ical
dev
ices
(IV
D)
The
se d
irec
tives
hav
e be
en im
plem
ente
d in
to th
e na
tiona
l leg
isla
tion
of e
ach
EU
mem
ber
stat
e.E
lect
ric
or e
lect
roni
c m
edic
al d
evic
es b
eari
ng th
e C
E-m
ark
mus
t als
o ta
ke in
to a
ccou
nt
othe
r E
C d
irec
tives
, whe
n ap
prop
riat
e, e
.g. t
he C
ounc
il D
irec
tive
89/3
36/E
EC
of
3 M
ay
1989
on
the
appr
oxim
atio
n of
the
law
s of
the
Mem
ber
Stat
es r
elat
ing
to e
lect
rom
agne
tic
com
patib
ility
.
Med
ical
Dev
ice
Dir
ectiv
eM
edic
al D
evic
e D
irec
tive
Dec
lara
tion
of c
onfo
rmity
with
the
allo
ws
to e
nter
the
Eur
opea
n m
arke
t
for
med
ical
dev
ices
with
a m
easu
ring
fun
ctio
n: +
ID
-num
ber
of N
otif
ied
Bod
y!
62
Bas
ic s
teps
to c
ompl
ianc
eB
asic
ste
ps to
com
plia
nce
Det
erm
ine
whe
ther
the
prod
uct i
s a
med
ical
dev
ice
and
com
plie
s w
ith th
e M
DD
Det
erm
ine
whe
ther
the
prod
uct i
s a
med
ical
dev
ice
and
com
plie
s w
ith th
e M
DD
inte
nded
pur
pose
/ us
e
Det
erm
ine
whe
ther
the
prod
uct i
s a
med
ical
dev
ice
and
com
plie
s w
ith th
e M
DD
Det
erm
ine
whe
ther
the
prod
uct i
s a
med
ical
dev
ice
and
com
plie
s w
ith th
e M
DD
Art
icle
1D
efin
itio
ns, s
cope
(g)
'inte
nded
pur
pose
' mea
ns th
e us
e fo
r w
hich
the
devi
ce is
inte
nded
acc
ordi
ng to
the
data
sup
plie
d by
th
e m
anuf
actu
rer
on th
e la
belli
ng, i
n th
e in
stru
ctio
nsan
d/or
in p
rom
otio
nal m
ater
ials
;
Cla
ssif
icat
ion
of th
e m
edic
al d
evic
eC
lass
ific
atio
n of
the
med
ical
dev
ice
18ru
les
for:
1.no
n-in
vasi
vede
vice
s2.
inva
sive
dev
ices
3.ac
tive
devi
ces
4....
.
dete
rmin
eto
whi
chcl
ass
a m
edic
alde
vice
belo
ngs:
Cla
ssI
Cla
ssI
Cla
ssII
I C
lass
III
Cla
ssII
bC
lass
IIb
Cla
ssII
aC
lass
IIa
63
Cla
ssif
icat
ion
of th
e m
edic
al d
evic
eC
lass
ific
atio
n of
the
med
ical
dev
ice
exam
ple:
auto
mat
edsp
hygm
oman
omet
er
conf
orm
ity a
sses
smen
t rou
tes
conf
orm
ity a
sses
smen
t rou
tes
Cla
ss I
with
m
easu
ring
fun
ctio
n
tech
nica
l file
Ann
ex V
IIch
ecke
d by
notif
ied
body
Cla
ss I
Ia
tech
nica
l file
and
dec
lara
tion
of c
onfo
rmity
Ann
ex V
IIch
ecke
d by
not
ifie
d bo
dy
prod
uct
veri
fica
tion
Ann
ex I
Vch
ecke
d by
n.b
.
Q-a
ssur
ance
prod
uctio
nA
nnex
Vch
ecke
d by
n.b
.
Q-a
ssur
ance
prod
uct
Ann
ex V
Ich
ecke
d by
n.b
.
xxxx
(no.
of
notif
ied
body
)
exam
ple:
non-
auto
mat
edsp
hygm
oman
omet
er
exam
ple:
auto
mat
edsp
hygm
oman
omet
er
Com
plia
nce
to th
eE
ssen
tial R
equi
rem
ents
Com
plia
nce
to th
eE
ssen
tial R
equi
rem
ents
Ann
ex I
Ann
ex I
64
10.D
evic
es w
ith
a m
easu
ring
fun
ctio
n
10.1
. Dev
ices
with
a m
easu
ring
fun
ctio
n m
ust b
e de
sign
ed
and
man
ufac
ture
d in
suc
h a
way
as
to p
rovi
de s
uffi
cien
tac
cura
cy a
nd s
tabi
lity
with
in a
ppro
pria
te li
mits
of
accu
racy
an
d ta
king
acc
ount
of
the
inte
nded
pur
pose
of
the
devi
ce.
The
lim
its o
f ac
cura
cy m
ust b
e in
dica
ted
by th
e m
anuf
actu
rer.
10.2
. The
mea
sure
men
t, m
onito
ring
and
dis
play
sca
le m
ust
be d
esig
ned
in li
ne w
ith e
rgon
omic
pri
ncip
les,
taki
ng
acco
unt o
f th
e in
tend
ed p
urpo
se o
f th
e de
vice
.
10.3
. The
mea
sure
men
ts m
ade
by d
evic
es w
ith a
mea
suri
ng
func
tion
mus
t be
expr
esse
d in
lega
l uni
tsco
nfor
min
g to
the
prov
isio
ns o
f C
ounc
il D
irec
tive
80/1
81/E
EC
()
Har
mon
ized
Stan
dard
s
Ann
ex I
CE
N/
CE
NE
LE
C
Not
man
dato
rybu
tcom
plia
nce
assu
med
, e.g
. EN
106
0
Mor
epa
perw
ork
Ann
ex I
Tec
hnic
alF
ileV
igila
nce
Syst
em
Ris
kA
naly
sis
65
Aft
er s
ale:
nat
iona
l reg
ulat
ions
are
pos
sibl
eA
fter
sal
e: n
atio
nal r
egul
atio
ns a
re p
ossi
ble
Ger
man
y:O
rdin
ance
on
the
inst
alla
tion,
ope
ratio
n an
d us
e of
m
edic
al d
evic
es:
It r
egul
ates
the
inst
alla
tion,
ope
ratio
n an
d us
e of
med
ical
de
vice
saf
ter
sale
and
is a
ddre
ssed
to th
e us
er, n
ot to
the
man
ufac
ture
r.
Met
rolo
gica
l Che
cke.
g. s
phyg
mom
anom
eter
eve
ry 2
y
Met
rolo
gica
l che
ck f
or s
phyg
mom
anom
eter
Met
rolo
gica
l che
ck f
or s
phyg
mom
anom
eter
Wha
t is
chec
ked?
•cu
ff p
ress
ure
accu
racy
•ai
r le
akag
e•
for
Hg
devi
ces:
sto
ppin
g de
vice
s at
tube
and
res
ervo
ir•
aner
oid
devi
ces:
hys
tere
sis
•fu
nctio
nal t
est
Who
is c
heck
ing?
Any
body
, who
has
the
know
-how
, the
equ
ipm
ent a
ndis
in
depe
nden
t fro
m c
omm
erci
al in
tere
sts,
e.g
. rep
air.
Met
rolo
gica
l che
ck f
or s
phyg
mom
anom
eter
Met
rolo
gica
l che
ck f
or s
phyg
mom
anom
eter
Whi
ch e
quip
men
t is
requ
ired
?•
calib
rate
d re
fere
nce
man
omet
er w
ith a
n er
ror
less
than
0,8
mm
Hg
(0,1
kPa)
,•
stop
wat
ch w
ith a
n er
ror
less
than
0,1
s,•
ball
(han
d) p
ump
with
a d
efla
tion
valv
e,•
rigi
d m
etal
ves
sel w
ith a
cap
acity
of
500
ml ±
5%
(upp
er a
rm d
evic
e) o
r 10
0m
l ±5
% (
neon
atal
or
wri
st d
evic
e),
•ri
gid
cylin
der
for
cuff
, T-p
iece
con
nect
ors
and
hose
s,•
for
Hg
man
omet
er: c
olle
ctin
g ve
ssel
of
adeq
uate
siz
e,•
optio
nal:
sim
ulat
or f
or a
utom
ated
sph
ygm
oman
omet
er
66
Kil
og
ram
1875
the
Met
ricC
onve
ntio
n w
as c
oncl
uded
1885
Japa
n jo
ined
the
Met
ricC
onve
ntio
n
1890
The
pro
toty
pes
of M
eter
and
Kilo
gram
wer
e ar
rived
at J
apan
1891
1stJa
pane
se M
easu
rem
ent l
aw w
as p
rom
ulga
ted
(enf
orce
din
189
3)
1903
Firs
t Nat
iona
l Res
earc
h La
bora
tory
of M
etro
logy
was
est
ablis
hed
1951
2nd
Japa
nese
Mea
sure
men
t law
was
pro
mul
gate
d (e
nfor
ced
in 1
952)
1955
In
tern
atio
nal O
rgan
izat
ion
of L
egal
Met
rolo
gyO
IML
was
est
ablis
hed
1959
Law
am
ende
d
1961
Ja
pan
join
ed O
IML
Nat
iona
lRes
earc
hL
abor
ator
y of
Met
rolo
gy w
as e
stab
lishe
d
1966
La
wam
ende
d
Mete
r19
80T
yp
e a
pp
roval syste
m f
or
Sp
hyg
mo
man
om
ete
rssta
rted
(Ord
inan
ce o
f the
Min
istr
y of
Eco
nom
y, T
rade
and
Indu
stry
(M
ET
I) w
as
amen
ded)
1992
Pre
sent
Jap
anes
e M
easu
rem
ent l
aw w
as p
rom
ulga
ted
(enf
orce
din
199
3)
1994
AP
LMF
was
esta
blis
hed
1999
Law
amen
ded
2001
OIM
L R
16 E
ditio
n 20
02 w
as a
ppro
ved
for
final
pub
licat
ion
byth
e In
tern
atio
nalC
omm
ittee
of L
egal
Met
rolo
gy(w
as s
ubm
itted
to th
e In
tern
atio
nal C
onfe
renc
e of
Leg
al M
etro
logy
in 2
004
for
form
al s
anct
ion)
Nat
iona
l Ins
titut
e of
Adv
ance
dIn
dust
rial S
cien
ce a
nd T
echn
olog
y (A
IST
)w
as e
stab
lishe
d (r
emod
eled
) fr
om
2005
JIS
T11
15 w
as a
men
ded
as N
on-in
vasi
ve A
utom
ated
Sph
ygm
oman
omet
ers
base
d on
OIM
L R
16-2
.
Ord
inan
ce o
f the
Min
istr
y of
Eco
nom
y, T
rade
and
Indu
stry
ME
TI)
was
am
ende
dM
ITI
in
Nat
iona
l Res
earc
h La
bora
tory
of M
etro
logy
un
der
the
form
er A
genc
y of
Indu
stria
l Sci
ence
and
Tec
hnol
ogy
67
Con
trib
ute
to e
cono
mic
dev
elop
men
t and
cul
tura
l enh
ance
men
t
Impl
emen
tatio
n of
app
ropr
iate
m
easu
rem
ent
Pro
mot
ion
of a
uton
omou
s m
easu
rem
ent a
dmin
istr
atio
n
Est
ablis
h st
anda
rds
for
mea
sure
men
tE
nsur
e ap
prop
riate
impl
emen
tatio
n of
m
easu
rem
ent
Uni
form
ity o
f uni
tsP
rovi
sion
of m
easu
rem
ent
stan
dard
sP
rovi
sion
of a
ccur
ate
mea
surin
g in
stru
men
ts
Acc
urat
e an
d fa
ir ex
ecut
ion
of
the
law
Sys
tem
of s
peci
al b
ottle
s
Res
tric
tion
for
tran
sfer
of s
peci
al s
peci
fied
mea
surin
g in
stru
men
t
Not
ifica
tion
of b
usin
ess
rela
ting
to m
easu
ring
inst
rum
ents
Uni
form
ity o
f uni
ts
Pro
visi
on o
f m
easu
rem
ent
stan
dard
s
Pro
visi
on o
f ac
cura
te m
easu
ring
inst
rum
ents
Insp
ectio
n of
ver
ifica
tion
stan
dard
s
Sys
tem
of d
esig
nate
d m
anuf
actu
rers
Ver
ifica
tions
Con
form
ity o
f mea
sure
men
t uni
ts w
ith In
tern
atio
nal
Sys
tem
of U
nits
(S
Iun
its)
Pro
hibi
tion
of u
se w
ithno
n-le
gal m
easu
rem
ent u
nits
Cal
ibra
tion
of m
easu
ring
inst
rum
ents
, sys
tem
of
Acc
redi
ted
Cal
ibra
tion
Labo
rato
ries
(JC
SS
)N
ITE
Res
tric
tion
on U
se
Per
iodi
c in
spec
tion
Mea
sure
men
t rel
atin
g to
sal
e of
Com
mod
ities
Insp
ectio
n fo
r m
easu
rem
ent c
ertif
icat
ion
Reg
istr
atio
n of
mea
sure
men
t cer
tific
atio
n bu
sine
ss
Impl
emen
tatio
n of
ap
prop
riate
mea
sure
men
t
Pro
mot
ion
of
auto
nom
ous
mea
sure
men
tad
min
istr
atio
nC
ertif
ied
mea
sure
rs
Pro
per
mea
sure
men
t con
trol
bus
ines
s pl
ace
Col
lect
ion
of r
epor
ts, s
pot i
nspe
ctio
ns
(Measu
rin
g U
nit
s r
ela
tin
g t
o t
he In
tern
ati
on
al S
yste
m o
f U
nit
s)
Art
icle
3
The
mea
surin
g un
its o
f the
qua
ntiti
es o
f the
sta
te o
f phy
sica
l phe
nom
ena
enum
erat
ed in
th
e le
ft co
lum
n of
Tab
le 1
am
ong
the
quan
titie
s of
the
stat
e of
phy
sica
l phe
nom
ena
enum
erat
ed in
Par
agra
ph 1
Item
(1)
of t
he p
rece
ding
Art
icle
sha
ll be
thos
e lis
ted
in th
e rig
ht c
olum
n of
the
sam
e T
able
and
th
e d
efi
nit
ion
of
ea
ch
of
tho
se
un
its
sh
all
be
pre
scri
bed
by
Ca
bin
et
Ord
er
in a
cc
ord
an
ce
wit
h r
es
olu
tio
ns
of
the
In
tern
ati
on
al
Co
nfe
ren
ce o
f L
eg
al
Metr
olo
gy
an
d o
the
r in
tern
ati
on
al
res
olu
tio
ns
an
d p
rac
tic
es
wit
h r
eg
ard
to
me
as
uri
ng
un
its
.
(Pro
hibi
tion
of th
e U
se o
f Non
-Leg
al M
easu
ring
Uni
ts)
Art
icle
8
No
n-l
eg
al
measu
rem
en
t u
nit
ssh
all n
ot b
e us
edfo
r th
e pu
rpos
e of
tran
sact
ion
or
cert
ifica
tion
(Mea
surin
g In
stru
men
ts G
radu
ated
with
Non
-Leg
al M
easu
ring
Uni
ts)
Art
icle
9
Gra
duat
ed o
r m
arke
d w
ith n
on
-leg
al
measu
rem
en
t u
nit
ssh
all n
ot b
e so
ld o
r ex
pose
dfo
r sa
le.
Law
Law
68
Leg
al
Measu
rem
en
t
Un
it
(JA
PA
N)
SI u
nits
(Int
erna
tiona
lS
yste
m o
f Uni
t)
Non
-SI
Tab
le
Non
-SI u
nits
fo
r qu
antit
ies
wit
h n
o S
I u
nit
s
Tab
le3
Non
-SI u
nits
with
re
str
icte
d a
pp
lic
ati
on
Tab
le
Non
-SI u
nits
fo
r qu
antit
ies
for
whi
chth
ere
are
SI u
nit
s
Tab
leh
ttp
://w
ww
.nit
e.g
o.jp
/asse/jcss/e
n/s
td/in
dex.h
tml
’
“”
“”
mea
surin
g in
stru
men
t
Sp
ecif
ied
Me
as
uri
ng
in
str
um
en
t
Law
18. H
ydro
met
er-t
ype
dens
ity m
eter
s9.
Flo
w m
eter
s
17. D
ensi
tom
eter
s8.
Ane
roid
man
omet
ers
Ane
roid
Sph
ygm
oman
omet
er
16. V
ibra
tion
leve
l met
ers
7. D
ensi
ty h
ydro
met
ers
15. N
oise
met
ers
6. F
low
vel
ocity
met
ers
14. I
llum
inom
eter
s5.
Vol
ume
met
ers
13. R
eact
ive
pow
er m
eter
s4.
Mea
suri
ng m
achi
nes
of le
athe
r ar
ea
12. W
att m
eter
s3.
The
rmom
eter
s
11. M
axim
um d
eman
d en
ergy
met
ers
2. W
eigh
t met
er
10. C
alor
imet
ers
1. T
axi m
eter
s
Spec
ifie
d m
easu
ring
inst
rum
ent
(Spe
cifie
d M
easu
ring
Inst
rum
ent)
Art
icle
2 C
abin
et O
rder
’
69
Res
tric
tion
on T
rans
fer
Clin
ical
spe
cifie
d m
easu
ring
inst
rum
ents
(Res
tric
tion
on T
rans
fer,
etc
.)A
rtic
le 5
71.
An
y p
ers
on
enga
ged
in th
e bu
sine
ss o
f man
ufac
ture
, re
pair
or im
port
of c
lin
ical th
erm
om
ete
rs a
nd
oth
er
sp
ecif
ied
measu
rin
g in
str
um
en
tspr
escr
ibed
by
Cab
inet
O
rder
sh
all n
ot
tran
sfe
r o
r le
nd
su
ch
sp
ecif
ied
measu
rin
g in
str
um
en
ts t
o a
nyo
ne, o
r d
eliver
them
toth
ose
who
und
erta
ke th
e re
pair
ther
eof,
un
less t
ho
se
sp
ecif
ied
measu
rin
g in
str
um
en
ts a
re a
ffix
ed
th
e
veri
ficati
on
mark
or D
esig
nate
d m
anuf
actu
rer
Mar
k
Res
tric
tion
on T
rans
fer
1/2
Law
Art
icle
15
on C
ab
inet
Ord
er
(1)
Gla
ss c
lin
icalth
erm
omet
ers
(2)
Clin
icalre
sist
ance
ther
mom
eter
s(3
)A
ne
roid
Sp
hy
gm
om
an
om
ete
r
(Res
tric
tion
on T
rans
fer,
etc
.)A
rtic
le 5
72.
Any
per
son
enga
ged
in th
e bu
sine
ss o
f sal
eof
spe
cifie
d m
easu
ring
inst
rum
ents
pre
scrib
ed b
y C
abin
et O
rder
as
men
tione
d in
the
prec
edin
g pa
ragr
aph
(exc
ludi
ng th
ose
defin
ed in
the
prec
edin
g pa
ragr
aph)
sha
ll no
t tra
nsfe
r,
len
d, o
r p
ossess
for
the
purp
ose
of tr
ansf
errin
g or
le
ndin
g th
e sp
ecifi
ed m
easu
ring
inst
rum
ents
unl
ess
thos
e
spec
ified
mea
surin
g in
stru
men
ts a
reaf
fixed
the
verif
icat
ion
mar
k or
Des
igna
ted
man
ufac
ture
r M
ark
…
Res
tric
tion
on T
rans
fer
2/2
Law
(Res
tric
tions
on
Use
)A
rtic
le 1
6 1.
An
y o
f th
e f
ollo
win
g ite
ms s
hall n
ot
be u
sed
or
po
ssessed
for
use
with
the
purp
ose
of m
easu
rem
ents
in
lega
l mea
surin
g un
its w
hen
cond
uctin
g of
tra
nsacti
on
s
or
cert
ific
ati
on
.(1
) N
on
-measu
rin
g in
str
um
en
ts
(2)
Law
Pag
e do
wn
70
(Res
tric
tions
on
Use
)A
rtic
le 1
6 (2
)S
peci
fied
mea
surin
g in
stru
men
ts b
esid
es o
f the
fo
llow
ing:
a)
Sp
ecif
ied
measu
rin
g in
str
um
en
ts a
ffix
ed
th
e
veri
ficati
on
mark
(Mar
k) in
Art
icle
72
Par
agra
ph 1
ce
rtify
ing
the
pass
ing
of th
e ve
rific
atio
n by
the
Min
iste
r of
E
cono
my,
Tra
de a
nd In
dust
ry, o
r th
e pr
efec
ture
go
vern
or, o
r Ja
pan
Ele
ctric
Met
ers
Insp
ectio
n C
orpo
ratio
n, o
r a
pers
on d
esig
nate
d by
the
Min
iste
r of
E
cono
my,
Tra
de a
nd In
dust
ryb)
Law
Pag
e do
wn
(Res
tric
tions
on
Use
)A
rtic
le 1
6 (2
)S
peci
fied
mea
surin
g in
stru
men
ts b
esid
es o
f the
fo
llow
ing:
b)
Sp
ecif
ied
measu
rin
g in
str
um
en
ts m
an
ufa
ctu
red
by
man
ufa
ctu
rers
desig
nate
d b
y t
he M
inis
ter
of
Eco
no
my, T
rad
e a
nd
In
du
str
y a
nd
aff
ixed
th
e m
ark
(Mar
k) m
entio
ned
in A
rtic
le 9
6 P
arag
raph
1
Law
(Crit
eria
for
Qua
lific
atio
n)
Art
icle
71
1.A
spe
cifie
d m
easu
ring
inst
rum
ent p
ass
the
veri
ficati
on
insp
ectio
n w
hen
it co
nfirm
s b
oth
of
the
follo
win
g c
rite
ria:
(1)T
hestr
uctu
re(in
clud
ing
perf
orm
ance
and
mat
eria
l pr
oper
ties
co
nfo
rms t
ote
ch
nic
al
req
uir
em
en
tspr
escr
ibed
by
Ord
inan
ce o
f the
ME
TI.
(2)T
hein
str
um
en
tal err
or
do
es n
ot
exceed
th
e
tole
ran
ce o
fth
everi
ficati
on
pres
crib
ed b
y O
rdin
ance
the
ME
TI.
Law
(Crit
eria
for
Qua
lific
atio
n)
Art
icle
71
2.T
he c
onfo
rmity
to th
e P
rece
ding
Par
agra
ph It
em (
1)
shal
l be
dete
rmin
ed in
acc
orda
nce
with
pro
cedu
res
pres
crib
ed b
y O
rdin
ance
the
ME
TI..
..ho
wev
er, t
hat i
n th
e ca
se o
f ver
ifyin
g,sp
ecif
ied
measu
rin
g
instr
um
en
ts a
ffix
ed
wit
h a
decla
rati
on
un
der
Art
icle
84 P
ara
gra
ph
1, th
ey s
hall b
e r
eg
ard
ed
as
co
nfo
rmin
g t
o t
ech
nic
al
req
uir
em
en
ts…
Law
Art
icle
71
1(1)
Pag
e up
71
…
Law
Pag
e do
wn
Law
pass
pass
Veri
ficati
on
fo
r
Str
uctu
re
pass
Spe
cifie
d m
easu
rem
ent
Aff
ixed
with
Dec
lara
tion
No
Affi
xed
with
D
ecla
ratio
n
Pas
sV
erifi
catio
n
Q06
1V
eri
ficati
on
fo
r
Instr
um
en
tal err
or
Veri
ficati
on
fo
r
Instr
um
en
tal err
or
Mark
ing
of
the d
evic
e (
R16
-2 7
.4)
•nam
e an
d/or
trad
emar
k of
man
ufac
ture
r
•ser
ial n
umbe
r an
d ye
ar o
f fab
ricat
ion
•mea
surin
g ra
nge
and
mea
surin
g un
it
•typ
e ap
prov
al n
umbe
r
72
Metr
olo
gic
al re
qu
irem
en
ts
Max
imum
per
mis
sibl
e er
rors
of t
he c
uff p
ress
ure
indi
catio
n (R
16-2
5.1
) E
nviro
nmen
tal p
erfo
rman
ce
Sto
rage
(R
16-2
5.3
.1)
Tem
pera
ture
, rel
ativ
e hu
mid
ity(R
16-2
5.3
.2)
Tec
hnic
al r
equi
rem
ents
for
the
disp
lay
(R16
-2 6
.3)
Dig
ital i
ndic
atio
n (R
16-2
6.8
.2)
Effe
ct o
f vol
tage
var
iatio
ns o
f the
pow
er s
ourc
e (R
16-2
6.4
)
Inte
rnal
ele
ctric
al p
ower
sou
rce
(R16
-2 6
.4.1
) E
xter
nal e
lect
rical
pow
er s
ourc
e (R
16-2
6.4
.2)
Pne
umat
ic s
yste
m (
R16
-2 6
.5)
Zer
o se
tting
(R
16-2
6.5
.4)
Ele
ctro
mag
netic
com
patib
ility
(R
16-2
6.6
) S
tabi
lity
of th
e cu
ff pr
essu
re in
dica
tion
as p
ress
ure
( un
ique
)
73
Aut
omat
ed S
phyg
mom
anom
eter
s
Intr
od
ucti
on
Mo
de f
or
Testi
ng
Shin
ichi
BU
NR
YO
Nat
iona
l Met
rolo
gy I
nsti
tute
of
Japa
nN
MIJ
)
s.bu
nryo
u@ai
st.g
o.jp
Aut
omat
ed S
phyg
mom
anom
eter
s
Cuf
fO
IML
R16
-2
2.T
erm
inol
ogy
2.1
Bla
dd
er
Infla
tabl
e co
mpo
nent
of t
he c
uff
2.3
Cu
ffC
ompo
nent
of t
he s
phyg
mom
anom
eter
, com
pris
ing
a bl
adde
ran
d a
slee
ve, w
hich
is w
rapp
ed a
roun
d th
e lim
b of
the
patie
nt.
2.8
Sle
eve
Ess
entia
lly in
elas
tic p
art o
f the
cuf
f tha
t enc
lose
s th
e bl
adde
r
Aut
omat
ed S
phyg
mom
anom
eter
s
74
Pat
ient
Mon
itor
Aut
omat
ed S
phyg
mom
anom
eter
s
http
://w
ww
.med
rad.
com
/pro
duct
s/m
r/ve
ris-m
r-m
onito
r.ht
ml
Non
Aut
omat
ed
Sph
ygm
oman
omet
ers
Ele
ctric
al
Bas
ic C
ompo
nent
s1.
Pne
umat
icsy
stem
tran
sduc
er, p
ump,
val
ve, t
ube,
con
nect
ors
2. P
CB
( w
ith C
PU
)
3. In
dica
tion
(Dis
play
)
4. P
ower
sup
ply
5. (
Mic
roph
one
for
Aus
culta
tory
met
hod
only
)
mov
able
ele
ctro
de
Dia
phra
gm
or B
ello
ws
Bas
e
fixed
ele
ctro
de
Pre
ssur
e
Cap
acita
nce
type
pre
ssur
e se
nsor
75
Bas
ic C
ompo
nent
s
Con
trol
Val
veP
ump
Sol
enoi
dV
alve
Mic
roph
one
Tra
nsdu
cer
Pne
umat
icsy
stem
Bas
ic C
ompo
nent
s
Mod
e fo
r te
stin
g
Ref
eren
ce m
anom
eter
Tes
ted
Sph
ygm
oman
omet
er
Met
alve
ssel
Pre
ssur
ege
nera
tor
Fig
ure
Ann
exA
.2M
etr
olo
gic
al te
sti
ng
Com
parin
gas
“pr
essu
re”
Featu
re o
f M
easu
rin
g o
f N
IBP
Exh
aust
air
for
mea
surin
g of
BP
Tra
nsdu
cer
Cuf
f
pum
p
Val
ve
Air
pres
sure
Pne
umat
icsy
stem
Mod
e fo
r te
stin
g
Par
ticul
ar to
ols
pum
p
Val
ve
Air
pres
sure
Pne
umat
icsy
stem
Tra
nsdu
cer
Par
ticul
ar p
lug
Tra
nsdu
cer
76
Mod
e fo
r te
stin
g w
ith p
artic
ular
plu
gs
part
icul
ar p
lugs
Ref
eren
ce m
anom
eter
Tes
ted
Sph
ygm
oman
omet
er
Met
alve
ssel
Pre
ssur
ege
nera
tor
Fig
ure
ofA
nnex
A.2
Bas
icco
nnec
tion
for
test
ing
Mod
e fo
r te
stin
g
Dire
ctly
con
nect
ing
to p
ress
ure
sens
or
77
WE
LC
OM
E T
O E
TC
APL
MF
Sem
inar
AP
LMF
Exe
cutiv
e S
ecre
tary
-D
r. T
suyo
shi M
atsu
mot
o
PT
B -
Dr.
Ste
phan
Mie
ke(P
TB
)N
MIJ
-M
r. S
hini
chi B
unry
ou(N
MIJ
)(B
SM
I) -
Age
nda
clos
e11
:00
Tes
t dem
onst
ratio
n an
d op
inio
n ex
chan
ge10
2011
:00
ET
CLa
bora
tory
brie
f tou
r10
0010
:20
OIM
L R
16-
2E
MC
OIM
L R
16-
2te
st it
ems
revi
ew
920
10:0
0
ET
CB
rief i
ntro
duct
ion
of E
TC
900
9:20
Wel
com
e sp
eech
by
Pre
side
nt W
ang
850
9:00
Arr
ive
ET
C8
50
Con
tent
Tim
e(20
th,J
uly)
ET
C B
rief
Pors
onFu
Med
ical
Equ
ipm
ent G
roup
of
Prod
uct S
afet
y T
estin
g D
epar
tmen
t, T
aiw
an
Bac
kgro
und
ET
C, S
ince
198
3, t
he E
TC
was
pre
viou
sly
one
divi
sion
of
Ele
ctro
nics
Res
earc
h an
d Se
rvic
e O
rgan
izat
ion
(E
RSO
) of
IT
RI.
In
1983
, the
M
inis
try
of E
cono
mic
Aff
airs
, Ind
ustr
ial
Tec
hnol
ogy
Res
earc
h In
stit
ute,
Tai
wan
Ele
ctri
cal
and
Ele
ctro
nic
Man
ufac
ture
r’s
Ass
ocia
tion
, and
pu
blic
ent
erpr
ises
col
lect
ivel
y pr
omot
ed t
he
esta
blis
hmen
t of
the
ET
C.
78
Pri
mar
y O
bjec
tive
s
The
ETC w
as f
ounded
to p
rovi
de
pro
duct
in
spec
tion a
nd r
egis
trat
ion s
ervi
ces,
as
wel
l as
ai
d in t
he
dev
elopm
ent
of
qual
ity
contr
ol an
d insp
ection t
echnolo
gy.
In
additio
n,
the
ETC s
triv
es t
o im
pro
ve loca
l pro
duct
qual
ity
and p
rosp
erity
in t
he
indust
ry,
and f
ight
for
the
public
ben
efit.
Org
aniz
atio
n C
hart
Bo
ard
of
Dir
ecto
rs
Pre
sid
en
t’s
off
ice
Bo
ard
of
Su
pe
rvis
ors
Au
dit
or’
s
off
ice
Measu
rem
en
t &
Calib
rati
on
Tech
no
log
y D
ep
t.
Measu
rem
en
t &
Calib
rati
on
Tech
no
log
y D
ep
t.
Cert
ific
ati
on
Dep
t.C
ert
ific
ati
on
Dep
t.
Co
mm
un
icati
on
T
ech
no
log
y
Dep
t.
Co
mm
un
icati
on
T
ech
no
log
y
Dep
t.
Ele
ctr
on
ics T
esti
ng
Dep
t .E
lectr
on
ics T
esti
ng
Dep
t.
Ele
ctr
om
ag
neti
c C
om
pati
bilit
y
Testi
ng
Dep
t.
Ele
ctr
om
ag
neti
c C
om
pati
bilit
y
Testi
ng
Dep
t.
Ele
ctro
mag
neti
c C
ompa
tibi
lity
T
esti
ngD
ep
t.
Ele
ctro
mag
neti
c C
ompa
tibi
lity
T
esti
ngD
ep
t.
En
vir
on
men
tal p
rote
cti
on
&
Ind
ustr
ial S
afe
ty H
yg
ien
e D
ep
t.
En
vir
on
men
tal p
rote
cti
on
&
Ind
ustr
ial S
afe
ty H
yg
ien
e D
ep
t.
Man
ag
em
en
t C
on
su
ltin
g D
ep
t.M
an
ag
em
en
t C
on
su
ltin
g D
ep
t.
Pro
du
cts
Safe
ty T
esti
ng
Dep
t.P
rod
ucts
Safe
ty T
esti
ng
Dep
t.
Acco
un
tin
g D
ep
t.
Pla
nn
ing
&
Tech
nic
al M
ark
eti
ng
Dep
t.
Ad
min
istr
ati
on
Dep
t.
Qua
lity
Pol
icy
To p
urs
ue
exce
llence
in s
ervi
ce
qual
ity
with a
ded
icat
ed w
ork
ing
attitu
de.
Num
ber
of E
mpl
oyee
s in
Pas
t Y
ears
Em
ploy
ees:
302
in 2
006
79
Pri
mar
ySe
rvic
es(1
)P
rod
uct
Test
ing
Serv
ices
Pro
du
ct S
afe
ty T
est
s EM
C T
est
sFu
nct
ion &
Rel
iabili
ty T
ests
Tes
ting a
nd V
erific
atio
n o
f Tel
ecom
munic
atio
n
Ter
min
al E
quip
men
tEnvi
ronm
enta
l La
bel
/ E
ner
gy
Eff
icie
ncy
Tes
tsChem
ical
Anal
ysis
for
Res
tric
tion o
f H
azar
dous
Subst
ance
s (R
oH
S)
Insp
ection a
nd T
ype
Tes
ting o
f Le
gal
Mea
suring
Inst
rum
ents
Pri
mar
y Se
rvic
es(2
)
Pro
du
cts
Cert
ific
ati
on
serv
ices
Inst
rum
en
t an
d E
qu
ipm
en
t C
ali
bra
tio
nC
on
sult
ing
Serv
ice
Qual
ity
Man
agem
ent
Sys
tem
Envi
ronm
enta
l M
anag
emen
t Sys
tem
Inte
llect
ual
Pro
per
ty R
ights
Man
agem
ent
Sys
tem
Tra
inin
g o
f P
rofe
ssio
nal
Tech
no
log
y
Pro
duct
Saf
ety
Tes
ts
Test
ing
Fie
lds
Test
ing
Fie
lds
BSM
I,BSM
I,G
SG
S,
PSE,
S,
, PS
E,
S,
CE
CE
,,U
LU
L , C
SA,
FIM
KO
, N
EM
KO
, SEM
KO
, ,
CSA,
FIM
KO
, N
EM
KO
, SEM
KO
, an
d D
EM
KO
, CB e
tc.
and D
EM
KO
, CB e
tc.
Our
safe
ty t
esting lab
has
bee
n a
ppro
ved b
y IE
CEE a
nd
Our
safe
ty t
esting lab
has
bee
n a
ppro
ved b
y IE
CEE a
nd
bee
n r
egis
tere
d in t
hei
r CBTL
list.
bee
n r
egis
tere
d in t
hei
r CBTL
list.
We
could
iss
ue
CB r
eport
s on I
EC 6
0065 &
IEC 6
0950.
We
could
iss
ue
CB r
eport
s on I
EC 6
0065 &
IEC 6
0950.
Tes
ting
Sta
ndar
d P
rodu
cts
IEC 6
0745:
Ele
ctric
Tools
IEC 6
0320:
Pow
er C
ord
Ass
embly
IEC 6
1058:
Pow
er S
witch
IEC 6
0065:
AV P
roduct
sIE
C 6
0335:
Hom
e Applia
nce
sIE
C 6
0950:
IT P
roduct
sIE
C 6
0958:
Lighting
IEC
60
60
1:
Med
ical
Ele
ctri
cal
Eq
uip
men
t
Pro
duct
Saf
ety
Tes
tsP
rodu
ct S
afet
y T
ests
80
Ele
ctro
mag
neti
c C
ompa
tibi
lity
(EM
C)
Tes
tsP
rod
uct
s:P
rod
uct
s:M
edic
al E
quip
men
t(M
E),
IT,
Wire
& W
irel
ess
Com
munic
atio
n,
Med
ical
Equip
men
t(M
E),
IT,
Wire
& W
irel
ess
Com
munic
atio
n,
Multim
edia
, H
om
e Applia
nce
s, L
ighting,
Pow
er T
ools
, Lo
wM
ultim
edia
, H
om
e Applia
nce
s, L
ighting,
Pow
er T
ools
, Lo
w--
Pow
er/F
requen
cy D
evic
esPo
wer
/Fre
quen
cy D
evic
es
Test
ing
Sta
nd
ard
s:Test
ing
Sta
nd
ard
s:-E
MI
Test
ing
(IEC 5
55-2
/-3)
-EM
S T
est
ing
(IEC 8
01-2
~-6
, IE
C 6
1000 )
-SAR
Test
ing
Fie
lds:
Test
ing
Fie
lds:
-- Dom
estic
is A
ppro
ved b
y BSM
I an
d N
CC
Dom
estic
is A
ppro
ved b
y BSM
I an
d N
CC
--Fo
reig
n a
gen
cies
incl
udin
g th
e FC
C o
f Am
eric
a ,
the
Fore
ign a
gen
cies
incl
udin
g th
e FC
C o
f Am
eric
a ,
the
Euro
pea
n N
otified
Bodie
s, C
Euro
pea
n N
otified
Bodie
s, C
-- Stick
of Aust
ralia
and t
he
Stick
of Aust
ralia
and t
he
VCCI
VCCI
of Ja
pan
of Ja
pan
..--
CB R
eport
sCB R
eport
s
Insp
ecti
on a
nd T
ype
Tes
ting
of
Insp
ecti
on a
nd T
ype
Tes
ting
of
Leg
al M
easu
ring
Ins
trum
ents
Leg
al M
easu
ring
Ins
trum
ents
Insp
ect
ion
Ite
ms
Insp
ect
ion
Ite
ms
-- Nois
e m
eter
s,
Nois
e m
eter
s,
-- Rad
ar S
pee
d D
etec
tors
, Rad
ar S
pee
d D
etec
tors
, -- V
ehic
le E
xhau
st A
nal
yzer
s,
Veh
icle
Exh
aust
Anal
yzer
s,
-- Bre
ath A
lcohol Tes
ters
and A
nal
yzer
s,
Bre
ath A
lcohol Tes
ters
and A
nal
yzer
s,
-- Illu
min
atio
n P
hoto
met
ers.
Illu
min
atio
n P
hoto
met
ers.
Typ
e T
est
ing
Ite
ms
Typ
e T
est
ing
Ite
ms
Illu
min
atio
n P
hoto
met
ers,
Ele
ctro
nic
Sca
les,
Tax
i Illu
min
atio
n P
hoto
met
ers,
Ele
ctro
nic
Sca
les,
Tax
i Fe
e M
eter
sFe
e M
eter
s
ET
C A
s A
ccre
dite
d P
rodu
ct C
erti
fica
tion
Org
aniz
atio
n
APE
C M
RA A
ccre
dited
and R
egis
tere
d
Tel
ecom
munic
atio
n T
erm
inal
Equip
men
t Cer
tifica
tion O
rgan
izat
ion
RO
C T
AF
accr
edited
Tel
ecom
munic
atio
n T
erm
inal
Equip
men
t Cer
tifica
tion O
rgan
izat
ion
Nat
ional
Com
munic
atio
ns
Com
mis
sion (
NCC),
M
inis
try
of
Tra
nsp
ort
atio
n a
nd C
om
munic
atio
ns
(MO
TC)
Acc
redited
Tel
ecom
munic
atio
n T
erm
inal
Equip
men
t Cer
tifica
tion O
rgan
izat
ion
Pro
duct
Cer
tifica
tion O
rgan
izat
ion A
ppro
ved b
y H
ong K
ong S
pec
ial Adm
inis
trat
ive
Reg
ion E
lect
rica
l an
d M
echan
ical
Ser
vice
s D
epar
tmen
t
Cer
tifi
cati
ons
and
Issu
ing
Inst
itut
es
ISO
9001 /
BSM
I &
TÜ
V-S
ÜD
Hea
dquar
ters
ISO
14001 /
TÜ
V-S
ÜD
JQA /
Jap
an
FIM
KO
/ F
inla
nd
TÜ
V-S
ÜD
, V
DE /
Ger
man
y
CN
AL
/ Chin
a
NCC,
TAF
/ Tai
wan
CBTL
/ IE
CEE
Product
Saf
ety
Labora
tory
Indust
rial
Dev
elopm
ent
Bure
au,
MO
EA
Envi
ronm
enta
lM
anag
emen
t Ass
ista
nce
In
stitute
Cer
tifica
te I
ssuin
g
Inst
itution
Our
Tes
ting L
ab
81
Cer
tifi
cati
ons
and
Iss
uing
Ins
titu
tes
VCCI
/ Ja
pan
NEM
KO
/ N
orw
ayFI
MKO
/ F
inla
nd
IC /
Can
ada
FCC,
NVLA
P ,
UL
/ U
SA
TÜ
V-S
ÜD
, T
ÜV-R
hei
nla
nd
/ G
erm
any
BSM
I,TAF,
NCC /
Tai
wan
CBTL
/ IE
CEE
EM
C T
esting
Labora
tory
Cer
tifica
te I
ssuin
g
Inst
itution
Our
Tes
ting L
ab
Inte
rnat
iona
l Col
labo
ratio
n
United
Sta
tes
United
Sta
tes
UL,
USB
UL,
USB
-- IF,
IEEE
1394TA,
IF,
IEEE
1394TA,
MO
TO
RO
LAM
OTO
RO
LAJa
pan
Japan
JQA
JQA
,,JA
TE
JATE,,
VCCI
VCCI ,,
JET
JET
Ger
man
yG
erm
any
TTÜÜ
VV--
SSÜÜ
DD,,
VD
EVD
EFi
nla
nd
Finla
nd
FIM
KO
FI
MKO
N
orw
ayN
orw
ayN
EM
KO
NEM
KO
Engla
nd
Engla
nd
BABT
BABT,
NPL
, N
PL
Net
her
lands
Net
her
lands
TN
OTN
OCan
ada
Can
ada
Mar
stec
hM
arst
ech
Chin
aChin
aCQ
C,
CEM
C,
Tai
CQ
C,
CEM
C,
Tai
-- Er
Er
Labora
tory
Labora
tory
Serv
ice
Dep
artm
ents
and
Lab
orat
orie
s
Hea
dquar
ters
(Tao
yuan
Guis
han
Linko
u-
Gong-S
an I
ndust
rial
Par
k)Li
nko
uLa
b
(Lin
kou
Din
gfu
Vill
age)
Hsi
nch
uLa
b (
Hsi
nch
uSci
ence
Par
k)Tai
chung
Lab(T
aich
ung
Indust
rial
Par
k)Tai
nan
Lab (
Anpin
gIn
dust
rial
Par
k)
Non
-inv
asiv
e A
utom
ated
Sp
hygm
oman
omet
ers
Typ
e T
estin
g
82
NIB
P T
estin
g A
ccor
ding
to O
IML
R16
-2
Product
Saf
ety
Tes
ting?
(IEC 6
0601-1
:2005)
EM
C (
Ele
ctro
Mag
net
icCom
pat
ibili
ty)
Tes
ting
(IEC 6
0601-1
-2:
2001)
Res
ista
nce
to V
ibra
tion a
nd S
hock
(OIM
L R16-2
: 2002)
NIB
P Pe
rform
ance
Tes
ting (
OIM
L R16-2
: 2002)
OIM
L R
16-2
: Saf
ety
6.1
1 S
afet
y•
6.1
1.1
Cuff p
ress
ure
It s
hal
l be
poss
ible
to a
bort
any
blo
od p
ress
ure
mea
sure
men
t at
any
tim
e by
single
key
oper
atio
n a
nd t
his
shal
l le
ad t
o
rapid
exh
aust
.
•6.1
1.2
Unau
thorize
d a
cces
sAll
contr
ols
that
affec
t ac
cura
cy s
hal
l be
seal
ed a
gai
nst
unau
thorize
d a
cces
s.
•6.1
1.3
Tubin
g c
onnec
tors
To a
void
connec
ting t
he
outp
ut
of th
e blo
od p
ress
ure
m
easu
ring d
evic
e to
such
sys
tem
s as
air m
ight
inad
vert
ently
be
pum
ped
into
a b
lood v
esse
l. L
uer
lock
connec
tions
shal
l not
be
use
d.
•6.1
1.4
Ele
ctri
cal sa
fety
Ele
ctro
nic
or
auto
mat
ed s
phyg
mom
anom
eter
s sh
all co
mply
w
ith t
he
rele
vant
nat
ional
saf
ety
regula
tions.
IEC
60
60
1-1
IEC
606
01S
erie
s:
Med
ical
Ele
ctric
al E
quip
men
t
Red
: Gen
eral
Req
uire
men
ts
Gre
en: (
perp
endi
cula
r) P
artic
ular
Req
uire
men
tsB
lue:
(pa
ralle
l) C
olla
tera
l Sta
ndar
d
IEC
606
01-1
IEC
606
01-1
-2IE
C 6
0601
-1-1
IEC
606
01-1
-8
IEC
606
01-2
-01
IEC
606
01-2
-30
IEC
606
01-2
-51
IEC
606
01S
erie
s:
Med
ical
Ele
ctric
al E
quip
men
tIE
C 6
0601
IEC 6
0601-- 1
: G
ener
al r
equirem
ents
for
safe
ty1:
Gen
eral
req
uirem
ents
for
safe
tyIE
C 6
0601
IEC 6
0601-- 11
-- 2:
Ele
ctro
mag
net
ic c
om
pat
ibili
ty
2:
Ele
ctro
mag
net
ic c
om
pat
ibili
ty
requirem
ent
and t
est
requirem
ent
and t
est
IEC 6
0601
IEC 6
0601-- 22
-- 30:
Auto
mat
ic c
yclin
g n
on
30:
Auto
mat
ic c
yclin
g n
on--
inva
sive
blo
od p
ress
ure
monitoring e
quip
men
tin
vasi
ve b
lood p
ress
ure
monitoring e
quip
men
tIE
C 6
0601
IEC 6
0601-- 11
-- 1:
Saf
ety
requirem
ents
for
1:
Saf
ety
requirem
ents
for
med
ical
sys
tem
sm
edic
al s
yste
ms
IEC 6
0601
IEC 6
0601-- 11
-- 4:
Progra
mm
able
ele
ctrica
l 4:
Progra
mm
able
ele
ctrica
l m
edic
al s
yste
ms
med
ical
sys
tem
s
83
Non
-inv
asiv
e A
utom
ated
Sp
hygm
oman
omet
ers
Tes
ting
IEC 6
0601-1
IEC 6
0601-1
-2O
IML
R16-2
IEC
606
01-1
: Cla
ssifi
catio
n(1)
Cla
ssific
atio
n o
f pow
er s
ourc
e•
Cla
ss I
Eq
uip
men
t -
Use
s PE
as
1 L
OP.
•C
lass
I E
qu
ipm
en
t (a
lso k
now
n a
s D
ouble
Insu
late
d)
-D
oes
not
use
PE a
s 1 L
OP.
•In
tern
ally
pow
ered
equip
men
tD
efin
itio
n a
pplie
d p
arts
: P
art o
f me
equi
pmen
t tha
t in
norm
al u
se
nece
ssar
ily c
omes
into
phy
sica
l con
tact
with
the
patie
nt
Cla
ssific
atio
n o
f ap
plie
d p
arts
: th
e deg
ree
of
pro
tect
ion a
gai
nst
ele
ctric
shock
B<
BF<
CF
•Typ
e B A
pplie
d P
art
•F-
Typ
e Is
ola
ted (
Float
ing)
Applie
d P
art
Typ
e BF
Applie
d P
art
Typ
e CF
Applie
d P
art:
Direc
t ca
rdia
c ap
plic
atio
n1k
curr
ent
FF-- T
ype
(BF
/CF
) A
pplie
d pa
rts
Typ
e (B
F/C
F)
App
lied
part
s
LO
P=
Level
of
pro
tect
ion
Ap
plied
part
IEC
606
01-1
: Cla
ssifi
catio
n(2)
Cla
ssific
atio
n o
f Equip
men
t O
per
atio
n M
ode
•Continuous
Oper
atio
n•
Short
-tim
e O
per
atio
n•
Inte
rmitte
nt
Oper
atio
n•
Continuous
Oper
atio
n w
ith S
hort
-tim
e Lo
adin
g•
Continuous
Oper
atio
n w
ith I
nte
rmitte
nt
Load
ing
Cla
ssific
atio
n o
f ap
plic
atio
n w
ith F
lam
mab
le A
nae
sthet
ic•
Equip
men
t not
suitab
le for
use
with fla
mm
able
anae
sthet
ic•
Cat
egory
AP
Equip
men
t•
Cat
egory
APG
Equip
men
tCla
ssific
atio
n A
gai
nst
Ingre
ss o
f Li
quid
s•
Drip-p
roof Equip
men
tIP
X1
•Spla
sh-p
roof Equip
men
tIP
X4
•W
ater
tight
Equip
men
tIP
X7
84
IEC
606
01IE
C 6
0601
-- 1: H
azar
ds1:
Haz
ards
Prote
ctio
n a
gai
nst
ele
ctric
Prote
ctio
n a
gai
nst
ele
ctric
shock
haz
ards
shock
haz
ards
Prote
ctio
n a
gai
nst
Pr
ote
ctio
n a
gai
nst
mec
han
ical
haz
ards
mec
han
ical
haz
ards
Prote
ctio
n a
gai
nst
Pr
ote
ctio
n a
gai
nst
exc
essi
ve r
adia
tion
exce
ssiv
e ra
dia
tion
Prote
ctio
n a
gai
nst
Pr
ote
ctio
n a
gai
nst
fla
mm
able
flam
mab
lean
aest
het
ican
aest
het
ichaz
ard
haz
ard
Prote
ctio
n a
gai
nst
Pr
ote
ctio
n a
gai
nst
exc
essi
ve t
emper
ature
sex
cess
ive
tem
per
ature
sPr
ote
ctio
n a
gai
nst
Pr
ote
ctio
n a
gai
nst
fire
haz
ards
fire
haz
ards
Prote
ctio
n a
gai
nst
Pr
ote
ctio
n a
gai
nst
abnorm
al o
per
atio
n a
nd
abnorm
al o
per
atio
n a
nd
fault h
azar
ds
fault h
azar
ds
Stru
ctur
e
Product
Saf
ety
Tes
ting
EM
C (
Ele
ctro
Mag
net
icCom
pat
ibili
ty)
Tes
ting?
Res
ista
nce
to V
ibra
tion a
nd S
hock
(O
IML
R16-2
: 2002)
NIB
P Pe
rform
ance
Tes
ting
OIM
L R
16-2
: EM
C6.6
Ele
ctro
mag
net
ic c
om
pat
ibili
ty6.6
Ele
ctro
mag
net
ic c
om
pat
ibili
tyEither
Either
••Ele
ctrica
l an
d/o
r el
ectr
om
agnet
ic inte
rfer
ence
s sh
all not
Ele
ctrica
l an
d/o
r el
ectr
om
agnet
ic inte
rfer
ence
s sh
all not
lead
to d
egra
dat
ions
in t
he
cuff p
ress
ure
indic
atio
n o
r in
le
ad t
o d
egra
dat
ions
in t
he
cuff p
ress
ure
indic
atio
n o
r in
th
e re
sult o
f th
e blo
od p
ress
ure
the
resu
lt o
f th
e blo
od p
ress
ure
Or
Or ••
If e
lect
rica
l an
d/o
r el
ectr
om
agnet
ic inte
rfer
ence
s le
ad t
o
If e
lect
rica
l an
d/o
r el
ectr
om
agnet
ic inte
rfer
ence
s le
ad t
o
an a
bnorm
ality,
the
abnorm
ality
shal
l be
clea
rly
indic
ated
an
abnorm
ality,
the
abnorm
ality
shal
l be
clea
rly
indic
ated
an
d it
shal
l be
poss
ible
to r
esto
re n
orm
al o
per
atio
n w
ithin
an
d it
shal
l be
poss
ible
to r
esto
re n
orm
al o
per
atio
n w
ithin
30s
afte
r ce
ssat
ion o
f th
e el
ectr
om
agnet
ic d
istu
rban
ce.
30s
afte
r ce
ssat
ion o
f th
e el
ectr
om
agnet
ic d
istu
rban
ce.
Tes
ting s
hal
l co
mply
with I
EC 6
0601
Tes
ting s
hal
l co
mply
with I
EC 6
0601-- 11
-- 22
Acc
ordi
ng to
IE
C 6
0601
-1-2
EM
C=
EM
I (I
nte
rfer
ence
) +
EM
S (
Susc
eptibili
ty)
EM
C=
EM
I (I
nte
rfer
ence
) +
EM
S (
Susc
eptibili
ty)
EM
IE
MS
85
EM
I Tes
t Ite
ms
EM
I Tes
t Ite
ms
RF
emis
sions
(com
ply
with C
ISPR
11)
RF
emis
sions
(com
ply
with C
ISPR
11)
Har
monic
em
issi
ons
(IEC 6
1000
Har
monic
em
issi
ons
(IEC 6
1000-- 33
-- 2)
2)
Flic
ker
emis
sions
(IEC 6
1000
Flic
ker
emis
sions
(IEC 6
1000-- 33
-- 3)
3)
RF
Em
issi
ons
Tes
ting
site
RF
Em
issi
ons
Tes
ting
site
9m
* 6
m *
6m
(EM
I Sem
i9m
* 6
m *
6m
(EM
I Sem
i --Anec
hoic
Cham
ber
)Anec
hoic
Cham
ber
)Tes
ting s
hal
l be
carr
ied o
ut
in a
ccord
ance
with C
ISPR
11
Tes
ting s
hal
l be
carr
ied o
ut
in a
ccord
ance
with C
ISPR
11
EM
S T
est I
tem
sE
MS
Tes
t Ite
ms
ESD
(Ele
ctro
stat
ic D
isch
arge)
ESD
(Ele
ctro
stat
ic D
isch
arge)
••6 k
V c
onta
ct;
6 k
V c
onta
ct;
8 k
V a
ir8 k
V a
ir
EFT
(Ele
ctrica
l Fa
st T
ransi
ent)
EFT
(Ele
ctrica
l Fa
st T
ransi
ent)
••2 k
V f
or
pow
er s
upply
lin
es;
2 k
V f
or
pow
er s
upply
lin
es;
••1 k
V f
or
input/
outp
ut
lines
1 k
V f
or
input/
outp
ut
lines
Surg
eSurg
e••
1 k
V lin
e to
lin
e;
1 k
V lin
e to
lin
e;
2 k
V lin
e to
ear
th2 k
V lin
e to
ear
th
Voltag
e D
ips
Voltag
e D
ips
Conduct
ed R
F im
munity
Conduct
ed R
F im
munity
Rad
iate
d im
munity
Rad
iate
d im
munity
EM
S: R
adia
ted
Imm
unity
EM
S: R
adia
ted
Imm
unity
For
non life–
support
ing
equip
men
t Sig
nal
Gen
erat
ion A
nte
nna:
Fr
equen
cy=
80 M
Hz~
2.5
GH
zPo
wer
=3V/m
86
Stru
ctur
e
Product
Saf
ety
Tes
ting
EM
C(E
lect
roM
agnet
icCom
pat
ibili
ty)
Tes
ting
Res
ista
nce
to V
ibra
tion a
nd S
hock
(O
IML
R16-2
: 2002)
NIB
P Pe
rform
ance
Tes
ting
Res
ista
nce
to V
ibra
tion
and
Sho
ck
6.1
1.5
6.1
1.5
••The
sphyg
mom
anom
eter
s sh
all co
mply
The
sphyg
mom
anom
eter
s sh
all co
mply
w
ith t
he
rele
vant
pro
visi
ons
of
OIM
L w
ith t
he
rele
vant
pro
visi
ons
of
OIM
L D
11:2
004.
D11:2
004.
Note
: Aft
er t
esting t
he
dev
ice
shal
l co
mply
with
Note
: Aft
er t
esting t
he
dev
ice
shal
l co
mply
with
the
requirem
ents
of
5.1
: th
e re
quirem
ents
of
5.1
: M
axim
um
per
mis
sible
M
axim
um
per
mis
sible
er
rors
of
the
cuff
pre
ssure
indic
atio
ner
rors
of
the
cuff
pre
ssure
indic
atio
n..
Stru
ctur
e
Product
Saf
ety
Tes
ting
EM
C(E
lect
roM
agnet
icCom
pat
ibili
ty)
Tes
ting
Res
ista
nce
to V
ibra
tion a
nd S
hock
(O
IML
R16-2
: 2002)
NIB
P Pe
rform
ance
Tes
ting
NIB
P P
erfo
rman
ce T
estin
gM
axim
um
per
mis
sible
err
ors
of th
e cu
ff p
ress
ure
indic
atio
nM
axim
um
per
mis
sible
err
ors
of th
e cu
ff p
ress
ure
indic
atio
n••
Err
or
Err
or
3 m
mH
g in t
he
firs
t tim
e re
adin
g/5
0 m
mH
g a
ste
p3 m
mH
g in t
he
firs
t tim
e re
adin
g/5
0 m
mH
g a
ste
p••
Err
or
Err
or
4 m
mH
g in u
se4 m
mH
g in u
seAppar
atus
Appar
atus
••Rig
id m
etal
ves
sel 500 m
l Rig
id m
etal
ves
sel 500 m
l 5%
5%
••Cal
ibra
ted r
efer
ence
man
om
eter
with a
n u
nce
rtai
nty
les
s th
an 0
.8Cal
ibra
ted r
efer
ence
man
om
eter
with a
n u
nce
rtai
nty
les
s th
an 0
.8m
mH
gm
mH
g••
Pres
sure
gen
erat
or
Pres
sure
gen
erat
or
••TT-- p
iece
connec
tors
and h
ose
spie
ce c
onnec
tors
and h
ose
s
87
Effe
ct o
f vol
tage
var
iatio
ns o
f the
pow
er s
ourc
eE
ffect
of v
olta
ge v
aria
tions
of t
he p
ower
sou
rce
Inte
rnal
pow
er s
upply
reg
ula
tion in s
teps
of 0.1
VIn
tern
al p
ow
er s
upply
reg
ula
tion in s
teps
of 0.1
VAt
the
low
est
voltag
e lim
it incr
ease
d b
y 0.1
V a
nd a
lso a
t th
e At
the
low
est
voltag
e lim
it incr
ease
d b
y 0.1
V a
nd a
lso a
t th
e nom
inal
voltag
e nom
inal
voltag
e Appar
atus
Appar
atus
••Adju
stab
le d
irec
t cu
rren
t vo
ltag
e su
pply
Adju
stab
le d
irec
t cu
rren
t vo
ltag
e su
pply
••Voltm
eter
with a
n u
nce
rtai
nty
of le
ss t
han
0.5
% o
f th
e m
easu
red
Voltm
eter
with a
n u
nce
rtai
nty
of le
ss t
han
0.5
% o
f th
e m
easu
red v
alue
valu
e••
Cal
ibra
ted r
efer
ence
man
om
eter
with a
n u
nce
rtai
nty
of le
ss t
han
Cal
ibra
ted r
efer
ence
man
om
eter
with a
n u
nce
rtai
nty
of le
ss t
han
0.8
mm
Hg
0.8
mm
Hg
Note
: Add t
he
hig
h r
esolu
tion D
C p
ow
er m
eter
for
monitoring
Note
: Add t
he
hig
h r
esolu
tion D
C p
ow
er m
eter
for
monitoring
voltag
e fluct
uat
ion
voltag
e fluct
uat
ion
DC
su
pp
lyD
C p
ow
er
mete
r
Zer
o se
tting
Zer
o se
tting
Appar
atus
Appar
atus
••Rig
id m
etal
ves
sel 500 m
l Rig
id m
etal
ves
sel 500 m
l 5%
5%
••Cal
ibra
ted r
efer
ence
man
om
eter
with a
n u
nce
rtai
nty
les
s th
an 0
.8Cal
ibra
ted r
efer
ence
man
om
eter
with a
n u
nce
rtai
nty
les
s th
an 0
.8m
mH
gm
mH
g••
Pres
sure
gen
erat
or
Pres
sure
gen
erat
or
••TT-- p
iece
connec
tors
and h
ose
spie
ce c
onnec
tors
and h
ose
sPr
oce
dure
Proce
dure
Init
iate
zero
se
ttin
g a
t
+6
mm
Hg
0 m
mH
g
-6 m
mH
g
10
0m
mH
g
10
0m
mH
g
10
0m
mH
g
+1
06
mm
Hg
10
0 m
mH
g
-94
mm
Hg
Infl
ati
on
se
ttin
g a
t
TH
AN
KS
FOR
YO
UR
A
TT
EN
TIO
N
88
Ch
an
gC
han
g-- C
hyi
Ch
yi
Lin
MD
, Ph
DLin
MD
, Ph
D
1975
1975
-- 198
2
MD
; N
DM
C19
82
MD
; N
DM
C19
8219
82-- 1
986
In
tern
al M
edic
ine
Res
iden
cy19
86
Int
erna
l Med
icin
e Res
iden
cy19
8619
86-- 1
990
Ph
D;
Duk
e U
nive
rsity
1990
P
hD;
Duk
e U
nive
rsity
1990
1990
-- 199
2
Inte
rnal
Med
icin
e Res
iden
cy19
92
Int
erna
l Med
icin
e Res
iden
cy19
9219
92-- 1
994
Ca
rdio
logy
Fel
low
ship
1994
C
ardi
olog
y Fe
llow
ship
1994
1994
-- 200
5 Ca
rdio
logy
Att
endi
ng;
TSG
H20
05 C
ardi
olog
y At
tend
ing;
TSG
H20
0520
05--
Card
iolo
gy C
onsu
ltant
; CS
MC
Card
iolo
gy C
onsu
ltant
; CS
MC
1992
1992
--As
soci
ate
Prof
esso
r, M
edic
ine
Asso
ciat
e Pr
ofes
sor,
Med
icin
e
NIB
P m
on
ito
rN
IBP m
on
ito
r-- V
iew
fro
m C
ard
iolo
gis
t in
pra
ctic
eV
iew
fro
m C
ard
iolo
gis
t in
pra
ctic
e
Chan
gC
han
g-- C
hyi
Chyi
Lin
MD
, Ph
DLi
n
MD
, Ph
D
Wh
at
is B
PW
hat
is B
P
Forc
e of
blo
od o
n ar
teria
l wal
l.Fo
rce
of b
lood
on
arte
rial w
all.
BP p
att
ern
sBP p
att
ern
s
89
Wh
at
Wh
at ’’
s re
gu
lati
ng
BP
s re
gu
lati
ng
BP
Wh
y B
P i
s im
po
rtan
tW
hy B
P i
s im
po
rtan
t
BP is
an
impo
rtan
t in
dica
tor
BP is
an
impo
rtan
t in
dica
tor
for
card
iova
scul
ar &
ove
rall
for
card
iova
scul
ar &
ove
rall
heal
thhe
alth
Rou
tine
task
Rou
tine
task
––O
ften
car
ried
out
by t
he le
ast
trai
ned,
O
ften
car
ried
out
by t
he le
ast
trai
ned,
lo
w p
riorit
ylo
w p
riorit
y––
Less
QC
in e
quip
men
t se
lect
ion,
Le
ss Q
C in
equ
ipm
ent
sele
ctio
n,
calib
ratio
n, r
epai
r, p
erso
nnel
tra
inin
g ca
libra
tion,
rep
air,
per
sonn
el t
rain
ing
& p
erfo
rman
ce e
valu
atio
n&
per
form
ance
eva
luat
ion
Hyp
ert
en
sio
nH
yp
ert
en
sio
n––
the f
ocu
sth
e f
ocu
sJN
C 7
Defi
nit
ion
JNC
7 D
efi
nit
ion
<80
<80
and
and
<12
0<
120
Nor
mal
Nor
mal
8080–– 8
989oror
120
120 ––
139
139
Preh
yper
tens
ion
Preh
yper
tens
ion
9090–– 9
999oror
140
140 ––
159
159
Stag
e 1
Stag
e 1
Hyp
erte
nsio
nH
yper
tens
ion
>>10
010
0oror
>>16
016
0St
age
2 St
age
2 H
yper
tens
ion
Hyp
erte
nsio
n
DB
PD
BP
mm
Hg
mm
Hg
SBP
SBP
mm
Hg
mm
Hg
BP
BP
Cla
ssif
icat
ion
Cla
ssif
icat
ion
90
ESC
Defi
nit
ion
ESC
Defi
nit
ion
<90
<90
>>14
014
0Sy
stol
ic H
yper
tens
ion
>>11
011
0>>
180
180
Stag
e 3
Hyp
erte
nsio
n (S
ever
e)
100
100 --
109
109
160
160 --
179
179
Stag
e 2
Hyp
erte
nsio
n (M
oder
ate)
9090-- 9
99914
014
0 --15
915
9St
age
1 H
yper
tens
ion
(Mild
)
8585-- 8
98913
013
0 --13
913
9H
igh
Nor
mal
8080-- 8
48412
012
0 --12
912
9N
orm
al
<80
<80
<12
0<
120
Prop
er B
P
Dia
stol
ic B
PD
iast
olic
BP
mm
Hg
mm
Hg
Syst
olic
BP
Syst
olic
BP
mm
Hg
mm
Hg
Cat
egor
ies
Cat
egor
ies
CV
D R
isk
CV
D R
isk
HTN
prev
alenc
e ~ 50
milli
on pe
ople
in the
Unit
ed S
tates
.
The B
P re
lation
ship
to ris
k of C
VD is
conti
nuou
s, co
nsist
ent,
and i
ndep
ende
nt of
other
risk f
actor
s.
Each
incre
ment
of 20
/10 m
mHg d
ouble
s the
risk o
f CVD
ac
ross
the e
ntire
BP
rang
e star
ting f
rom
115/7
5 mmH
g.
Preh
yper
tensio
nsign
als th
e nee
d for
incre
ased
educ
ation
to
redu
ce B
P in
orde
r to p
reve
nt hy
perte
nsion
.
Ben
efi
t o
f BP c
on
tro
lBen
efi
t o
f BP c
on
tro
l
Ave
rage
Per
cen
t R
edu
ctio
n
Stro
ke in
cide
nce
35–4
0%
Myo
card
ial i
nfar
ctio
n 20
–25%
H
eart
fai
lure
50%
FA
QFA
Q
Doe
s **
* af
fect
BP
?D
oes
***
affe
ct B
P ?
––M
enop
ause
:
5 m
mH
g sy
stol
eM
enop
ause
:
5 m
mH
g sy
stol
e––
Smok
ing:
tem
pora
rySm
okin
g: t
empo
rary
––St
ress
:St
ress
:––
Obe
sity
:O
besi
ty:
––Co
ffee
& s
odas
: te
mpo
rary
Coff
ee &
sod
as:
tem
pora
ry––
Pota
ssiu
m:
prot
ectio
nPo
tass
ium
: pr
otec
tion
––O
ral p
ills
Ora
l pill
s––
HRT,
sed
ativ
es, t
ranq
uiliz
ers
HRT,
sed
ativ
es, t
ranq
uiliz
ers
91
BP M
easu
rem
en
t T
ech
niq
ues
BP M
easu
rem
en
t T
ech
niq
ues
Prov
ides
info
rmat
ion
on r
espo
nse
to
Prov
ides
info
rmat
ion
on r
espo
nse
to
ther
apy.
M
ay h
elp
impr
ove
ther
apy.
M
ay h
elp
impr
ove
adhe
renc
e to
the
rapy
and
eva
luat
e ad
here
nce
to t
hera
py a
nd e
valu
ate
““ whi
tew
hite
-- coa
tco
at”” H
TN.
HTN
.
Self
Self --
mea
sure
men
tm
easu
rem
ent
Indi
cate
d fo
r ev
alua
tion
of
Indi
cate
d fo
r ev
alua
tion
of ““ w
hite
whi
te--
coat
coat
”” HTN
. Abs
ence
of
10H
TN. A
bsen
ce o
f 10
–– 20%
BP
20%
BP
decr
ease
dur
ing
slee
p m
ay in
dica
te
decr
ease
dur
ing
slee
p m
ay in
dica
te
incr
ease
d CV
D r
isk.
in
crea
sed
CVD
ris
k.
Ambu
lato
ry B
P Am
bula
tory
BP
mon
itorin
gm
onito
ring
Two
read
ings
, 5 m
inut
es a
part
, Tw
o re
adin
gs, 5
min
utes
apa
rt,
sitt
ing
in c
hair.
Co
nfirm
ele
vate
d si
ttin
g in
cha
ir. Co
nfirm
ele
vate
d re
adin
g in
re
adin
g in
con
tral
ater
alco
ntra
late
ral a
rm.
arm
.
InIn-- o
ffic
eof
fice
Bri
ef D
escr
ipti
onB
rief
Des
crip
tion
Met
hod
Met
hod
Off
ice B
P M
easu
rem
en
tO
ffic
e B
P M
easu
rem
en
t
Use a
uscu
ltator
ymeth
od w
ith a
prop
erly
calib
rated
and
valid
ated i
nstru
ment.
Patie
nt sh
ould
be se
ated q
uietly
for 5
minu
tes in
a ch
air
(not
on an
exam
table
), fee
t on t
he flo
or, a
nd ar
m su
ppor
ted at
he
art le
vel.
Appr
opria
te-siz
ed cu
ff sho
uld be
used
to en
sure
accu
racy
.
At le
ast tw
o mea
sure
ments
shou
ld be
mad
e.
Clini
cians
shou
ld pr
ovide
to pa
tients
, ver
bally
and i
n writi
ng,
spec
ific B
P nu
mber
s and
BP
goals
.
Am
bu
lato
ry B
P M
on
ito
rin
gA
mb
ula
tory
BP M
on
ito
rin
g
ABPM
is w
arra
nted f
or ev
aluati
on of
“whit
e-co
at”HT
N in
the
abse
nce o
f targ
et or
gan i
njury.
Ambu
lator
y BP
value
s are
usua
lly lo
wer t
han c
linic
read
ings.
Awak
e, ind
ividu
als w
ith hy
perte
nsion
have
an av
erag
e BP
of >1
35/85
mmH
g and
durin
g slee
p >12
0/75 m
mHg.
BP dr
ops b
y 10 t
o 20%
durin
g the
nigh
t; if n
ot, si
gnals
po
ssibl
e inc
reas
ed ris
k for
card
iovas
cular
even
ts.
Self
Self
-- Measu
rem
en
t o
f BP
Measu
rem
en
t o
f BP
Prov
ides i
nform
ation
on:
1.Re
spon
se to
antih
yper
tensiv
e the
rapy
2.Im
prov
ing ad
here
nce w
ith th
erap
y 3.
Evalu
ating
whit
e-co
at HT
N
Home
mea
sure
ment
of >1
35/85
mmH
g is g
ener
ally
cons
idere
d to b
e hyp
erten
sive.
Home
mea
sure
ment
devic
es sh
ould
be ch
ecke
d reg
ularly
.
92
Ko
rotk
off
Ko
rotk
off
So
un
ds
So
un
ds
•• Cav
itat
ion
Cav
itat
ion
theo
ryth
eory
•• Vas
cula
r w
all Theo
ryVas
cula
r w
all Theo
ry•• T
urb
ule
nce
theo
ryTurb
ule
nce
theo
ry
His
tory
His
tory
1733
; Rev
eren
d St
ephe
n 17
33;
Rev
eren
d St
ephe
n H
ales
Hal
es18
47;
Carl
Ludw
ig18
47;
Carl
Ludw
ig’’ ss
kym
ogra
phky
mog
raph
1896
;18
96;
Scip
ione
Scip
ione
Riv
aRiv
a --Ro
cci
Rocc
i19
05;
Nik
olai
19
05;
Nik
olai
Kor
otko
ffKo
rotk
off
Mer
cury
sph
ygm
oman
omet
erM
ercu
ry s
phyg
mom
anom
eter
––Pr
os:
Gol
d st
anda
rd, e
asy
to u
nder
stan
d an
d us
ePr
os:
Gol
d st
anda
rd, e
asy
to u
nder
stan
d an
d us
e––
Cons
: M
ercu
ry, m
aint
enan
ce, o
pera
tion
bias
Cons
: M
ercu
ry, m
aint
enan
ce, o
pera
tion
bias
Aner
oid
sphy
gmom
anom
eter
Aner
oid
sphy
gmom
anom
eter
––Pr
os:
Mer
cury
fre
e, w
ell
Pros
: M
ercu
ry f
ree,
wel
l --un
ders
tood
by
user
s, e
asy
calib
ratio
nun
ders
tood
by
user
s, e
asy
calib
ratio
n––
Cons
: Pr
one
to o
bser
ver
bias
, wea
r &
tea
rCo
ns:
Pron
e to
obs
erve
r bi
as, w
ear
& t
ear
Sem
iSe
mi --
auto
mat
ed d
evic
esau
tom
ated
dev
ices
Auto
mat
ed d
evic
esAu
tom
ated
dev
ices
––Pr
os:
Mer
cury
fre
e, n
o ob
serv
er b
ias,
eas
y to
use
Pros
: M
ercu
ry f
ree,
no
obse
rver
bia
s, e
asy
to u
se––
Cons
: H
ome
orig
inat
ed, n
ot f
or a
ll pa
tient
s, d
iffic
ult
to c
alib
rCo
ns:
Hom
e or
igin
ated
, not
for
all
patie
nts,
diff
icul
t to
cal
ibr a
te,
ate,
hygi
ene
issu
ehy
gien
e is
sue
Pro
s &
co
ns
of
curr
en
t d
evic
es
Pro
s &
co
ns
of
curr
en
t d
evic
es
Pro
ble
ms
wit
h m
erc
ury
Pro
ble
ms
wit
h m
erc
ury
sp
hyg
mo
man
om
ete
rsp
hyg
mo
man
om
ete
r
Mer
cury
vap
or is
poi
sono
us.
Mer
cury
vap
or is
poi
sono
us.
Blac
k di
scol
orat
ion
with
tim
e.Bl
ack
disc
olor
atio
n w
ith t
ime.
Mer
cury
col
umn
kept
ris
ing
Mer
cury
col
umn
kept
ris
ing
afte
r in
flatio
n st
oppe
d.af
ter
infla
tion
stop
ped.
Cuff
doe
s no
t ris
e w
ith
Cuff
doe
s no
t ris
e w
ith
infla
tion.
infla
tion.
Obs
erve
r bi
as.
Obs
erve
r bi
as.
93
JNC
7JN
C 7
Pat
ien
ts s
hou
ld b
e se
ated
in a
ch
air
wit
h t
hei
r ba
cks
supp
orte
d w
ith
th
eir
arm
s ba
red
and
supp
orte
d at
hea
rt le
vel.
Mea
sure
men
t sh
ould
beg
in a
fter
at
leas
t 5
m
inu
tes
of r
est.
The
appr
opri
ate
cuff
siz
e sh
ould
be
use
d.M
easu
rem
ent
shou
ld b
e ta
ken
wit
h a
mer
cury
sp
hyg
mom
anom
eter
, rec
entl
y ca
libra
ted
aner
oid
man
omet
er o
r a
valid
ated
ele
ctro
nic
dev
ice.
Bot
h s
ysto
lic a
nd
dias
tolic
mea
sure
men
ts s
hou
ld
be r
ecor
ded.
Two
or m
ore
read
ings
sep
arat
ed b
y 2
min
ute
s sh
ould
be
aver
aged
. If
firs
t tw
o re
adin
gs d
iffe
r by
mor
e th
an 5
mm
Hg,
add
itio
nal
rea
din
gs
shou
ld b
e ob
tain
ed a
nd
aver
aged
.
BP m
easu
rem
en
t in
pra
ctic
eBP m
easu
rem
en
t in
pra
ctic
e
61%
kne
w c
urre
ntly
acc
epte
d pr
actic
e fo
r id
entif
ying
61
% k
new
cur
rent
ly a
ccep
ted
prac
tice
for
iden
tifyi
ng
syst
olic
BP
syst
olic
BP
71%
kne
w c
urre
ntly
acc
epte
d pr
actic
e fo
r id
entif
ying
71
% k
new
cur
rent
ly a
ccep
ted
prac
tice
for
iden
tifyi
ng
dias
tolic
BP
dias
tolic
BP
62%
pro
perly
det
erm
ined
def
latio
n ra
te
62%
pro
perly
det
erm
ined
def
latio
n ra
te
54%
cor
rect
ly in
terp
rete
d a
desc
riptio
n of
BP
soun
ds
54%
cor
rect
ly in
terp
rete
d a
desc
riptio
n of
BP
soun
ds
cont
aini
ng a
n co
ntai
ning
an
ausc
ulta
tory
ausc
ulta
tory
gap
gap
58%
cou
ld id
entif
y fa
ulty
equ
ipm
ent
58%
cou
ld id
entif
y fa
ulty
equ
ipm
ent
57%
cou
ld a
sses
s pr
oper
cuf
f si
ze
57%
cou
ld a
sses
s pr
oper
cuf
f si
ze
29%
cor
rect
ly d
eter
min
ed in
flatio
n pr
essu
re
29%
cor
rect
ly d
eter
min
ed in
flatio
n pr
essu
re
14%
cor
rect
ly d
eter
min
ed a
rm p
ositi
on f
or s
eate
d 14
% c
orre
ctly
det
erm
ined
arm
pos
ition
for
sea
ted
mea
sure
men
t.m
easu
rem
ent.
"Nur
ses'
Kno
wle
dge
of E
rror
in B
lood
Pre
ssur
e M
easu
rem
ent
Tech
ni"N
urse
s' K
now
ledg
e of
Err
or in
Blo
od P
ress
ure
Mea
sure
men
t Te
chni
que"
que"
Inte
rnat
iona
l jou
rnal
of
Nur
sing
Pra
ctic
e, R
. Arm
stro
ng, J
une
20In
tern
atio
nal j
ourn
al o
f N
ursi
ng P
ract
ice,
R. A
rmst
rong
, Jun
e 20
02.
02.
BP m
easu
rem
en
t in
pra
ctic
eBP m
easu
rem
en
t in
pra
ctic
e180 –
170 –
160 –
150 –
140 –
130 –
120 –
110 –
100 –
90 –
80 –
0 –
174
3
166
4
158
4155
5
146
3
92
289
390
288
282
2
Sp
ecia
list
Fam
ily
Ph
ysic
ian
Researc
h
Tech
nic
ian
Bp
TR
UA
mb
ula
tory
BP
Blood Pressure (mmHg)
Mye
rs M
, Can
. J. C
ardi
olog
y; 2
002;
18
(sup
p B
): 1
13B
94
Just
ific
ati
on
fo
r o
ust
ing
merc
ury
Just
ific
ati
on
fo
r o
ust
ing
merc
ury
Mer
cury
tox
icity
Mer
cury
tox
icity
Reg
ulat
ions
reg
ardi
ng u
se in
wor
k pl
ace
Reg
ulat
ions
reg
ardi
ng u
se in
wor
k pl
ace
Atte
mpt
s to
elim
inat
e hu
man
err
ors
Atte
mpt
s to
elim
inat
e hu
man
err
ors
Majo
r co
nce
rns
Majo
r co
nce
rns
Valid
atio
nVa
lidat
ion
––Ch
ildre
nCh
ildre
n––
Seni
le c
itize
nSe
nile
citi
zen
––Pr
egna
ncy
Preg
nanc
y––
VHD
VHD
––Ar
rhyt
hmia
s;Ar
rhyt
hmia
s;AfAf
Calib
ratio
nCa
libra
tion
––D
iffic
ultie
sD
iffic
ultie
s
Exp
ect
ati
on
sExp
ect
ati
on
s
Accu
rate
& in
telli
gent
Accu
rate
& in
telli
gent
Econ
omic
Econ
omic
Smal
l & p
orta
ble
Smal
l & p
orta
ble
Easy
to
use
Easy
to
use
One
fits
all
One
fits
all
Dur
able
Dur
able
Easy
to
calib
rate
Easy
to
calib
rate
Tha
nk y
ou
95
The
Acc
urac
y an
d T
race
abili
ty o
f N
onIn
vasi
ve A
utom
ated
Sphy
gmom
anom
eter
s
Ch
en-C
hu
an
Hu
ng
Mea
sure
men
t S
tan
dard
& L
eagal
Met
rolo
gy
Div
isio
nC
ente
r fo
r M
easu
rem
ent
Sta
ndard
s /
ITR
IB
ldg. 08, 321 K
uan
gF
u R
d, S
ec. 2
Hsi
nch
u, T
aiw
an
300, R
.O.C
.T
el:
88
6-3
-57
43
78
8F
ax
: 8
86
-3-5
72
49
52
E-m
ail
: c-
chu
ng
@it
ri.o
rg.t
w
Pri
ncip
les
The
con
vent
iona
l m
etho
dis
to
mon
itor
the
sou
nds
gene
rate
d by
the
flo
w o
f bl
ood
duri
ng t
he in
flat
ion
and
defl
atio
n of
a b
lood
pre
ssur
e cu
ff u
sing
a
stet
hosc
ope
Whe
n th
e pr
essu
re o
f th
e cu
ff is
gre
ater
tha
n in
trav
ascu
lar
pres
sure
, the
blo
od in
the
upp
er a
rm
fails
to
pass
thr
ough
the
cuf
f an
d no
sou
nd c
an b
e he
ard
from
the
ste
thos
cope
whe
n th
e pr
essu
re o
f th
e cu
ff g
radu
ally
rel
ease
s,
bloo
d ca
n pa
ss t
hrou
gh t
he c
uff
Pri
ncip
les
(con
tinu
e)
The
pre
ssur
e va
lue
corr
espo
ndin
g to
the
mer
cury
co
lum
n is
the
sys
tolic
pre
ssur
e, w
hen
the
firs
t so
und
appe
ars
The
sou
nd b
ecom
es lo
uder
and
the
n de
ep a
nd lo
w.
The
pre
ssur
e va
lue
whe
n th
e so
und
fina
lly
disa
ppea
rs is
the
dia
stol
ic p
ress
ure
The
non
inva
sive
aut
omat
edsp
hygm
oman
omet
erap
plie
d on
the
upp
er a
rm w
as f
irst
mar
ket
laun
ched
in 1
975.
Pri
ncip
les
(con
tinu
e)
The
aut
omat
ed o
scill
omet
ric
sphy
gmom
anom
eter
was
firs
t la
unch
ed in
abo
ut 1
985.
Whe
n th
e cu
ff b
ecom
es in
flat
ed a
nd d
efla
ted,
pre
ssur
e os
cilla
tion
s co
ntin
uous
ly o
ccur
due
to
the
fluc
tuat
ions
of
arte
rial
blo
od p
ress
ure.
The
osc
illat
ions
incr
ease
to
a m
axim
um a
mpl
itud
e an
d th
en d
ecre
ase
unti
l the
cuf
f fu
lly d
efla
tes.
The
se o
scill
atio
n si
gnal
s an
d cu
ff p
ress
ure
are
stor
ed;
the
syst
olic
pre
ssur
e an
d th
e di
asto
lic p
ress
ure
are
deri
ved
on t
he b
asis
of
them
thr
ough
a p
ropr
ieta
ry
algo
rith
m d
evel
oped
by
the
man
ufac
ture
r of
the
dev
ice.
96
The
Wei
ghts
and
Mea
sure
s A
ct
Leg
al m
easu
ring
inst
rum
ent:
a m
easu
ring
in
stru
men
t th
at is
des
igna
ted
by t
he c
ompe
tent
au
thor
ity
for
use
in t
rade
, cer
tifi
cati
on, o
ffic
ial
insp
ecti
on a
nd t
esti
ng o
r en
viro
nmen
tal p
rote
ctio
n ac
tivi
ties
, or
is r
elat
ed t
o pu
blic
saf
ety
and/
or
med
ical
and
hea
lth
care
aff
airs
(m
echa
nica
l sp
hygm
oman
omet
er a
nd a
utom
ated
sphy
gmom
anom
eter
)
The
Wei
ghts
and
Mea
sure
s A
ct(c
onti
nue)
M
atte
rs r
elat
ed t
o m
etro
logi
cal a
ffai
rs s
hall
be h
andl
ed
by a
ded
icat
ed a
utho
rity
(Min
istr
y of
Eco
nom
ic A
ffai
rs )
as
des
igna
ted
by t
he c
ompe
tent
aut
hori
ty (
med
ical
dev
ices
sh
all f
irst
be
insp
ecte
d an
d re
gist
ered
by
the
Dep
artm
ent
of H
ealt
h an
d th
en b
e su
bjec
ted
to t
ype
appr
oval
and
ve
rifi
cati
on)
In o
rder
to
ensu
re f
air
trad
e an
d to
mai
ntai
n pr
oper
pu
blic
saf
ety
and
heal
th a
nd e
nvir
onm
enta
l pro
tect
ion,
th
e co
mpe
tent
aut
hori
ty m
ay d
esig
nate
mea
suri
ng
inst
rum
ents
tha
t ar
e pr
ovid
ed f
or u
se …
(the
use
of
mer
cury
sha
ll be
ban
ned
for
mea
sure
men
t in
the
fut
ure)
Ove
rall
Syst
em A
ccur
acy
of N
IBP
Max
imum
per
mis
sibl
e er
rors
of
the
over
all s
yste
m a
s m
easu
red
by c
linic
al t
ests
1.R
equi
rem
ent
of O
IML
R16
-2(T
aiw
an w
ill f
ollo
w t
his
stan
dard
)•
max
imum
mea
n er
ror
of m
easu
rem
ent:
0.7
kPa
5 m
mH
g
•m
axim
um e
xper
imen
tal s
tand
ard
devi
atio
n:1.
1 kP
a8
mm
Hg
2.R
equi
rem
ents
of
EN
106
0 an
d A
AM
I SP
10•
max
imum
mea
n er
ror
of m
easu
rem
ent:
0.7
kPa
5 m
mH
g
•m
axim
um e
xper
imen
tal s
tand
ard
devi
atio
n:1.
1 kP
a8
mm
Hg
Max
imum
perm
issi
ble
erro
rs o
f th
e cu
ff p
ress
ure
indi
cati
on
NIB
Pac
cura
cy d
eter
min
ed b
y co
mpa
riso
n w
ith
stat
ic
pres
sure
sta
ndar
d1.
Req
uire
men
t of
OIM
L R
16-2
(15
C-2
5C
)•
0.4
kPa
(3
mm
Hg)
in c
ase
of v
erif
ying
the
firs
t tim
e
•0.
5 kP
a (
4 m
mH
g) f
or s
phyg
mom
anom
eter
s in
use
2.R
equi
rem
ent
of E
N 1
060
(15
C-2
5C
)•
0.4
kPa
(3
mm
Hg)
3.R
equi
rem
ent
of A
AM
I SP
10•
3 m
mH
g (1
8C
-33
C)
•3
mm
Hg
or 2
w
hich
ever
is g
reat
er (
10C
-17
C a
nd 3
4C
-40
C )
97
Ver
ific
atio
n an
d In
spec
tion
of
NIB
P in
Tai
wan
(The
Wei
ghts
and
Mea
sure
s A
ct)
Ver
ific
atio
n: e
xam
inat
ion
and
test
ing
of a
lega
l m
easu
ring
inst
rum
ent
to e
nsur
e th
at it
com
plie
s w
ith
rela
ted
met
rolo
gica
l req
uire
men
ts(f
ull v
erif
icat
ion
for
new
pro
duct
s an
d re
-ver
ific
atio
n)
Insp
ecti
on:
exam
inat
ion
and
test
ing
of a
ver
ifie
d le
gal
mea
suri
ng in
stru
men
t in
use
to
ensu
re t
hat
it
cont
inue
s to
com
ply
wit
h m
etro
logi
cal r
equi
rem
ents
(irr
egul
arly
, app
roxi
mat
ely
once
a y
ear )
Ver
ific
atio
n an
d In
spec
tion
of
NIB
P in
Tai
wan
(con
tinu
e)
Tec
hnic
al S
peci
fica
tion
for
Ver
ific
atio
n an
d In
spec
tion
of
Non
Inva
sive
Aut
omat
edSp
hygm
oman
omet
ers
(ann
ounc
ed o
n D
ec.2
005,
will
be
carr
ied
out
on D
ec.2
009)
•T
he m
axim
um p
erm
issi
ble
erro
r of
ver
ific
atio
nis
3 m
mH
g0.
4kP
a•
The
max
imum
per
mis
sibl
e er
ror
of in
spec
tion
is
4 m
mH
g0.
5kP
a•
The
per
iod
of v
alid
ity
of v
erif
icat
ion
is 2
yea
rs
Typ
e A
ppro
valo
f N
IBP
in T
aiw
an
Tec
hnic
al S
peci
fica
tion
for
Typ
e A
ppro
valo
f N
onIn
vasi
ve A
utom
ated
Sphy
gmom
anom
eter
s(D
raft
)
•R
efer
to
OIM
L R
16-2
Non
-Inv
asiv
e A
utom
ated
Sphy
gmom
anom
eter
s(
2002
)
•T
he W
eigh
ts a
nd M
easu
res
Act
: T
he d
edic
ated
w
eigh
ts a
nd m
easu
res
auth
orit
y m
ay a
ppro
ve a
nd
desi
gnat
e la
bora
tori
es t
o co
nduc
t te
sts
of t
he
mea
suri
ng in
stru
men
ts r
equi
ring
typ
e ap
prov
al(e
xecu
te b
y ve
rifi
ed la
bora
tory
thr
ough
BSM
I co
mm
itte
e)
The
mea
sure
men
t st
anda
rd o
f N
IBP
in
ITR
I
Est
ablis
h pr
imar
y m
ercu
ry m
anom
eter
and
P
isto
n ga
uge
Col
lect
Val
idat
ed D
atab
ase
from
Clin
ical
tri
al
Est
ablis
h St
anda
rd b
lood
pre
ssur
e si
mul
atio
n sy
stem
to
repl
ay r
eal h
uman
bio
-sig
nal
reco
rded
ear
lier
in t
he c
linic
98
Las
er I
nter
fero
met
er M
ercu
ry
Man
omet
er Pre
ssur
e R
ange
1 ~
120
kPa
Exp
ande
d U
ncer
tain
ty0.
5~
1 P
a
Gas
Pis
ton
Gau
ge
Pre
ssur
e R
ange
17~1
72kP
a
Exp
ande
dU
ncer
tain
ty3.
0 x
10-5
Qua
rtz
Bou
rdon
Tub
e
Pre
ssur
e R
ange
0~41
4kP
a Exp
ande
d U
ncer
tain
ty0.
02 k
Pa
Valid
ated
Dat
abas
e fro
m C
linica
l tria
lSe
lect
85
subj
ects
at
leas
t th
ree
mea
sure
men
ts
shal
l be
carr
ied
out
wit
h re
cord
ing
unit
bot
h in
up
per
arm
and
wri
st a
ccor
ding
to
OIM
L R
16-
2 re
com
men
ded
prot
ocol
s fo
r th
e cl
inic
al
inve
stig
atio
ns a
re g
iven
in:
The
Bri
tish
Hyp
erte
nsio
n So
ciet
y pr
otoc
ol f
or t
he
eval
uati
on o
f bl
ood
mea
suri
ng d
evic
es.
DIN
581
30:
1995
,(E
N10
60)-
was
sub
stit
uted
by
e
AA
MI/
AN
SI S
P10
, Am
eric
an N
atio
nal S
tand
ard
for
elec
tron
ic o
r au
tom
ated
sph
ygm
oman
omet
ers
99
Meas
urin
g pr
oced
ure
85 s
ubje
cts-
255
pair
ed
dete
rmin
atio
ns
Rec
ordi
ng U
nit a
t upp
er a
rm
Rec
ordi
ng U
nit a
t wris
t
Reco
rdin
g Un
it
A R
ecor
ding
Uni
t w
ill b
e us
ed
for
the
reco
rdin
g of
dif
fere
nt
bloo
d pr
essu
re s
igna
ls w
hich
will
be
arc
hive
d fo
r cu
ff p
ress
ure
and
koro
tkof
fso
und
use
as in
put
to c
onst
ruct
a s
imul
ator
and
to
repl
ay t
he s
igna
ls. B
lood
pr
essu
re m
easu
rem
ents
can
be
done
aut
omat
ical
ly a
t th
e w
rist
an
d up
per
arm
.
Reco
rdin
g Un
it(co
ntin
ue)
Rec
ordi
ng o
f cu
ff p
ress
ure,
kor
otko
ffso
und
and
EC
G is
opt
iona
l, to
be
adju
sted
by
the
user
. Dat
a w
ill b
e st
ored
on
hard
dis
k di
rect
ly.
Blo
od p
ress
ure
mea
sure
men
t ta
ken
by t
wo
inde
pend
ent
obse
rver
s by
usi
ng a
dua
l-he
aded
ste
thos
cope
wit
h a
thin
rou
nd
mic
roph
one.
The
sex
, age
s, h
eigh
t, w
eigh
t, a
rtif
act,
re
fere
nce
syst
olic
and
dia
stol
ic p
ress
ure
for
infl
ate
and
defl
ate
limit
s w
ill b
e on
the
scr
een
duri
ng t
he m
easu
rem
ent.
Stan
dard
blo
od p
ress
ure s
imul
atio
n sy
stem
To
gene
rate
the
rea
l hum
an
osci
llom
atic
puls
es r
ecor
ded
earl
ier
in t
he c
linic
.
Con
trol
the
mem
bran
e-le
ver
to b
e ab
le t
o re
plic
ate
the
reco
rded
hum
an s
igna
ls
as r
eal a
s po
ssib
le
100
Stan
dard
blo
od p
ress
ure s
imul
atio
n sy
stem
(con
tinue
)C
alib
rati
on s
oftw
are
is n
eces
sary
for
cal
ibra
tion
of
pres
sure
tra
nsdu
cer,
leve
l pos
itio
n an
d di
ffer
ent
volu
mes
of
pne
umat
ic s
yste
m o
f th
e te
sted
dev
ice.
Dat
a pr
oces
sing
to
prep
are
the
data
for
the
sim
ulat
ion
incl
udin
g cu
ff p
ress
ure,
pul
se r
ate
and
defl
atio
n ra
te.
It is
nec
essa
ry t
o sp
lit t
he r
ecor
ded
cuff
pre
ssur
e os
cilla
tion
cur
ve in
to s
egm
ents
con
sist
ing
of a
sin
gle
pres
sure
pul
se. T
his
is d
one
auto
mat
ical
ly, b
ut it
can
be
mod
ifie
d by
han
d.
A d
ata
reco
rd c
onsi
sts
of a
t le
ast
4 fi
les,
the
se a
re s
tori
ng
the
sign
als
of c
uff
pres
sure
, Kor
otko
ffso
und,
el
ectr
ocar
diog
ram
and
pat
ient
dat
a.
Val
idat
ed D
atab
ase
from
Clin
ical
tri
al
Qua
lity
assu
ranc
e &
V
erif
ied
by
man
ufac
ture
Ver
ifie
d by
BSM
I
GM
P &
Reg
istr
atio
n/M
arke
t A
ppro
val
Pha
rmac
euti
cal A
ffai
rs
Act
Reg
ulat
ions
Gov
erni
ngSe
lf-v
erif
icat
ion
cond
ucte
d by
Mea
suri
ng I
nstr
umen
t E
nter
pris
es
Tec
hnic
al S
peci
fica
tion
for
V
erif
icat
ion
and
Insp
ecti
onof
Non
Inva
sive
Aut
omat
edSp
hygm
oman
omet
ers
Patt
ern
Ap
pro
val
OIM
L R
16-2
Non
Inva
s. A
utom
ated
Sphy
gmom
anom
eter
s
Dyn
amic
sim
ulat
or
Man
ufac
ture
Non
Inva
s. A
utom
ated
Sphy
gmom
anom
eter
s
Hos
pita
l
Dyn
amic
Clib
rato
r
Dat
a pr
oces
sing
and
ca
libra
tion
sof
twar
eD
ynam
ic s
imul
ator
Stan
dard
blo
od p
ress
ure
sim
ulat
ion
syst
em
Lea
gal
proc
ess
Dra
win
g up
Cal
ibra
tion
The T
race
abilit
y of N
IBP
Dev
elop
sta
ndar
d bl
ood
pres
sure
sim
ulat
ion
syst
em
by t
he c
oope
rati
on w
ith
PT
B
> 2
55su
bjec
ts V
alid
ated
Dat
abas
e fr
om C
linic
al t
rial
Subs
titu
tion
of
clin
ical
tri
al b
y da
taba
se o
f va
lidat
ed
osci
llogr
ams
Val
idat
ed D
atab
ase
from
Clin
ical
tri
al
Dat
a pr
oces
sing
and
cal
ibra
tion
sof
twar
e
Dyn
amic
sim
ulat
or
Pri
mar
y S
yste
m
PT
B
Inte
rnat
iona
lco
mpa
riso
n
Calib
ratio
n se
rvice
s for
Ho
spita
ls &
Manu
fact
urer
s
Non
Inva
s. A
utom
ated
Sphy
gmom
anom
eter
s
Dyn
amic
sim
ulat
or
Man
ufac
ture
Non
Inva
s. A
utom
ated
Sphy
gmom
anom
eter
s
Hos
pita
l
Dyn
amic
Clib
rato
r
Cal
ibra
te s
imul
ator
s
Cal
ibra
te s
phyg
mom
anom
eter
s
Cal
ibra
te p
ress
ure
sens
ors
Mea
sure
the
pre
cisi
on o
f di
agno
sis
and
the
effi
cacy
of
ther
apy
101
Patte
rn ap
prov
alT
o B
e A
Con
form
ity
Ass
essm
ent
Bod
y (C
AB
) of
the
m
edic
al d
evic
es w
ith
a m
easu
ring
fun
ctio
n fo
r B
SMI/
MO
EA
& D
OH
Exe
cute
pat
tern
exa
min
atio
n of
non
-inv
asiv
e au
tom
ated
sp
hygm
oman
omet
ers
GM
P &
Reg
istr
atio
n/M
arke
t A
ppro
val
Pha
rmac
euti
cal A
ffai
rs
Act
Patt
ern
Ap
pro
val
OIM
L R
16-2
Solu
tions
for m
anuf
actu
rers
' nee
dsA
ssis
t m
anuf
actu
rers
in
esta
blis
hmen
t of
qua
lity
syst
ems
(ISO
…, E
N…
and
FD
A…
)
Be
a C
onfo
rmit
y A
sses
smen
t B
ody
(CA
B)
of M
easu
rem
ent
Ass
uran
ce
Pro
gram
(M
AP
) to
Mai
nlan
d C
hina
Est
ablis
h au
tom
atic
tes
t sy
stem
s fo
r el
ectr
. non
-inv
asiv
e sp
hygm
oman
omet
er o
n “
”M
ark
self
-dec
lara
tion
Qua
lity
assu
ranc
e &
Ver
ifie
d by
m
anuf
actu
re
Reg
ulat
ions
Gov
erni
ngSe
lf-v
erif
icat
ion
cond
ucte
d by
Mea
suri
ng I
nstr
umen
t E
nter
pris
es
Tec
hnic
al S
peci
fica
tion
for
V
erif
icat
ion
and
Insp
ecti
onof
Non
Inva
sive
Aut
omat
edSp
hygm
oman
omet
ers
Solu
tion
for v
erifi
catio
n by
BSM
ISe
tup
auto
mat
ic v
erif
icat
ion
syst
ems
for
elec
tr. n
on-
inva
sive
sph
ygm
oman
omet
er o
n “
”M
ark
Ver
ifie
d by
BSM
I
Than
k You
102
Coun
try
Repo
rtof
the
King
dom
of
Cam
bodi
a
Sem
inar
onA
utom
ated
Sph
ygm
oman
omet
ers
from
Jul
y 17
-21,
200
6In
Tai
pei,
Chin
ese
Taip
ei
byM
r. K
IM C
hand
ara
Dep
uty
Dir
ecto
r,
Dep
artm
ent
of M
etro
logy
Min
istr
y of
Ind
ustr
y, M
ines
and
Ene
rgy
1-
Bri
ef
His
tory
-199
5 E
stab
lishm
ent o
f Wei
ghts
and
Mea
sure
s U
nit u
nder
the
Tec
hnic
al D
epar
tmen
t of M
inis
try
of In
dust
ry, M
ines
and
Ene
rgy
(MIM
E).
-1
999
Upg
rade
d to
be
the
Dep
artm
ent o
f Met
rolo
gy (
DO
M),
und
erM
IME
.-2
000
Bec
ame
the
Cor
resp
ondi
ng M
embe
r of
OIM
L.-2
002
Bec
ame
the
Ful
l Mem
ber
of A
PLM
F.
2-
Str
uctu
re o
f M
etr
olo
gy
Rec
ently
, the
Met
rolo
gy o
f Cam
bodi
a is
spl
it be
twee
n th
e D
epar
tmen
t of M
etro
logy
(D
OM
) an
d In
dust
rial L
abor
ator
yC
ente
r of
Cam
bodi
a (I
LCC
).
DO
M h
as th
e re
spon
sibi
lity
for
all L
egal
Met
rolo
gy A
ctiv
ities
an
d ke
eps
the
Sec
onda
ry a
nd W
orki
ng S
tand
ards
.
ILC
C k
eeps
the
Prim
ary
Sta
ndar
d an
d al
so im
plem
ents
the
Indu
stria
l and
Sci
entif
ic M
etro
logy
req
uest
ed b
y D
OM
. Our
st
ruct
ure
is in
Ann
ex N
o 01
.
3-
Self
-In
tro
du
cti
on
.
Who
am
I?
My
nam
e is
KIM
Cha
ndar
a. Y
ou c
an c
all m
e K
IM. I
hav
e be
en w
orki
ng
in M
etro
logy
sin
ce 1
996.
Pre
sent
ly, m
y po
sitio
n is
Dep
uty
Dire
ctor
of
Dep
artm
ent o
f Met
rolo
gy (
DO
M),
in c
harg
e of
Inte
rnat
iona
l C
oope
ratio
n, M
etro
logi
cal T
echn
olog
y D
evel
opm
ent a
nd T
estin
g La
bora
torie
s. I
assi
st a
lso
my
Dire
ctor
to o
rgan
ize
the
trai
ning
of
met
rolo
gica
l sta
ff.
Now
, I d
o no
t hav
e an
y ex
perie
nce
on T
ype
App
rova
l or
Ver
ifica
tion
or
Re-
verif
icat
ion
of m
edic
al d
evic
es in
clud
ing
The
rmom
eter
or
Aut
omat
ed
Sph
ygm
oman
omet
ers.
103
4-
Sit
ua
tio
n o
f A
uto
ma
ted
Sp
hy
gm
om
an
om
ete
rs in
Ca
mb
od
ia
In C
ambo
dia,
mos
tly o
f sph
ygm
oman
omet
er u
sed
in h
ospi
tals
, clin
ics,
fa
mily
use
are
impo
rted
from
Chi
na, J
apan
, Ger
man
y, U
SA
and
oth
ers.
The
re a
re m
ore
than
20,
000
med
ical
sta
ffs in
Cam
bodi
a us
ed a
bout
5%
of M
ercu
ry S
phyg
mom
anom
eter
, 85%
of a
nero
id s
phyg
mom
anom
eter
an
d 10
% o
f Aut
omat
ed S
phyg
mom
anom
eter
whi
ch is
day
to d
ay
incr
easi
ng.
5-
Me
tro
log
ica
l c
on
tro
l o
n A
uto
ma
ted
Sp
hy
gm
om
an
om
ete
r
Mea
surin
g U
nit u
sed
for
the
Aut
omat
ed S
phyg
mom
anom
eter
is
Mill
imet
er H
g (m
mH
g).
Pre
sent
ly, m
edic
al d
evic
es in
clud
ing
The
rmom
eter
or
Sph
ygm
oman
omet
er a
re n
ot s
ubje
ct to
any
reg
ulat
ory
cont
rol a
t the
m
omen
t. P
atte
rn A
ppro
val a
nd V
erifi
catio
n su
ch in
stru
men
ts a
re n
ot
lega
lly e
nfor
ced.
DO
M is
inte
rest
ed in
this
mat
ter
beca
use
in th
e dr
afte
d la
w o
f m
etro
logy
of C
ambo
dia
ther
e is
one
art
icle
has
pre
scrib
ed o
n pu
blic
he
alth
saf
ety.
Now
Cam
bodi
a do
es n
ot h
ave
mea
sure
men
t sta
ndar
d an
d re
gula
tion
of v
erifi
catio
n or
insp
ectio
n. T
hese
dev
ices
are
ver
y im
port
ant f
or H
ealth
and
live
s; th
eref
ore
it m
ust b
e in
spec
ted
and
verif
ied.
5-
Me
tro
log
ica
l c
on
tro
l o
n A
uto
ma
ted
Sp
hy
gm
om
an
om
ete
r (c
on
’t)
We
fore
see
that
the
med
ical
dev
ices
reg
ulat
ion
com
ing
forc
e in
the
futu
re. S
o w
e ne
ed to
upg
rade
of T
echn
ical
com
pete
nce
and
capa
bilit
y.
The
ado
ptio
n of
OIM
L re
com
men
datio
n in
the
Tec
hnic
al R
egul
atio
n is
en
visa
ged.
We
hope
to le
arn
the
met
hods
equ
ipm
ent r
equi
rem
ents
for
a go
od v
erifi
catio
n. T
here
fore
the
part
icip
atio
n to
this
trai
ning
cou
rse
will
be
very
impo
rtan
t for
me
to g
et a
nd s
hare
exp
erie
nce
from
lect
urer
s an
d co
lleag
ues
part
icip
ants
of t
hese
mat
ters
.
6-
Ac
kn
ow
led
ge
me
nt
Fin
ally
on
beha
lf of
mys
elf,
I wou
ld li
ke to
exp
ress
my
sinc
ere
than
ks to
D
r. M
AT
SU
MO
TO
who
has
sup
port
ed m
e to
this
trai
ning
cou
rses
and
pa
rtic
ular
ly a
ll le
ctur
ers
and
orga
nize
rs w
ho h
ave
alw
ays
cont
acts
and
fa
cilit
ated
me
befo
re a
nd d
urin
g th
e tr
aini
ng c
ours
es.
Tha
nk y
ou fo
r yo
ur k
ind
atte
ntio
n.
104
Ann
ex 1
Org
an
iza
tio
n C
ha
rt
Min
istr
y o
f In
du
str
y,
Min
es
an
d E
ne
rgy
Und
er D
oM:
U
nder
ILC
C:
1-T
he
re a
re f
ive
off
ice
s
-Th
ere
are
tw
o L
ab
ora
tori
es
a-A
dmin
. and
Leg
isla
tion.
a-F
ood,
Mic
robi
olog
y, C
hem
ical
Lab
.b-
Con
trol
-Ver
ifica
tion.
b-S
cien
tific
, Ind
ustr
ial M
etro
logy
Lab
.c-
Tec
hnol
ogic
al D
evel
opm
ent o
f Met
rolo
gy.
d-P
rovi
ncia
l Man
agem
ent M
etro
logy
.e-
Tax
-Acc
ount
ing.
2-R
oo
m V
eri
fic
ati
on
of
Do
M,
co
ns
ists
of
a-M
ass
Sec
tion.
b-V
olum
e S
ectio
n.c-
Tem
pera
ture
Sec
tion.
d-P
ress
ure-
For
ce S
ectio
n.e-
Dim
ensi
onal
Sec
tion.
f-E
lect
ricity
Sec
tion.
3-
Fiv
e R
eg
ion
al
Ve
rifi
ca
tio
n C
en
ters
(Reg
iona
l).
4-
Tw
en
ty-f
ou
r P
rov
inc
ial
Me
tro
log
y O
ffic
es
(Loc
al).
Dire
ctio
n G
ener
al o
f Ind
ustr
y
Dep
artm
ent o
f Met
rolo
gyIn
dust
rial L
abor
ator
y C
ente
r of
Cam
bodi
aO
ther
Dep
artm
ents
105
CO
UN
TR
Y R
EP
OR
TC
OU
NT
RY
RE
PO
RT
AP
EC
/AP
LMF
Sem
inar
and
Tra
inin
g C
ours
e in
Leg
al M
etro
logy
A
PE
C/A
PLM
F S
emin
ar a
nd T
rain
ing
Cou
rse
in L
egal
Met
rolo
gy
(CT
I(C
TI --
11/2
006T
)11
/200
6T)
Sem
inar
on
Aut
omat
ed S
phyg
mom
anom
eter
sS
emin
ar o
n A
utom
ated
Sph
ygm
oman
omet
ers
ononJu
liJu
li1717
––21
, 200
6 at
the
How
ard
Inte
rnat
iona
l Hou
se
21, 2
006
at th
e H
owar
d In
tern
atio
nal H
ouse
inin
Tai
pei,C
hine
seT
aipe
i,Chi
nese
Tai
pei
Tai
pei
Pre
se
nte
d b
yP
res
en
ted
by
Nin
oN
ino
Waw
anW
awan
SE
TIA
WA
NS
ET
IAW
AN
DIR
EC
TO
RA
TE
OF
ME
TR
OLO
GY
DIR
EC
TO
RA
TE
OF
ME
TR
OLO
GY
DIR
EC
TO
RA
TE
GE
NE
RA
L O
F D
OM
ES
TIC
TR
AD
ED
IRE
CT
OR
AT
E G
EN
ER
AL
OF
DO
ME
ST
IC T
RA
DE
TH
E M
INIS
TR
Y O
F T
RA
DE
OF
TH
E R
EP
UB
LIC
OF
IN
DO
NE
SIA
TH
E M
INIS
TR
Y O
F T
RA
DE
OF
TH
E R
EP
UB
LIC
OF
IN
DO
NE
SIA
Gen
eral
Ove
rvie
w o
f Ind
ones
ia
Off
icia
l Nam
e: R
epub
lic o
f In
done
sia
Popu
latio
n:
238.
452.
952
Capi
tal C
ity:
Jaka
rta
Lang
uage
s: B
ahas
aIn
done
sia
(off
icia
l), E
nglis
h, D
utch
, loc
al d
iale
cts,
the
m
ost
wid
ely
spok
en o
f w
hich
is J
avan
ese
Nat
iona
l Ant
hem
: In
done
sia
Raya
Off
icia
l Cur
renc
y: R
upia
hLo
catio
n: S
outh
east
ern
Asia
, bet
wee
n Au
stra
lia &
Asi
a Co
ntin
ents
, ar
chip
elag
o be
twee
n th
e In
dian
Oce
an a
nd t
he P
acifi
c O
cean
, M
ain
Isla
nds:
Sum
atra
, Jav
a, K
alim
anta
n, S
ulaw
esi&
Iria
nPr
ovin
ces:
Ind
ones
ia h
as 3
3 pr
ovin
ces
Clim
ate:
tro
pica
l; ho
t, h
umid
; m
ore
mod
erat
e in
hig
hlan
ds, s
easo
ns;
dry
and
wet
Surf
ace
area
: 1
.900
.000
km
2
Latit
ude/
Long
itude
6º
18S,
106
º83
E
Ove
rvie
w o
f Dire
ctor
ate
of M
etro
logy
and
loca
l Met
rolo
gy o
ffice
s
Dire
ctor
ate
of M
etro
logy
is u
nder
the
Min
istr
y of
Tr
ade,
D
irect
orat
e G
ener
al o
f D
omes
tic T
rade
Dire
ctor
ate
of M
etro
logy
to
cons
ist
of:
1.Su
b D
irect
orat
e of
Met
rolo
gica
l Fac
ility
and
Hum
an
Reso
urce
2.Su
b D
irect
orat
e of
Met
rolo
gica
l Coo
pera
tion
3.Su
b D
irect
orat
e of
Mea
sure
men
t St
anda
rd a
nd
Met
rolo
gica
l Lab
orat
ory
4.Su
b D
irect
orat
e of
Met
rolo
gica
l Tec
hniq
ue5.
Sub
Dire
ctor
ate
of S
uper
visi
on a
nd M
etro
logi
cal
Info
rmat
ion
106
The
mai
n t
asks
of
the
Dir
ecto
rate
of
Met
rolo
gy a
re:
The
mai
n t
asks
of
the
Dir
ecto
rate
of
Met
rolo
gy a
re:
to c
onse
rve
refe
renc
e st
anda
rds,
to c
onse
rve
refe
renc
e st
anda
rds,
to d
raw
up
tech
nica
l reg
ulat
ions
for
mea
surin
g in
stru
men
ts,
to d
raw
up
tech
nica
l reg
ulat
ions
for
mea
surin
g in
stru
men
ts,
to r
ecru
it, e
duca
te a
nd t
rain
met
rolo
gy o
ffic
ials
(m
etro
logy
to
rec
ruit,
edu
cate
and
tra
in m
etro
logy
off
icia
ls (
met
rolo
gy
engi
neer
s an
d le
gal m
etro
logy
tec
hnic
ians
),en
gine
ers
and
lega
l met
rolo
gy t
echn
icia
ns),
to c
arry
out
typ
e ev
alua
tion
and
to is
sue
type
app
rova
ls f
or
to c
arry
out
typ
e ev
alua
tion
and
to is
sue
type
app
rova
ls f
or
mea
surin
g in
stru
men
ts t
o be
impo
rted
or
prod
uced
,m
easu
ring
inst
rum
ents
to
be im
port
ed o
r pr
oduc
ed,
supe
rvis
e le
gal m
easu
ring
inst
rum
ent;
and
pre
supe
rvis
e le
gal m
easu
ring
inst
rum
ent;
and
pre
-- pac
kage
d go
ods
and
pack
aged
goo
ds a
nd
givi
ng m
etro
logy
info
rmat
ion;
givi
ng m
etro
logy
info
rmat
ion;
to im
plem
ent
rela
tions
with
the
OIM
Lto
impl
emen
t re
latio
ns w
ith t
he O
IML
Dire
ctor
ate
of M
etro
logy
is t
he n
atio
nal i
ssui
ng a
utho
rity
for
Type
App
rova
lCe
rtifi
cate
for
impo
rted
mea
surin
g in
stru
men
ts a
nd d
omes
tic p
rodu
ct o
fm
easu
ring
inst
rum
ents
The
Org
aniz
atio
nal S
truc
ture
of
Dir
ecto
rate
of
Met
rolo
gy
Func
tiona
l Off
icia
l Gro
up/
Ver
ific
atio
n O
ffic
er G
roup
NIN
O W
.SE
TIA
WA
N
Sect
ion
of
Hum
an R
esou
rce
Sect
ion
of
Acc
redi
tatio
n an
d
Soft
war
e SU
ply
Sub
Dir
ecto
rate
of
Met
rolo
gica
l Fac
ility
and
Hum
an
Res
ourc
e
Sect
ion
of
Mea
sure
men
t Sta
ndar
d
for
Flow
, Len
gth
&
Vol
ume
Sect
ion
of
Mea
sure
men
t Sta
ndar
d
for
Mas
s, E
lect
rici
ty
Forc
e &
Tem
pera
ture
Sub
Dir
ecto
rate
of
Mea
sure
men
t
Stan
dard
and
Met
rolo
gica
l Lab
orat
ory
Sect
ion
of M
easu
rem
ent
for
Flow
, Len
gth
and
Vol
ume
Sect
ion
of M
easu
rem
ent
for
Mas
s, E
lect
rici
ty,
Forc
e an
d T
empe
ratu
re
Sub
Dir
ecto
rate
of
Met
rolo
gica
l
Tec
hniq
ue
Sect
ion
of I
nfor
mat
ion
and
Act
iviti
onof
Soc
iety
Sect
ion
of S
uper
visi
on
for
Mea
suri
ng
Inst
rum
ent &
Pre
pack
aged
Com
mod
ity
Sub
Dir
ecto
rate
of
Supe
rvis
ion
and
Met
rolo
gica
l
Info
rmat
ion
Sect
ion
of I
nter
natio
nal
Met
rolo
gica
l
Coo
pera
tion
Sect
ion
of N
atio
nal
Met
rolo
gica
l
Coo
pera
tion
Sub
Dir
ecto
rate
of
Met
rolo
gica
l
Coo
pera
tion
Dir
ecto
rate
of
Met
rolo
gy
Labo
rato
ry o
f the
Dire
ctor
ate
of M
etro
logy
Labo
rato
ry o
f the
Dire
ctor
ate
of M
etro
logy
Labo
rato
ry o
f M
ass
Labo
rato
ry o
f Fo
rce
Labo
rato
ry o
f Pr
essu
reLa
bora
tory
of
Leng
thLa
bora
tory
of
Volu
me
Labo
rato
ry o
f Te
mpe
ratu
reLa
bora
tory
of
Elec
tric
Labo
rato
ry o
f H
ealth
& E
nviro
nmen
t
Loca
l Met
rolo
gy O
ffice
s:Lo
cal M
etro
logy
Offi
ces:
Ther
e ar
e fif
tyTh
ere
are
fifty
-- fiv
e lo
cal m
etro
logy
off
ices
fiv
e lo
cal m
etro
logy
off
ices
th
roug
hout
Ind
ones
ia.
thro
ugho
ut I
ndon
esia
.Th
eir
mai
n ta
sks
are:
Thei
r m
ain
task
s ar
e:to
man
age
phys
ical
ref
eren
ce s
tand
ards
,to
man
age
phys
ical
ref
eren
ce s
tand
ards
,to
ver
ify m
easu
ring
inst
rum
ents
and
con
trol
to
ver
ify m
easu
ring
inst
rum
ents
and
con
trol
re
liabi
lity
of m
ass,
vol
ume
or t
otal
con
tent
of
relia
bilit
y of
mas
s, v
olum
e or
tot
al c
onte
nt o
f pr
epr
e --pa
cked
goo
ds,
pack
ed g
oods
,to
inve
stig
ate
cont
rave
ntio
ns o
f th
e Le
gal
to in
vest
igat
e co
ntra
vent
ions
of
the
Lega
l M
etro
logy
Law
.M
etro
logy
Law
.
107
ME
AS
UR
EM
EN
T L
AW
& R
EG
UL
AT
ION
S
Dire
ctor
ate
of M
etro
logy
:D
irect
orat
e of
Met
rolo
gy:
51 p
erso
ns (
mal
e: 4
6 pe
rson
s, fe
mal
e: 7
per
son)
51 p
erso
ns (
mal
e: 4
6 pe
rson
s, fe
mal
e: 7
per
son)
Loca
l Met
rolo
gy O
ffice
:Lo
cal M
etro
logy
Offi
ce:
900
pers
ons
(spr
ead
out i
n 55
offi
ces)
900
pers
ons
(spr
ead
out i
n 55
offi
ces)
’
Cal
ibra
tion
of A
utom
ated
Sph
ygm
oman
omet
ers
Aut
omat
ed S
phyg
mom
anom
eter
sar
e ca
rrie
d ou
t by
OIM
L R
ecom
men
datio
n (R
16-2
)
108
Cal
ibra
tion
met
hods
an c
alib
ratio
n of
inst
rum
enta
l err
or s
hall
be
an c
alib
ratio
n of
inst
rum
enta
l err
or s
hall
be
carr
ied
out b
y :
carr
ied
out b
y :
OIM
L M
ET
HO
DS
TO
CO
MP
AR
E
OIM
L M
ET
HO
DS
TO
CO
MP
AR
E
ST
AN
DA
RD
AN
D U
ND
ER
TE
ST
ST
AN
DA
RD
AN
D U
ND
ER
TE
ST
Ref
eren
ce:
Ref
eren
ce:
Teri
makasih
ata
sP
erh
ati
an
nya
tha
nk
yo
u v
ery
mu
ch
for
yo
ur
att
en
tio
n
Teri
makasih
ata
sP
erh
ati
an
nya
tha
nk
yo
u v
ery
mu
ch
for
yo
ur
att
en
tio
nC
hin
ese
Tai
pei
,Ju
ly21
,200
6C
hin
ese
Tai
pei
,Ju
ly21
,200
6
109
Curr
ent
Situ
ation
In M
alay
sia
Rega
rding
The
Cont
rol Of
Inst
rumen
ts F
or M
edical U
se
Pre
se
nte
d b
y:
Ms. H
air
an
i N
ord
in
Metr
olo
gis
t, M
ech
an
ical M
etr
olo
gy S
ecti
on
NM
L-S
IRIM
, M
AL
AY
SIA
Ju
ly, 2006
1. G
en
era
l
Weig
hts
an
d M
easu
res A
ct
1972
Main
leg
isla
tio
n r
eg
ula
tin
g w
eig
hts
, m
easu
res
an
d m
easu
rin
g in
str
um
en
ts in
Mala
ysia
. T
he
Act
is e
nfo
rced
by t
he M
inis
try o
f D
om
esti
c
Tra
de a
nd
Co
nsu
mer
Aff
air
s.
Th
e m
ain
pro
vis
ion
s o
f th
e A
ct
are
bri
efl
y d
escri
bed
as b
elo
w:
1. T
he A
ct
pre
scri
bes t
he u
se o
f th
e In
tern
ati
on
al S
yste
m o
f
Un
its (
S.I.)
as t
he o
nly
leg
al u
nit
s t
o b
e u
sed
in
Mala
ysia
.
2. It
pro
vid
es f
or
the a
pp
oin
tmen
t o
f a C
usto
dia
n o
f W
eig
hts
an
d M
easu
res t
o r
ealise, esta
blish
an
d m
ain
tain
nati
on
al
measu
rem
en
t sta
nd
ard
s t
o p
rovid
e t
raceab
ilit
y o
f m
sm
tto
veri
ficati
on
sta
nd
ard
s u
sed
fo
r le
gal en
forc
em
en
t.
Th
e N
ML
-SIR
IM c
arr
ies o
ut
the d
uti
es a
nd
resp
on
sib
ilit
ies o
f th
e C
usto
dia
n.
3. A
syste
m o
f m
etr
olo
gic
al co
ntr
ol o
f m
easu
rin
g in
str
um
en
ts
for
trad
e u
se is r
eg
ula
ted
un
der
this
Act.
It
is e
ffecte
d
thro
ug
h t
he r
eq
uir
em
en
t fo
r p
att
ern
ap
pro
val o
f n
ew
instr
um
en
ts b
y t
he C
usto
dia
n a
nd
th
e v
eri
ficati
on
an
d
re-v
eri
ficati
on
of
the m
easu
rin
g in
str
um
en
ts b
y t
he
Insp
ecto
rs o
f W
eig
hts
an
d M
easu
res.
2. C
on
tro
l o
f M
easu
rin
g In
str
um
en
ts f
or
Med
ical U
se
Measu
rin
g in
str
um
en
ts f
or
med
ical u
se s
uch
as c
lin
ical
therm
om
ete
rs, sp
hyg
mo
man
om
ete
rs, h
aem
acyto
mete
r
dilu
tio
n p
ipett
es, etc
are
no
t su
bje
ct
to a
ny r
eg
ula
tory
co
ntr
ol
at
the m
om
en
t. P
att
ern
ap
pro
val an
d v
eri
ficati
on
of
su
ch
instr
um
en
ts a
re a
s s
uch
no
t le
gally e
nfo
rced
.
Th
e M
inis
try o
f H
ealt
h h
ow
ever
is c
urr
en
tly d
raft
ing
an
Act
on
Med
ical D
evic
es w
hic
h w
ill em
ph
asiz
e o
n t
he n
eed
fo
r all
med
ical d
evic
es p
rocu
red
to
meet
wit
h c
ert
ain
sta
nd
ard
s.
Co
mm
on
Typ
e o
f S
ph
yg
mo
man
om
ete
r u
sed
by m
ed
ical
pra
cti
tio
ners
in
Mala
ysia
:
(i)
Merc
ury
Man
om
ete
r
(ii)
Ela
sti
c S
en
sin
g E
lem
en
t (e
.g D
ial T
yp
e)
110
3.
Cu
rren
t D
irecti
on
Jo
ined
th
e In
tern
ati
on
al O
rgan
izati
on
of
Leg
al M
etr
olo
gy
(OIM
L)
as a
co
rresp
on
din
g m
em
ber
in 1
989 a
nd
has s
ince
gra
du
ally a
do
pte
d a
nu
mb
er
of
OIM
L in
tern
ati
on
al
reco
mm
en
dati
on
s a
nd
gu
idelin
es f
or
its p
att
ern
evalu
ati
on
an
d v
eri
ficati
on
pro
ced
ure
s.
A m
em
ber
of
the A
sia
Pacif
ic L
eg
al M
etr
olo
gy F
oru
m a
nd
has p
art
icip
ate
d in
a n
um
ber
of
train
ing
co
urs
es, w
ork
sh
op
s,
meeti
ng
s s
ince its
in
cep
tio
n in
No
vem
ber
1994.
Will co
nti
nu
e t
o m
ain
tain
lia
iso
n a
nd
co
op
era
tio
n w
ith
reg
ion
al an
d in
tern
ati
on
al o
rgan
izati
on
s t
o k
eep
ab
reast
wit
h
the d
evelo
pm
en
ts in
leg
al m
etr
olo
gy in
its
eff
ort
to
ach
ieve
harm
on
izati
on
, m
utu
al re
co
gn
itio
n a
nd
up
gra
din
g o
f
tech
nic
al co
mp
ete
nce a
nd
cap
ab
ilit
y.
It is f
ore
seen
th
at
wit
h t
he M
ed
ical D
evic
es A
ct
co
min
g
into
fo
rce in
th
e n
ear
futu
re s
om
e r
eg
ula
tory
co
ntr
ol o
n
sp
hyg
mo
man
om
ete
rs in
clu
din
g o
ther
med
ical in
str
um
en
ts
will b
e e
nfo
rced
. T
he a
do
pti
on
of
OIM
L r
eco
mm
en
dati
on
s
in t
he t
ech
nic
al re
gu
lati
on
s is e
nvis
ag
ed
.
4.
Fu
ture
Dir
ecti
on
111
NATIONAL METROLOGY LABORATORY, SIRIM BERHAD, MALAYSIA
Current Situation In Malaysia Regarding The Control Of Instruments For Medical Use.
1. General
The Weights and Measures Act 1972 is the main legislation regulating weights, measures and measuring instruments in Malaysia. The Act is enforced by the Ministry of Domestic Trade and Consumer Affairs. The main provisions of the Act are briefly described as below:
(i) The Act prescribes the use of the International System of Units (S.I.) as the only legal units to be used in Malaysia.
(ii) It provides for the appointment of a Custodian of Weights and Measures to realise, establish and maintain national measurement standards to provide traceability of measurements to verification standards used for legal enforcement. The National Metrology Laboratory in SIRIM Berhad carries out the duties and responsibilities of the Custodian.
(iii) A system of metrological control of measuring instruments for trade use is regulated under this Act. The control is effected through the requirement for pattern approval of new instruments by the Custodian and the verification and reverification of the measuring instruments by the Inspectors of Weights and Measures.
While the scope of the Weights and Measures Act covers all fields of measurements its existing provisions are very much focussed on the regulation of fair trade practices and control of measuring instruments used in the direct retail trade sector. As a result the effective control of measuring instruments used in other fields of trade measurements is delegated to other regulatory authorities.
2. Control of Measuring Instruments for Medical Use
Measuring instruments for medical use such as clinical thermometers, sphygmomanometers, haemacytometer dilution pipettes, etc are not subject to any regulatory control at the moment. Pattern approval and verification of such instruments are as such not legally enforced.
The Ministry of Health however is currently drafting an Act on Medical Devices which will emphasize on the need for all medical devices procured to meet with certain standards.
As regards the sphygmomanometers the most common type used by medical practitioners in Malaysia is the mercury manometer type followed by
112
manometers with an elastic sensing element. Automated sphygmomanometers are used to a lesser extent but are gradually increasing in home use.
3. Future Direction
Malaysia joined the International Organization of Legal Metrology (OIML) as a corresponding member in 1989 and has since gradually adopted a number of OIML international recommendations and guidelines for its pattern evaluation and verification procedures.
Malaysia is a member of the Asia Pacific Legal Metrology Forum and has participated in a number of training courses, workshops, meetings since its inception in November 1994.
Malaysia will continue to maintain liaison and cooperation with regional and international organizations to keep abreast with the developments in legal metrology in its effort to achieve harmonization, mutual recognition and upgrading of technical competence and capability.
It is foreseen that with the Medical Devices Act coming into force in the near future some regulatory control on sphygmomanometers including other medical instruments will be enforced. The adoption of OIML recommendations in the technical regulations is envisaged.
113
SEM
INA
R O
N A
UTO
MA
TED
SE
MIN
AR
ON
AU
TOM
ATE
D
SPH
YG
MO
MA
NO
MET
ERS
SPH
YG
MO
MA
NO
MET
ERS
July
18
–2
2, 2
00
6H
owar
d In
tern
atio
nal
Hou
se, T
aipe
i, C
hin
ese
Taip
ei
MO
NG
OL
IAN
AG
EN
CY
FO
R
ST
AN
DA
RD
IZA
TIO
N A
ND
ME
TR
OL
OG
Y
Das
hren
chin
Das
hren
chin
Bay
asga
lan
Bay
asga
lan
Ver
ific
atio
n O
ffic
er
Ver
ific
atio
n L
abor
ator
y of
Hea
t an
d P
ress
ure
Mea
suri
ng I
nstr
umen
ts
E-m
ail:
mas
m@
mon
gol.n
et, T
el:
+976
-51-
2639
71, F
ax +
976-
11-4
5803
2
MA
P O
F M
ON
GO
LIA
Capi
tal:
Capi
tal:
Ula
anba
atar
Ula
anba
atar
Tota
l pop
ulat
ion:
To
tal p
opul
atio
n: 3
.0 m
illio
n (J
uly
2006
3.
0 m
illio
n (J
uly
2006
estest ))
Area
:Ar
ea:
1.56
5 m
illio
n sq
km
.1.
565
mill
ion
sq k
m.
Loca
tion:
Nor
ther
n As
ia, b
etw
een
Chin
a an
d Rus
sia
Loca
tion:
Nor
ther
n As
ia, b
etw
een
Chin
a an
d Rus
sia
MO
NG
OL
IAN
AG
EN
CY
FO
R S
TA
ND
AR
DIZ
AT
ION
AN
D
MO
NG
OL
IAN
AG
EN
CY
FO
R S
TA
ND
AR
DIZ
AT
ION
AN
D
ME
TR
OL
OG
YM
ET
RO
LO
GY
MO
NG
OL
IAN
AG
EN
CY
FO
R S
TA
ND
AR
DIZ
AT
ION
AN
D
ME
TR
OL
OG
Y
The
mai
n f
un
ctio
ns
are:
Stan
dard
izat
ion
Cert
ifica
tion
Esta
blis
hmen
t of
nat
iona
l mea
sure
men
t st
anda
rds
Lega
l met
rolo
gyAc
cred
itatio
nSt
ate
supe
rvis
ion
of s
tand
ardi
zatio
n, q
ualit
y an
d m
etro
logy
Trai
ning
and
con
sulti
ngIn
tern
atio
nal c
oope
ratio
n
114
Mon
golia
n Ag
ency
for
Sta
ndar
diza
tion
and
Met
rolo
gy
is a
Gov
ernm
ent
regu
lato
ry a
genc
y re
spon
sibl
e fo
r co
ordi
natin
g an
d m
anag
ing
the
stan
dard
izat
ion,
m
etro
logy
, tes
ting
and
qual
ity s
ecto
r th
ruog
huot
the
coun
try.
MAS
M r
epor
ts t
o th
e D
eput
y Pr
ime
Min
iste
r of
Mon
golia
Mis
sion
To c
ontr
ibut
e to
the
soc
ial a
nd e
cono
mic
de
velo
pmen
t of
Mon
golia
in c
onju
nctio
n w
ith t
he
deve
lopm
ent
stra
tegi
c te
nden
cy b
y ap
plyi
ng
stan
dard
izat
ion,
qua
lity
and
met
rolo
gy.
MA
SM
MA
SM
ch
art
CH
AIR
MA
NN
AT
ION
AL
CO
UN
CIL
VIC
E C
HA
IRM
AN
Cer
tifi
cati
on
Off
ice
Stan
dard
izat
ion
and
Com
form
ity
Ass
essm
ent
Pol
icy
Dep
artm
ent
Met
rolo
gyD
epar
tmen
tA
ccre
dita
tion
D
epar
tmen
tM
anag
emen
t&
Fin
ance
D
epar
tmen
t
•Se
cret
aria
t of
stan
dard
izat
ion
tech
nica
l co
mm
ittee
s•
Stan
dard
s in
form
atio
n ce
nter
W
TO
/TB
T
Enq
uiry
poi
nt
•Sta
ndar
dla
bora
tori
es -
11•V
erif
icat
ion
labo
rato
ries
-4
•Dis
pute
settl
emen
t co
mm
issi
on•T
echn
ical
com
mitt
ee•E
xper
tsco
mm
ittee
•A
dmin
istr
atio
n•
Inte
rnat
iona
l co
oper
atio
n•
Coo
rdin
atio
n of
loca
l ce
nter
s •
Fina
nce
& P
lann
ing
•Gen
eral
Aff
airs
team
Met
rolo
gy
Dep
art
men
t
Mai
n a
ctiv
itie
s:D
evel
opm
ent
of n
atio
nal s
tand
ards
sys
tem
Mai
nten
ance
and
impr
ovem
ent
of a
ccur
acy
of
mea
sure
men
t st
anda
rds
Trac
eabi
lity
of m
easu
rem
ent
stan
dard
sD
evel
opm
ent
and
regi
stra
tion
of C
ertif
ied
Refe
renc
e M
ater
ials
Calib
ratio
n of
mea
sure
men
t st
anda
rds
and
mea
surin
g in
stru
men
ts w
ith h
igh
accu
racy
Prof
icie
ncy
test
ing
sche
me
Patt
ern
appr
oval
of
mea
surin
g in
stru
men
tsLi
cens
ing
for
man
ufac
ture
, rep
air,
inst
alla
tion
and
sale
of
mea
surin
g in
stru
men
ts
Met
rolo
gy D
epar
tmen
tM
etro
logy
Dep
artm
ent
Stan
dard
labo
rato
ries
Ver
ific
atio
n la
bora
tori
es
Mas
s
Den
sity
Len
gth
Vol
ume
Pres
sure
Elic
tric
ity
Tem
pera
ture
Phys
ico-
Che
mis
try
Tim
e an
d Fr
eque
ncy
Cer
tifie
d re
fere
nce
mat
eria
ls
Ele
ctri
city
mea
suri
ng
inst
rum
ents
Hea
t and
pre
ssur
e m
easu
ring
inst
rum
ents
Mec
hani
cal m
easu
ring
in
stru
men
ts
Rec
eptio
n of
mea
suri
ng
inst
rum
ents
115
Mai
n ac
tiviti
es:
Verif
icat
ion
of m
anda
tory
inst
rum
ents
as
requ
ired
by la
wPa
tter
n ap
prov
al o
f m
easu
ring
inst
rum
ents
Li
cens
es f
or m
anuf
actu
re, r
epai
r, s
ervi
ce
and
sale
of
mea
surin
g in
stru
men
ts
Trai
ning
LE
GA
L M
ET
RO
LO
GY
Ver
ific
ati
on
laboro
rato
ryof
hea
t an
d
pre
ssu
re m
easu
rin
g i
nst
rum
ents
The
heat
and
pre
ssur
e m
easu
rem
ent
labo
rato
ry is
one
of
first
la
bora
tory
of
MAS
M a
nd b
uild
up
in 1
963.
The
heat
and
pre
ssur
e m
easu
rem
ent
labo
rato
ry a
ims
to e
ngag
e fu
nctio
ns o
f go
vern
men
t Su
perv
isio
n an
d co
ntro
l ove
r th
e he
at a
nd
pres
sure
mea
sure
men
ts.
Toda
y in
the
hea
t an
d pr
essu
re m
easu
rem
ent
fie
ld 4
6 th
ousa
nd
mea
surin
g eq
uipm
ent’s
of
16 t
ypes
are
use
d in
Mon
golia
.
The
mai
n fu
nctio
ns:
Patt
ern
appr
oval
of
heat
and
pre
ssur
e m
easu
ring
inst
rum
ents
Verif
icat
ion
of m
anda
tory
hea
t an
d pr
essu
re
mea
surin
g in
stru
men
ts a
s re
quire
d by
law
In t
he v
erifi
catio
n la
bora
tory
, usi
ng b
elow
wor
king
st
anda
rd:
Tem
pera
ture
: 0.
05 0
C in
ran
ge o
f (-
45 t
o 30
0) 0
CPr
essu
re:
0.05
% in
ran
ge o
f (-
1to
600
)ba
rH
eat:
0.
2 %
in r
ange
of
(0 t
o 80
) m
3 /h
Also
the
our
labo
rato
ry v
erifi
ed h
eatm
eter
and
stea
mm
eter
of a
ll ty
pe us
e in
the
Mon
golia
Hea
t an
d P
ress
ure
mea
suri
ng i
nst
rum
ents
Sph
ygm
om
an
om
eter
s
Toda
y m
ercu
ry, a
nero
id a
nd a
utom
ated
sp
hygm
oman
omet
ers
are
wid
ely
used
in m
edic
al f
ield
s of
M
ongo
lia.
Abou
t 25
00 s
phyg
mom
anom
eter
s u
sed
in t
he m
edic
al
inst
itute
s.
Alm
ost
of t
hem
ar
e m
ade
Russ
ia, C
hina
, Ger
man
y, J
apan
.
116
The
labo
rato
ry h
as e
quip
ped
by
prec
isio
n d
ead
wei
ght
test
er t
ype
MP-
04 w
ithac
cura
cy 0
,05
mad
e in
Ru
ssia
.
Also
ha
s eq
uipp
ed b
ypr
ecis
ion
dea
d w
eigh
tin
telli
gent
pre
ssur
e ca
libra
tor
type
HX6
00B
with
ac
cura
cy
0,05
mad
e in
Chi
na.
Acco
rdin
g to
re
com
men
datio
nsO
IML
R 1
6 -1
by
the
dire
ct
met
hod
verif
ied
sphy
gmom
anom
eter
sm
echa
nica
l typ
e.
Au
tom
ate
d S
ph
ygm
om
an
om
eter
s
Pres
ent
time
our
labo
rato
ry c
ould
n't
verif
y an
y au
tom
ated
sph
ygm
oman
omet
er.
Reas
on o
f th
em
-ha
ven’
t m
easu
rem
ent
stan
dard
-ha
ven’
t st
anda
rd m
etho
d of
the
ve
rific
atio
n
Acco
rdin
g to
the
Mon
golia
n la
w o
n “T
race
abili
ty o
f M
easu
rem
ent
Uni
form
ity”,
man
dato
ry m
easu
ring
inst
rum
ents
ar
e in
clud
ing
sphy
gmom
anom
eter
s ve
rifie
d by
the
ver
ifica
tion
body
.
Even
so,
in t
he o
ur la
bora
tory
hav
e no
t te
st e
quip
men
t or
inst
rum
ents
, the
aut
omat
ed s
phyg
mom
anom
eter
s ca
n no
t be
ver
ified
rec
ently
.
Futu
re, t
he b
ody
is p
lann
ing
to p
repa
re n
atio
nal
stan
dard
on
the
test
or
calib
ratio
n of
the
ric
alau
tom
ated
sph
ygm
oman
omet
ers,
and
to
purc
hase
ne
cess
ary
test
equ
ipm
ent
or in
stru
men
ts.
Cu
rren
t posi
tion
in
th
e M
on
goli
aS
um
mary
Effe
ctiv
enes
s of
par
ticip
atin
g in
thi
s se
min
ar a
re t
akin
g un
ders
tand
ing
abou
t ge
nera
l kno
wle
dge
of a
utom
ated
sp
hygm
oman
omet
ers,
req
uire
men
ts o
n th
em a
nd o
ther
inte
rnat
iona
l tes
t m
etho
ds
or s
tand
ard
of v
erifi
catio
n, a
nd s
tudy
ing
stan
dard
tes
t or
cal
ibra
tion
equi
pmen
t an
d m
easu
ring
inst
rum
ents
.
117
Than
k y
ou fo
ryo
ur a
tten
tion
118
PA
PU
A N
EW
GU
INE
A N
AT
ION
AL
IN
ST
ITU
TE
OF
ST
AN
DA
RD
S &
IN
DU
ST
RIA
L T
EC
HN
OL
OG
Y
The N
IS
IT
Str
uctu
re
Dir
ecto
r
Gen
era
l
Measu
rem
e
nt
Sta
nd
ard
s
Lab
ora
tory
Tech
nic
al
Sta
nd
ard
s
CE
RT
IFIC
AT
ION
PN
GL
AS
SO
3
OIC
CO
RP
OR
AT
E
SE
RV
ICE
KB
O
Metr
olo
gi
st
SO
2 / E
1
TS
O
E2 / S
O1
PN
GQ
MS
CS
E1
Info
/Sale
s
Off
icer
Acco
un
ta
nt
KB
O
NISIT in B
rief
•A
n A
ct
Passed B
y P
arliam
ent
in 1
99
3 k
now
n a
s t
he
NIS
IT
Act
199
3
•T
o e
xcel as A
uth
orit
y in P
NG
on s
tandardiz
ati
on, be
offic
ially r
ecogniz
ed a
s t
echnic
ally c
om
pete
nt
to
assis
t m
anufactu
rin
g a
nd s
ervic
e industr
ies inclu
din
g
infrastr
uctu
re s
ervic
es in a
ssurin
g s
usta
inabilit
y o
f
quality
products
, servic
es o
r p
rocess t
o s
ati
sfy
custo
mers n
eeds t
hru t
he u
se o
f s
tandards
Measurem
ent
Sta
ndards
Laborato
ry
•(M
SL)
–departm
ent
in N
IS
IT
–E
sta
blishm
ent
and M
ain
tenance o
f t
he
Nati
onal M
easurem
ent
Syste
m
–D
issem
inati
on o
f t
he N
ati
onal
Measurem
ent
Sta
ndards, and
–Provid
ing T
echnic
al S
upport
& T
rain
ing
119
Healt
h D
epartm
ent
Imm
ed
iate
Reg
ula
tors
of
All M
ed
ical
Instr
um
en
ts in
Pap
ua N
ew
Gu
inea
•P
rote
ctio
n B
ody
Reg
ula
te u
nd
er:
Hea
lth A
ct
Un
der
the N
ISIT
Act
1993:
NIS
IT is
man
date
d to
car
ry o
ut a
nd im
plem
ent l
egal
m
etro
logy
in th
e co
untr
y
Current
Practi
ce
•T
he H
ealt
h D
epartm
ent
Auto
mate
d S
phygm
om
anom
ete
rs a
re
wid
ely
used in a
lmost
all m
ajo
r p
ublic
hospit
als
all o
ver t
he c
ountr
y.
•Non-Invasive B
lood P
ressure M
onitor
(NIBP) ……………………………18%
•Aneroid /
Mercury………82%
Auto
mate
d
Sphygm
om
anom
ete
rs
•U
nit
of m
easure
> m
mH
g
•M
anagem
ent
of S
phygm
om
anom
ete
rs inclu
din
g o
ther
medic
al devic
es a
re g
uid
ed b
y A
S/N
ZS
35
51:
20
04
:T
echnic
al m
anagem
ent
program
s f
or m
edic
al devic
es
•T
ype a
pprovals
are n
ot
requir
ed a
t present
sin
ce P
NG
does
not
manufactu
re s
uch e
quip
ments
and o
ther d
evic
es in
general
•V
erif
icati
on o
f s
phygm
om
anom
ete
rs is h
ighly
necessary a
nd
is u
sually p
erform
ed b
y H
ealt
h D
epartm
ent
(NIS
IT
, IC
CC
)
•A
t present
OIM
L R
ecom
mendati
on (
R 1
6-2
) is
not
imple
mente
d a
s it
is n
ot
cle
arly
understo
od. T
o d
ate
there
are n
o o
ther r
egula
tions o
n s
phygm
om
anom
ete
rs o
ther t
han
the O
IM
L R
ecom
mendati
ons
CONSTRAINTS:
•N
ot
enough f
undin
g f
or v
erif
icati
on w
ork
for m
edic
al equip
ment
by t
he G
overnm
ent
•N
o p
roperly
train
ed e
xperts
to c
arry o
ut
verif
icati
on o
n m
edic
al in
str
um
ents
•Lack o
f a
wareness in t
he a
rea o
f L
egal
Metr
olo
gy
120
Way F
orw
ard
•N
IS
IT
hopes t
o g
ain
from
this
train
ing:
–U
pdate
on v
erif
icati
on p
rocedures o
f A
uto
mate
d
Sphygm
om
anom
ete
rs
–T
hrough t
he N
IS
IT
Act
199
3, w
ork w
ith D
epartm
ent
of
Healt
h t
o b
uild u
p a
workin
g s
yste
m t
o c
heck o
n
Auto
mate
d S
phygm
om
anom
ete
rs a
s w
ell a
s o
ther
Medic
al E
quip
ment
–M
ake a
wareness t
o t
he H
ealt
h S
ecto
r o
f P
NG
on L
egal
Metr
olo
gy a
nd its
im
porta
nce in t
he H
ealt
h I
ndustr
y
END!
Thank y
ou v
ery
much f
or
your
kind a
ttention!
121
SE
MIN
AR
ON
AU
TO
MA
TE
D
SP
HY
GM
OM
AN
OM
ET
ER
S
CH
INE
SE
TA
IPE
IJu
ly, 2
006
LEO
NA
RD
O D
E L
A C
RU
Z G
AR
CIA
PR
ES
SU
RE
LA
BO
RA
TO
RY
NA
TIO
NA
L M
ET
RO
LOG
Y S
ER
VIC
E
(SN
M -
IND
EC
OP
I) -
PE
RU
LOC
AT
ION PE
RU
IS
A L
AT
IN
AM
ER
ICA
NC
OU
NT
RY
.
IT I
S L
OC
AT
ED
IN
T
HE
CE
NT
RA
L
AN
DO
CC
IDE
NT
AL
PAR
T O
F SU
D
AM
ER
ICA
INF
OR
MA
TIO
N•
Cou
ntry
(lo
ngfo
rm)
Rep
ublic
of
Peru
•C
apita
lL
ima
•T
otal
Are
a1
285
220,
00sq
uare
kilo
met
ers
•Po
pula
tion
27 4
83 8
64 (
July
2001
est
.)
•L
angu
ages
Span
ish
(off
icia
l), Q
uech
ua (
offi
cial
),A
ymar
a
•R
elig
ions
Rom
an C
atho
lic90
%
•G
over
nmen
t Typ
eC
onst
itutio
nal R
epub
lic
•C
urre
ncy
1 N
uevo
Sol
(S/
.) =
3,2
8D
olla
r(U
S$)
•In
dust
ry m
inin
g of
met
als,
petr
oleu
m,f
ishi
ng, t
extil
es,c
loth
ing,
food
pr
oces
sing
,cem
ent,
auto
asse
mbl
y,st
eel,
ship
build
ing,
met
alfa
bric
atio
n
•A
gric
ultu
reco
ffee
,cot
ton,
suga
rcan
e, r
ice,
whe
at,p
otat
oes,
plan
tain
s, c
oca;
poul
try,
beef
,dai
ry p
rodu
cts,
woo
l;fi
sh
•Pe
ruha
sth
e bi
gges
t bio
dive
rsity
of
the
wor
ld
•N
atur
alR
esou
rces
copp
er,s
ilver
,gol
d,pe
trol
eum
,tim
ber,
fish
,iro
nor
e,co
al,p
hosp
hate
,pot
ash,
hydr
opow
er
122
NA
TIO
NA
L M
ET
RO
LOG
Y S
ER
VIC
E -
(SN
M -
IND
EC
OP
I) -
PE
RU
Ad
dre
ss
:
Ca
lle
De
la
Pro
sa
13
8
Sa
n B
orj
a,
Lim
a 4
1-
PE
RU
Te
l. (
++
51
-1)
22
4-7
80
0-
An
x1
33
1
Fa
x.(
++
51
-1)
22
4-7
80
0-
An
x1
26
4
htt
p:/
/ww
w.i
nd
ec
op
i.g
ob
.pe
INT
RO
DU
CT
ION
•W
hat
is y
ou
r p
osit
ion
an
d r
esp
on
sib
ilit
y
in y
ou
r e
co
no
my
?
Iam
head
of
Fo
rce a
nd
Pre
ssu
re
Lab
ora
tory
inN
ati
on
al M
etr
olo
gy S
erv
ice
–
IND
EC
OP
I.M
y r
esp
on
sib
ilit
y is t
o k
eep
measu
rem
en
t sta
nd
ard
s a
nd
to
tra
nsm
it
traceab
ilit
y t
o t
he in
du
str
y.A
lso
to
es
tab
lis
h s
tan
da
rds
me
tho
ds
in
co
ord
inati
on
wit
h n
orm
alizati
on
are
a o
f
IND
EC
OP
I.T
he
n,th
es
e m
eth
od
sa
reu
se
d
by
lab
ora
tori
es o
r fi
scalizati
on
off
ices.
IND
EC
OP
I
INT
RO
DU
CT
ION
•W
ill yo
ub
ere
qu
ired
to
tra
in o
thers
?
Yes, IN
DE
CO
PI u
su
ally r
ealizes c
ou
rses a
bo
ut
dif
fere
nt
typ
es o
f in
str
um
en
ts a
nd
to
fu
ture
it
mig
ht
realize c
ou
rses o
n
Sp
hy
gm
om
an
om
ete
rs.
•D
oy
ou
ha
ve
an
y e
xp
eri
en
ce
s o
n t
yp
e o
r v
eri
fic
ati
on
or
ca
lib
rati
on
of
Au
tom
ate
d S
ph
yg
mo
ma
no
me
ters
?
In t
he P
eru
veri
ficati
on
is n
ot
realized
, o
nly
calib
rati
on
(An
ero
id t
yp
re, m
erc
ury
typ
e, E
lectr
on
icty
pe)
Use
of
Au
tom
ate
d
Sp
hyg
mo
man
om
ete
rsin
my e
co
no
my
Ho
w w
ide
ly A
uto
ma
ted
Sp
hy
gm
om
an
om
ete
rs a
re u
se
d?
Th
is t
yp
e o
f in
str
um
en
tsare
used
wid
ely
inth
esecto
r
healt
h (
ho
sp
ital, u
niv
ers
ity
).
An
ero
id t
yp
re4
0 %
merc
ury
typ
e40 %
Ele
ctr
on
ic t
yp
e 2
0 %
123
Metr
olo
gic
al co
ntr
ol o
n A
uto
mate
d
Sp
hy
gm
om
an
om
ete
rs i
n y
ou
r e
co
no
my
Wh
at
are
th
e u
nit
s o
f m
easu
re u
sed
fo
r A
uto
mate
d
Sp
hy
gm
om
an
om
ete
rs?
Th
e u
nit
s o
f m
easu
re u
sed
fo
r th
is t
yp
e o
f in
str
um
en
ts a
re
mm
Hg
.
Wh
ich
org
an
izati
on
s a
re r
esp
on
sib
le f
or
the c
on
tro
l an
d
reg
ula
tio
n o
ve
r A
uto
ma
ted
Sp
hy
gm
om
an
om
ete
rs?
Dep
arm
en
to
f H
ealt
h is t
he r
esp
on
sib
le f
or
the c
on
tro
l an
d
reg
ula
tio
n.
Metr
olo
gic
al co
ntr
ol o
n A
uto
mate
d
Sp
hy
gm
om
an
om
ete
rs i
n y
ou
r e
co
no
my
Are
ty
pe
ap
pro
va
ls r
eq
uir
ed
?
Th
e t
yp
e a
pp
rovals
an
d v
eri
ficati
on
s a
re n
ot
req
uir
ed
fo
r
Au
tom
ate
d S
ph
yg
mo
ma
no
me
ters
in m
y e
co
no
my
.
Is O
IML
Reco
mm
en
dati
on
(R
16-2
) u
nd
ers
too
d a
nd
imp
lem
en
ted
?
No
, o
nly
th
e R
16
-1
Tha
nk y
ou v
ery
muc
h
Leo
nard
o D
e la
cru
z
ldel
acru
z@in
deco
pi.g
ob.p
e
124
APEC
/APL
MF
Sem
inar
and
Tra
inin
g Co
urse
in Le
gal
APEC
/APL
MF
Sem
inar
and
Tra
inin
g Co
urse
in Le
gal
Met
rolo
gy (C
TIM
etro
logy
(CTI
-- 11/
2006
T)11
/200
6T)
Sem
inar
on
Auto
mat
ed S
phyg
mom
anom
eter
sSe
min
ar o
n Au
tom
ated
Sph
ygm
oman
omet
ers
July
17Ju
ly 17
––21
July
200
621
July
200
6
Radl
eyF.
Man
alo
Scie
nce
Rese
arch
Spe
cial
ist I
Nati
onal
Met
rolo
gy La
bora
tory
Indu
stri
al T
echn
olog
y De
velo
pmen
t Ins
titu
te
Depa
rtm
ent o
f Sci
ence
and
Tec
hnol
ogy
Phili
ppin
es
Job
desc
ript
ions
Job
desc
ript
ions
Perf
orm
mea
sure
men
ts a
nd c
alib
rati
ons
Perf
orm
mea
sure
men
ts a
nd c
alib
rati
ons
incl
udin
g pr
essu
re g
auge
s an
d ca
libra
tors
, in
clud
ing
pres
sure
gau
ges
and
calib
rato
rs,
anal
og a
nd m
ercu
rial
an
alog
and
mer
curi
al
sphy
gmom
anom
eter
s, e
tc.
sphy
gmom
anom
eter
s, e
tc.
Mai
ntai
ns a
nd c
ondu
ct fu
ncti
onal
test
s on
M
aint
ains
and
con
duct
func
tion
al te
sts
on
stan
dard
s of
the
labo
rato
ry
stan
dard
s of
the
labo
rato
ry
Mai
ntai
n la
bora
tory
Mai
ntai
n la
bora
tory
’’ s g
ood
cond
itio
ns
good
con
diti
on
Trai
n Ot
hers
Trai
n Ot
hers
It is
my
duty
to p
rese
nt a
trav
el re
port
as
wel
l as
tech
nica
l pr
esen
tati
on in
our
org
aniz
atio
n to
dis
sem
inat
e th
e kn
owle
dge
gain
ed to
my
colle
ague
s af
ter t
he tr
aini
ng.
A m
ore
deta
iled
trai
ning
will
als
o be
don
e to
the
staf
f of
the
labo
rato
ry th
roug
h ac
tual
or h
ands
-on
prac
tice
Auto
mat
ed s
phyg
mom
anom
eter
s ar
e no
t yet
acc
epte
d in
th
e la
bora
tory
sin
ce th
ere
is n
o pr
oced
ure
yet b
eing
fo
llow
ed, b
ut w
ith
grea
t dem
and
on it
s ca
libra
tion
, fut
ure
deve
lopm
ent i
s ex
pect
ed
Use
of A
utom
ated
Us
e of
Aut
omat
ed
sphy
gmom
anom
eter
sphy
gmom
anom
eter
Mer
curi
al s
phyg
mom
anom
eter
40%
Anal
og s
phyg
mom
anom
eter
25%
Auto
mat
ed s
phyg
mom
anom
eter
35%
( T
hese
figu
res
are
only
est
imat
es)
125
Typi
cal U
sers
Typi
cal U
sers
Auto
mat
ed s
phyg
mom
anom
eter
s ar
e Au
tom
ated
sph
ygm
oman
omet
ers
are
mos
tly
used
in h
ouse
hold
due
to th
e ea
se
mos
tly
used
in h
ouse
hold
due
to th
e ea
se
of u
se. T
hese
sph
ygm
oman
omet
er a
re n
ot
of u
se. T
hese
sph
ygm
oman
omet
er a
re n
ot
typi
cal i
n th
e ho
spit
als
but t
hey
read
ily
typi
cal i
n th
e ho
spit
als
but t
hey
read
ily
avai
labl
e fo
r the
pub
licav
aila
ble
for t
he p
ublic
Met
rolo
gica
l Con
trol
Met
rolo
gica
l Con
trol
Auto
mat
ed S
phyg
mom
anom
eter
s us
e th
e un
it m
mHg
.
The
NMB
( BHD
P-DO
H, N
atio
nal M
etro
logy
Labo
rato
ry, I
TDI,
Bure
au o
f Pro
duct
Sta
ndar
ds) a
re fe
w o
rgan
izat
ions
re
spon
sibl
e fo
r con
trol
and
regu
lati
on o
f the
se d
evic
es
Type
app
rova
ls &
ver
ifica
tion
are
requ
ired
but
is n
ot fu
lly
impl
emen
ted.
BHD
P-DO
H, a
nd B
PS (p
rese
nt)
NML,I
TDI (
futu
re)
Yes,
OIM
L rec
omm
enda
tion
(R16
-2) i
s un
ders
tood
, but
not
ye
t im
plem
ente
d. b
ut n
ot y
et im
plem
ente
d
Ther
e is
no
regu
lati
on o
n au
tom
ated
sph
ygm
oman
omet
er
in o
ur c
ount
ry o
ther
than
OIM
L.
Mea
sure
men
t Sta
ndar
dsM
easu
rem
ent S
tand
ards
Nati
onal
Met
rolo
gy La
bora
tory
, ITD
INa
tion
al M
etro
logy
Labo
rato
ry, I
TDI
•re
spon
sibl
e fo
r est
ablis
hing
and
mai
ntai
ning
the
nati
onal
sta
ndar
ds fo
r the
SI u
nits
of q
uant
itie
s
(e
.g.
mas
s, le
ngth
, tem
pera
ture
, vol
tage
, pre
ssur
e, e
tc.)
•di
ssem
inat
ion
of s
tand
ard
valu
es to
use
rs a
t ap
prop
riat
e un
cert
aint
y le
vels
is p
erfo
rmed
thro
ugh
the
calib
rati
on a
nd m
easu
rem
ent s
ervi
ces
offe
red
•is
equ
ippe
d w
ith
high
acc
urac
y st
anda
rds
and
com
para
tors
that
are
per
iodi
cally
cal
ibra
ted
and
com
pare
d w
ith
thos
e of
oth
er n
atio
nal m
etro
logy
in
stit
utes
abr
oad
to e
nsur
e in
tern
atio
nal t
race
abili
ty o
f
its
mea
sure
men
ts d
one
for t
he c
lient
s.
Lega
l met
rolo
gy d
evel
opm
ent
Lega
l met
rolo
gy d
evel
opm
ent
Nati
onal
Met
rolo
gy A
ctNa
tion
al M
etro
logy
Act
-app
rove
d on
Feb
ruar
y 3,
200
4
-est
ablis
hmen
t of t
he N
atio
nal M
easu
rem
ent
Infr
astr
uctu
re S
yste
m (N
MIS
)
-cov
ers
unit
s of
mea
sure
men
t, m
easu
ring
in
stru
men
ts, t
heir
app
licat
ion
and
met
rolo
gica
l con
trol
s, e
stab
lishm
ent o
f a
labo
rato
ry a
ccre
dita
tion
sys
tem
, and
a s
yste
m
of a
ppro
pria
te p
enal
ties
126
Nati
onal
Met
rolo
gy A
ctNa
tion
al M
etro
logy
Act
A Na
tion
al M
etro
logy
Boa
rd b
e cr
eate
d to
be
chai
red
by th
e Se
cret
ary
of D
OST
wit
h m
embe
rs fr
om o
ther
gov
ernm
ent
enti
ties
.
Repr
esen
tati
ve fr
om th
e bu
sine
ss s
ecto
r, pr
ofes
sion
al
met
rolo
gy a
ssoc
iati
on a
nd th
e ac
adem
e sh
all a
lso
be
appo
inte
d
ITDI
is m
anda
ted
to s
erve
as
the
Boar
d's
secr
etar
iat a
nd th
e
Nati
onal
Met
rolo
gy La
bora
tory
(NM
L) a
s th
e in
stit
ute'
s la
bora
tory
arm
is m
aint
aine
d an
d sh
all c
arry
out
the
tech
nica
l, ca
libra
tion
and
labo
rato
ry fu
ncti
ons
to
effe
ctiv
ely
impl
emen
t the
pro
visi
ons
of th
e ac
t
Than
k Yo
uTh
ank
You
127
Ju
ly 2
1,
20
06
Ju
ly 2
1,
20
06
Ju
ly 2
1,
20
06
AP
EC
/AP
LM
FA
PE
C/A
PL
MF
Se
min
ar
on
Au
tom
ate
d
Se
min
ar
on
Au
tom
ate
d
Sp
hy
gm
om
an
om
ete
rsS
ph
yg
mo
ma
no
me
ters
Cu
rre
nt
Po
sit
ion
an
d S
Cu
rre
nt
Po
sit
ion
an
d S
itu
ati
on
on
it
ua
tio
n o
n
Au
tom
ate
d S
ph
yg
mo
ma
no
me
ters
Au
tom
ate
d S
ph
yg
mo
ma
no
me
ters
inin
Ch
ine
se
Ta
ipe
iC
hin
es
e T
aip
ei
Intr
oduc
tion
The
Con
stitu
tion
of th
e R
epub
lic o
f Chi
na
The
Con
stitu
tion
of th
e R
epub
lic o
f Chi
na
(Art
icle
107
) T
he C
entr
al G
over
nmen
t sha
ll (A
rtic
le 1
07)
The
Cen
tral
Gov
ernm
ent s
hall
have
the
pow
er o
f leg
isla
tion
and
adm
inis
trat
ion
have
the
pow
er o
f leg
isla
tion
and
adm
inis
trat
ion
over
wei
ghts
and
mea
sure
s m
atte
rs.
over
wei
ghts
and
mea
sure
s m
atte
rs.
The
BS
MI i
s th
e re
gula
tory
aut
horit
y fo
r le
gal
met
rolo
gy in
Chi
nese
Tai
pei.
128
Law
s on
Leg
al M
easu
ring
Ins
trum
ents
The
Wei
ghts
and
Mea
sure
s A
ctE
nfor
cem
ent R
ules
of W
eigh
ts a
nd M
easu
res
Act
The
Bus
ines
s O
pera
tion
Lice
nsin
g an
d A
dmin
istr
atio
n R
egul
atio
ns o
f Mea
surin
g In
stru
men
t Ent
erpr
ises
Reg
ulat
ions
Gov
erni
ng T
ype
App
rova
l of M
easu
ring
Inst
rum
ents
Reg
ulat
ions
Gov
erni
ng V
erifi
catio
n an
d In
spec
tion
of
Mea
surin
g In
stru
men
tsR
egul
atio
ns G
over
ning
Com
mis
sion
ed M
etro
logi
cal
Act
iviti
esR
egul
atio
ns G
over
ning
Sel
f-ve
rific
atio
n C
ondu
cted
by
Mea
surin
g In
stru
men
t Ent
erpr
ises
Acc
ordi
ng to
the
Bu
sin
es
s O
pe
rati
on
Lic
en
sin
g a
nd
Ad
min
istr
ati
on
Re
gu
lati
on
s
of
Me
as
uri
ng
Inst
rum
ent E
nter
pris
es a
ny
pers
on w
ho e
ngag
es in
ope
ratin
g th
e bu
sine
ss
ofm
an
ufa
ctu
rin
g,r
ep
air
ing
orim
po
rtin
g
Sp
hy
gm
om
an
om
ete
rssh
all m
ake
appl
icat
ion
to th
e B
SM
I, ob
tain
lice
nse
and
com
plet
ed th
e pr
oced
ures
for
busi
ness
reg
istr
atio
n in
ac
cord
ance
with
rel
evan
t law
s an
d re
gula
tions
be
fore
com
men
cing
its
busi
ness
ope
ratio
ns in
ou
r co
untr
y.
•C
ate
go
rie
s o
f L
eg
al
Me
as
uri
ng
Ins
tru
me
nts
Su
bje
ct
to V
eri
fic
ati
on
(R
egul
atio
ns G
over
ning
Ver
ifica
tion
and
Insp
ectio
n of
Mea
surin
g In
stru
men
ts)
1.T
axim
eter
s;2.
Wei
ghin
g in
stru
men
ts;
3.M
ercu
ry c
linic
al th
erm
omet
ers.
4.
Vol
umet
ers
(incl
udin
g liq
uid
dosa
ge
met
ers,
dia
phra
gm g
as m
eter
s, w
ater
met
ers,
oil
met
ers,
liqu
efie
d pe
trol
eum
ga
s flo
w m
eter
s);
5.M
ilk h
ydro
met
ers;
6.E
lect
ricity
met
ers;
7) R
adar
spe
edom
eter
s;8)
Sou
nd le
vel m
eter
s;
9)C
once
ntra
tion
met
ers
(incl
udin
g br
eath
e
alco
hol t
este
rsan
d an
alyz
ers,
ric
e m
oist
ure
m
eter
s, v
ehic
le e
xhau
sts
emis
sion
san
alyz
ers)
;10
) Ill
umin
ance
met
ers;
11
)Li
quid
col
umn
pres
sure
gau
ges
(incl
udin
g
sphy
gmom
anom
eter
s);
129
The
Sev
enth
Dep
artm
ent o
f BS
MI h
eld
the
trai
ning
T
he S
even
th D
epar
tmen
t of B
SM
I hel
d th
e tr
aini
ng
cour
ses
of A
utom
ated
Sph
ygm
oman
omet
ers,
cour
ses
of A
utom
ated
Sph
ygm
oman
omet
ers,
incl
udin
g pr
actic
e ac
cord
ing
to O
IML
16in
clud
ing
prac
tice
acco
rdin
g to
OIM
L 16
-- 2 (
editi
on
2 (e
ditio
n 20
02)
on N
ovem
ber
820
02)
on N
ovem
ber
8thth
to 9
to 9
thth, 2
005.
, 200
5.
In th
e fu
ture
, The
trai
ning
cou
rses
may
be
held
In th
e fu
ture
, The
trai
ning
cou
rses
may
be
held
ever
y ye
ar.
ever
y ye
ar.
Tra
inin
g C
ou
rses o
n A
uto
mate
d
Sp
hyg
mo
man
om
ete
rsE
xper
ienc
es o
n A
utom
ated
Sph
ygm
oman
omet
ers
Exp
erie
nces
on
Aut
omat
ed S
phyg
mom
anom
eter
s
We
only
hav
e th
e ex
peri
ence
s to
cal
ibra
te th
eW
e on
ly h
ave
the
expe
rien
ces
to c
alib
rate
the
pres
sure
tran
sduc
er o
f A
utom
ated
pr
essu
re tr
ansd
ucer
of
Aut
omat
ed
Sphy
gmom
anom
eter
s.Sp
hygm
oman
omet
ers.
The
Use
of
Aut
omat
ed S
phyg
mom
anom
eter
sT
he U
se o
f A
utom
ated
Sph
ygm
oman
omet
ers
The
am
ount
of
Sphy
gmom
anom
eter
s im
port
ed
The
am
ount
of
Sphy
gmom
anom
eter
s im
port
ed
from
oth
er c
ount
ries
is a
bout
1 m
illio
n pi
eces
per
yea
r.fr
om o
ther
cou
ntri
es is
abo
ut 1
mill
ion
piec
es p
er y
ear.
The
am
ount
of
Sphy
gmom
anom
eter
s m
anuf
actu
red
The
am
ount
of
Sphy
gmom
anom
eter
s m
anuf
actu
red
and
used
in T
aiw
an is
abo
ut 0
.5 m
illio
n pi
eces
.an
d us
ed in
Tai
wan
is a
bout
0.5
mill
ion
piec
es.
The
am
ount
of
Aut
omat
ed S
phyg
mom
anom
eter
s T
he a
mou
nt o
f A
utom
ated
Sph
ygm
oman
omet
ers
is m
ore
than
80
perc
ent o
f to
tal a
mou
nt.
is m
ore
than
80
perc
ent o
f to
tal a
mou
nt.
The
Use
r on
Aut
omat
ed S
phyg
mom
anom
eter
sT
he U
ser
on A
utom
ated
Sph
ygm
oman
omet
ers
The
typi
cal u
ser
of A
utom
ated
T
he ty
pica
l use
r of
Aut
omat
ed
Sphy
gmom
anom
eter
s is
hom
e us
ers.
Sphy
gmom
anom
eter
s is
hom
e us
ers.
The
typi
cal u
ser
is b
oth
used
in th
e ho
spita
l and
T
he ty
pica
l use
r is
bot
h us
ed in
the
hosp
ital a
nd
sold
to th
e pu
blic
.so
ld to
the
publ
ic.
130
The
Aut
hori
ty in
Met
rolo
gica
l Con
trol
The
Aut
hori
ty in
Met
rolo
gica
l Con
trol
The
aut
hori
ty o
f th
e B
SMI
is r
espo
nsib
le f
or is
suin
gT
he a
utho
rity
of
the
BSM
I is
res
pons
ible
for
issu
ing
type
app
rova
l cer
tific
ates
of
Aut
omat
ed
type
app
rova
l cer
tific
ates
of
Aut
omat
ed
Sphy
gmom
anom
eter
s fo
r th
e he
alth
y sa
fety
.Sp
hygm
oman
omet
ers
for
the
heal
thy
safe
ty.
Typ
e A
ppro
val o
n A
utom
ated
Sph
ygm
oman
omet
ers
Typ
e A
ppro
val o
n A
utom
ated
Sph
ygm
oman
omet
ers
The
type
app
rova
l on
Aut
omat
ed S
phyg
mom
anom
eter
sT
he ty
pe a
ppro
val o
n A
utom
ated
Sph
ygm
oman
omet
ers
will
be
enfo
rced
in D
ec. 2
009.
will
be
enfo
rced
in D
ec. 2
009.
The
mar
king
of
this
num
ber
on th
e ty
pe a
ppro
val w
illT
he m
arki
ng o
f th
is n
umbe
r on
the
type
app
rova
l will
be s
tuck
or
mar
ked
on th
e bo
dy o
f A
utom
ated
be s
tuck
or
mar
ked
on th
e bo
dy o
f A
utom
ated
Sphy
gmom
anom
eter
s.Sp
hygm
oman
omet
ers.
Ver
ific
atio
n on
Aut
omat
ed S
phyg
mom
anom
eter
sV
erif
icat
ion
on A
utom
ated
Sph
ygm
oman
omet
ers
Acc
ordi
ng to
the
regu
latio
n of
sel
fA
ccor
ding
to th
e re
gula
tion
of s
elf --
veri
fica
tion
veri
fica
tion
cond
ucte
d by
man
ufac
ture
, the
man
ufac
ture
will
sel
f co
nduc
ted
by m
anuf
actu
re, t
he m
anuf
actu
re w
ill s
elf
veri
fy b
efor
e se
lling
in th
e m
arke
t.ve
rify
bef
ore
selli
ng in
the
mar
ket.
Acc
ordi
ng to
the
OIM
L R
16A
ccor
ding
to th
e O
IML
R16
-- 2(e
ditio
n 20
02),
2(
editi
on 2
002)
, ““ T
echn
ical
Spe
cifi
catio
n fo
r V
erif
icat
ion
and
Insp
ectio
n T
echn
ical
Spe
cifi
catio
n fo
r V
erif
icat
ion
and
Insp
ectio
n of
Non
of N
on-- I
nvas
ive
Aut
omat
ed S
phyg
mom
anom
eter
sIn
vasi
ve A
utom
ated
Sph
ygm
oman
omet
ers ””
had
had
anno
unce
d in
Dec
. 200
5.
anno
unce
d in
Dec
. 200
5.
The
type
app
rova
l and
ver
ific
atio
n w
ill b
e en
forc
ed b
y T
he ty
pe a
ppro
val a
nd v
erif
icat
ion
will
be
enfo
rced
by
BSM
I in
Dec
. 200
9.B
SMI
in D
ec. 2
009.
Tec
hnic
al R
egul
atio
nT
echn
ical
Reg
ulat
ion
The
The
““ Tec
hnic
al S
peci
fica
tion
for
Ver
ific
atio
n an
dT
echn
ical
Spe
cifi
catio
n fo
r V
erif
icat
ion
and
Insp
ectio
n of
Non
Insp
ectio
n of
Non
-- Inv
asiv
e A
utom
ated
In
vasi
ve A
utom
ated
Sp
hygm
oman
omet
ers
Sphy
gmom
anom
eter
s““
and
and
““ Tec
hnic
al S
peci
fica
tion
for
Tec
hnic
al S
peci
fica
tion
for
Typ
e A
ppro
val o
f N
onT
ype
App
rova
l of
Non
-- Inv
asiv
e A
utom
ated
In
vasi
ve A
utom
ated
Sp
hygm
oman
omet
ers
Sphy
gmom
anom
eter
s““
are
all f
ollo
wed
by
the
OIM
Lar
e al
l fol
low
ed b
y th
e O
IML
R16
R16
-- 2 in
tern
atio
nal
2 in
tern
atio
nal r
ecom
men
datio
n.
131
Ju
ly 2
1,
20
06
Ju
ly 2
1,
20
06
Ju
ly 2
1,
20
06
AP
EC
/AP
LM
FA
PE
C/A
PL
MF
Se
min
ar
on
Au
tom
ate
d
Se
min
ar
on
Au
tom
ate
d
Sp
hy
gm
om
an
om
ete
rsS
ph
yg
mo
ma
no
me
ters
Cu
rre
nt
Po
sit
ion
an
d S
Cu
rre
nt
Po
sit
ion
an
d S
itu
ati
on
on
it
ua
tio
n o
n
Au
tom
ate
d S
ph
yg
mo
ma
no
me
ters
Au
tom
ate
d S
ph
yg
mo
ma
no
me
ters
inin
Ch
ine
se
Ta
ipe
iC
hin
es
e T
aip
ei
Intr
oduc
tion
The
Con
stitu
tion
of th
e R
epub
lic o
f Chi
na
The
Con
stitu
tion
of th
e R
epub
lic o
f Chi
na
(Art
icle
107
) T
he C
entr
al G
over
nmen
t sha
ll (A
rtic
le 1
07)
The
Cen
tral
Gov
ernm
ent s
hall
have
the
pow
er o
f leg
isla
tion
and
adm
inis
trat
ion
have
the
pow
er o
f leg
isla
tion
and
adm
inis
trat
ion
over
wei
ghts
and
mea
sure
s m
atte
rs.
over
wei
ghts
and
mea
sure
s m
atte
rs.
The
BS
MI i
s th
e re
gula
tory
aut
horit
y fo
r le
gal
met
rolo
gy in
Chi
nese
Tai
pei.
132
Law
s on
Leg
al M
easu
ring
Ins
trum
ents
The
Wei
ghts
and
Mea
sure
s A
ctE
nfor
cem
ent R
ules
of W
eigh
ts a
nd M
easu
res
Act
The
Bus
ines
s O
pera
tion
Lice
nsin
g an
d A
dmin
istr
atio
n R
egul
atio
ns o
f Mea
surin
g In
stru
men
t Ent
erpr
ises
Reg
ulat
ions
Gov
erni
ng T
ype
App
rova
l of M
easu
ring
Inst
rum
ents
Reg
ulat
ions
Gov
erni
ng V
erifi
catio
n an
d In
spec
tion
of
Mea
surin
g In
stru
men
tsR
egul
atio
ns G
over
ning
Com
mis
sion
ed M
etro
logi
cal
Act
iviti
esR
egul
atio
ns G
over
ning
Sel
f-ve
rific
atio
n C
ondu
cted
by
Mea
surin
g In
stru
men
t Ent
erpr
ises
Acc
ordi
ng to
the
Bu
sin
es
s O
pe
rati
on
Lic
en
sin
g a
nd
Ad
min
istr
ati
on
Re
gu
lati
on
s
of
Me
as
uri
ng
Inst
rum
ent E
nter
pris
es a
ny
pers
on w
ho e
ngag
es in
ope
ratin
g th
e bu
sine
ss
ofm
an
ufa
ctu
rin
g,r
ep
air
ing
orim
po
rtin
g
Sp
hy
gm
om
an
om
ete
rssh
all m
ake
appl
icat
ion
to th
e B
SM
I, ob
tain
lice
nse
and
com
plet
ed th
e pr
oced
ures
for
busi
ness
reg
istr
atio
n in
ac
cord
ance
with
rel
evan
t law
s an
d re
gula
tions
be
fore
com
men
cing
its
busi
ness
ope
ratio
ns in
ou
r co
untr
y.
•C
ate
go
rie
s o
f L
eg
al
Me
as
uri
ng
Ins
tru
me
nts
Su
bje
ct
to V
eri
fic
ati
on
(R
egul
atio
ns G
over
ning
Ver
ifica
tion
and
Insp
ectio
n of
Mea
surin
g In
stru
men
ts)
1.T
axim
eter
s;2.
Wei
ghin
g in
stru
men
ts;
3.M
ercu
ry c
linic
al th
erm
omet
ers.
4.
Vol
umet
ers
(incl
udin
g liq
uid
dosa
ge
met
ers,
dia
phra
gm g
as m
eter
s, w
ater
met
ers,
oil
met
ers,
liqu
efie
d pe
trol
eum
ga
s flo
w m
eter
s);
5.M
ilk h
ydro
met
ers;
6.E
lect
ricity
met
ers;
7) R
adar
spe
edom
eter
s;8)
Sou
nd le
vel m
eter
s;
9)C
once
ntra
tion
met
ers
(incl
udin
g br
eath
e
alco
hol t
este
rsan
d an
alyz
ers,
ric
e m
oist
ure
m
eter
s, v
ehic
le e
xhau
sts
emis
sion
san
alyz
ers)
;10
) Ill
umin
ance
met
ers;
11
)Li
quid
col
umn
pres
sure
gau
ges
(incl
udin
g
sphy
gmom
anom
eter
s);
133
The
Sev
enth
Dep
artm
ent o
f BS
MI h
eld
the
trai
ning
T
he S
even
th D
epar
tmen
t of B
SM
I hel
d th
e tr
aini
ng
cour
ses
of A
utom
ated
Sph
ygm
oman
omet
ers,
cour
ses
of A
utom
ated
Sph
ygm
oman
omet
ers,
incl
udin
g pr
actic
e ac
cord
ing
to O
IML
16in
clud
ing
prac
tice
acco
rdin
g to
OIM
L 16
-- 2 (
editi
on
2 (e
ditio
n 20
02)
on N
ovem
ber
820
02)
on N
ovem
ber
8thth
to 9
to 9
thth, 2
005.
, 200
5.
In th
e fu
ture
, The
trai
ning
cou
rses
may
be
held
In th
e fu
ture
, The
trai
ning
cou
rses
may
be
held
ever
y ye
ar.
ever
y ye
ar.
Tra
inin
g C
ou
rses o
n A
uto
mate
d
Sp
hyg
mo
man
om
ete
rsE
xper
ienc
es o
n A
utom
ated
Sph
ygm
oman
omet
ers
Exp
erie
nces
on
Aut
omat
ed S
phyg
mom
anom
eter
s
We
only
hav
e th
e ex
peri
ence
s to
cal
ibra
te th
eW
e on
ly h
ave
the
expe
rien
ces
to c
alib
rate
the
pres
sure
tran
sduc
er o
f A
utom
ated
pr
essu
re tr
ansd
ucer
of
Aut
omat
ed
Sphy
gmom
anom
eter
s.Sp
hygm
oman
omet
ers.
The
Use
of
Aut
omat
ed S
phyg
mom
anom
eter
sT
he U
se o
f A
utom
ated
Sph
ygm
oman
omet
ers
The
am
ount
of
Sphy
gmom
anom
eter
s im
port
ed
The
am
ount
of
Sphy
gmom
anom
eter
s im
port
ed
from
oth
er c
ount
ries
is a
bout
1 m
illio
n pi
eces
per
yea
r.fr
om o
ther
cou
ntri
es is
abo
ut 1
mill
ion
piec
es p
er y
ear.
The
am
ount
of
Sphy
gmom
anom
eter
s m
anuf
actu
red
The
am
ount
of
Sphy
gmom
anom
eter
s m
anuf
actu
red
and
used
in T
aiw
an is
abo
ut 0
.5 m
illio
n pi
eces
.an
d us
ed in
Tai
wan
is a
bout
0.5
mill
ion
piec
es.
The
am
ount
of
Aut
omat
ed S
phyg
mom
anom
eter
s T
he a
mou
nt o
f A
utom
ated
Sph
ygm
oman
omet
ers
is m
ore
than
80
perc
ent o
f to
tal a
mou
nt.
is m
ore
than
80
perc
ent o
f to
tal a
mou
nt.
The
Use
r on
Aut
omat
ed S
phyg
mom
anom
eter
sT
he U
ser
on A
utom
ated
Sph
ygm
oman
omet
ers
The
typi
cal u
ser
of A
utom
ated
T
he ty
pica
l use
r of
Aut
omat
ed
Sphy
gmom
anom
eter
s is
hom
e us
ers.
Sphy
gmom
anom
eter
s is
hom
e us
ers.
The
typi
cal u
ser
is b
oth
used
in th
e ho
spita
l and
T
he ty
pica
l use
r is
bot
h us
ed in
the
hosp
ital a
nd
sold
to th
e pu
blic
.so
ld to
the
publ
ic.
134
The
Aut
hori
ty in
Met
rolo
gica
l Con
trol
The
Aut
hori
ty in
Met
rolo
gica
l Con
trol
The
aut
hori
ty o
f th
e B
SMI
is r
espo
nsib
le f
or is
suin
gT
he a
utho
rity
of
the
BSM
I is
res
pons
ible
for
issu
ing
type
app
rova
l cer
tific
ates
of
Aut
omat
ed
type
app
rova
l cer
tific
ates
of
Aut
omat
ed
Sphy
gmom
anom
eter
s fo
r th
e he
alth
y sa
fety
.Sp
hygm
oman
omet
ers
for
the
heal
thy
safe
ty.
Typ
e A
ppro
val o
n A
utom
ated
Sph
ygm
oman
omet
ers
Typ
e A
ppro
val o
n A
utom
ated
Sph
ygm
oman
omet
ers
The
type
app
rova
l on
Aut
omat
ed S
phyg
mom
anom
eter
sT
he ty
pe a
ppro
val o
n A
utom
ated
Sph
ygm
oman
omet
ers
will
be
enfo
rced
in D
ec. 2
009.
will
be
enfo
rced
in D
ec. 2
009.
The
mar
king
of
this
num
ber
on th
e ty
pe a
ppro
val w
illT
he m
arki
ng o
f th
is n
umbe
r on
the
type
app
rova
l will
be s
tuck
or
mar
ked
on th
e bo
dy o
f A
utom
ated
be s
tuck
or
mar
ked
on th
e bo
dy o
f A
utom
ated
Sphy
gmom
anom
eter
s.Sp
hygm
oman
omet
ers.
Ver
ific
atio
n on
Aut
omat
ed S
phyg
mom
anom
eter
sV
erif
icat
ion
on A
utom
ated
Sph
ygm
oman
omet
ers
Acc
ordi
ng to
the
regu
latio
n of
sel
fA
ccor
ding
to th
e re
gula
tion
of s
elf --
veri
fica
tion
veri
fica
tion
cond
ucte
d by
man
ufac
ture
, the
man
ufac
ture
will
sel
f co
nduc
ted
by m
anuf
actu
re, t
he m
anuf
actu
re w
ill s
elf
veri
fy b
efor
e se
lling
in th
e m
arke
t.ve
rify
bef
ore
selli
ng in
the
mar
ket.
Acc
ordi
ng to
the
OIM
L R
16A
ccor
ding
to th
e O
IML
R16
-- 2(e
ditio
n 20
02),
2(
editi
on 2
002)
, ““ T
echn
ical
Spe
cifi
catio
n fo
r V
erif
icat
ion
and
Insp
ectio
n T
echn
ical
Spe
cifi
catio
n fo
r V
erif
icat
ion
and
Insp
ectio
n of
Non
of N
on-- I
nvas
ive
Aut
omat
ed S
phyg
mom
anom
eter
sIn
vasi
ve A
utom
ated
Sph
ygm
oman
omet
ers ””
had
had
anno
unce
d in
Dec
. 200
5.
anno
unce
d in
Dec
. 200
5.
The
type
app
rova
l and
ver
ific
atio
n w
ill b
e en
forc
ed b
y T
he ty
pe a
ppro
val a
nd v
erif
icat
ion
will
be
enfo
rced
by
BSM
I in
Dec
. 200
9.B
SMI
in D
ec. 2
009.
Tec
hnic
al R
egul
atio
nT
echn
ical
Reg
ulat
ion
The
The
““ Tec
hnic
al S
peci
fica
tion
for
Ver
ific
atio
n an
dT
echn
ical
Spe
cifi
catio
n fo
r V
erif
icat
ion
and
Insp
ectio
n of
Non
Insp
ectio
n of
Non
-- Inv
asiv
e A
utom
ated
In
vasi
ve A
utom
ated
Sp
hygm
oman
omet
ers
Sphy
gmom
anom
eter
s““
and
and
““ Tec
hnic
al S
peci
fica
tion
for
Tec
hnic
al S
peci
fica
tion
for
Typ
e A
ppro
val o
f N
onT
ype
App
rova
l of
Non
-- Inv
asiv
e A
utom
ated
In
vasi
ve A
utom
ated
Sp
hygm
oman
omet
ers
Sphy
gmom
anom
eter
s““
are
all f
ollo
wed
by
the
OIM
Lar
e al
l fol
low
ed b
y th
e O
IML
R16
R16
-- 2 in
tern
atio
nal
2 in
tern
atio
nal r
ecom
men
datio
n.
135
Th
an
k Y
ou
We
b s
ite
:
htt
p:/
/ww
w.b
sm
i.g
ov.t
w
E-m
ail
:
me
tro
log
y@
bs
mi.
go
v.t
w
136
Met
rica
l con
trol
on
Sphy
gmom
anom
eter
s in
Vie
tnam
Pre
sen
ted
by
: B
ui
Tru
ng D
un
g
DIR
EC
TO
RA
TE
FO
R S
TA
ND
AR
DS
AN
D Q
UA
LIT
Y
ST
AM
EQ
–V
IET
NA
M
My
nam
e is
Bui
Tru
ng D
ung,
an
expe
rt o
f m
etro
logy
m
anag
ing,
Met
rolo
gy D
epar
tmen
t, D
irec
tora
te f
or
Stan
dard
s an
d Q
ualit
y of
Vie
tnam
(ST
AM
EQ
)
My
mai
n jo
b is
to a
sses
s do
cum
ents
, app
rove
pa
ttern
s of
dif
fere
nt m
eans
of
mea
sure
men
t to
be
impo
rted
and
pro
duce
d in
Vie
tnam
Bri
ef in
trod
ucti
on o
f ju
ridi
cal
met
rolo
gy in
Vie
tnam
The
Sys
tem
of
Leg
al U
nits
of
mea
sure
men
t in
Vie
tnam
is
Inte
rnat
iona
l Sys
tem
Uni
ts (
SI)
The
Dir
ecto
rate
for
Sta
ndar
ds a
nd Q
ualit
y is
the
stat
e ap
prop
riat
e au
thor
ity, w
hich
bel
ongs
to th
e M
inis
try
of
Scie
nce
and
Tec
hnol
ogy,
take
s re
spon
sibi
lity
to d
o co
nsul
tant
wor
ks f
or th
e go
vern
men
t abo
ut m
easu
ring
is
sues
Bri
ef in
trod
ucti
on o
f ju
ridi
cal m
etro
logy
in
Vie
tnam
Dir
ecto
rate
for
Sta
ndar
ds a
nd Q
ualit
y (S
TA
ME
Q)
is
resp
onsi
ble
for
cont
rol a
nd in
spec
tion
of m
eans
of
mea
sure
men
t in
who
le c
ount
ry.
Bra
nche
s of
ST
AM
EQ
in p
rovi
nces
are
in c
harg
e of
co
ntro
l and
insp
ectio
n of
one
s in
thei
r lo
calit
y.
137
Org
aniz
atio
ns in
ST
AM
EQ
Bri
ef in
trod
ucti
on o
f ju
ridi
cal
met
rolo
gy in
Vie
tnam
Dir
ecto
rate
for
Sta
ndar
ds a
nd Q
ualit
y (S
TA
ME
Q)
is r
espo
nsib
le f
or c
ontr
ol a
nd
insp
ectio
n of
mea
ns o
f m
easu
rem
ent i
n w
hole
co
untr
y.B
ranc
hes
of S
TA
ME
Q in
pro
vinc
es a
re in
ch
arge
of
cont
rol a
nd in
spec
tion
of o
nes
in th
eir
loca
lity.
The
use
of
Aut
omat
ed
Sphy
gmom
anom
eter
s in
Vie
tnam
. Acc
ordi
ng to
the
stat
istic
al d
ata
in 2
004,
ther
e ar
e ap
prox
imat
ely
over
38,
000
sphy
gmom
anom
eter
s us
ed in
the
hosp
itals
in V
ietn
am, i
nclu
ding
two
grou
ps o
f bl
ood
pres
sure
equ
ipm
ent:n
on-a
utom
atic
an
d au
tom
atic
equ
ipm
ent
Non
-aut
omat
ic e
quip
men
t inc
lude
s M
ercu
ry a
nd
Ane
roid
equ
ipm
ent w
hich
acc
ount
for
ove
r 90
% o
f th
e to
tal n
umbe
r. T
he r
est i
s au
tom
atic
one
s.
138
In V
ietn
am, t
he s
phyg
mom
anom
eter
s in
the
list o
f eq
uipm
ent t
o be
ver
ifie
d
Any
org
aniz
atio
n or
indi
vidu
al b
usin
ess,
who
w
ants
to p
rodu
ce o
r im
port
sph
ygm
oman
omet
ers
into
Vie
tnam
, has
to ta
ke th
e pa
ttern
app
rova
l by
the
appr
opri
ate
auth
ority
of
Met
rica
l Man
agem
ent.
STA
ME
Q is
the
appr
opri
ate
auth
ority
take
s th
e du
ty
to o
rgan
ize
a pa
ttern
app
rovi
ng, m
easu
ring
asp
ect
cont
rolli
ng a
nd in
spec
ting
for
sphy
gmom
anom
eter
s
Leg
isla
tive
con
trol
on
Sphy
gmom
anom
eter
s
The
sph
ygm
oman
omet
ers
have
to b
e in
itial
ly o
r su
bseq
uent
ly v
erif
ied
at th
e st
ate
appr
opri
ate
auth
ority
of
ver
ific
atio
n.A
t pre
sent
, We
can
only
ver
ify
Ane
roid
and
Mer
cury
sp
hygm
oman
omet
ers
For
the
auto
mat
ed e
quip
men
t, w
e ar
e no
t abl
e to
dep
loy
veri
fica
tion
beca
use
mos
t of
the
equi
pmen
t are
bei
ng
used
at h
ouse
hold
s, s
o th
e ne
ed o
f ve
rify
ing
is n
ot
muc
h. F
urth
er m
ore,
we
don'
t hav
e m
easu
ring
sta
ndar
ds
and
tech
nica
l doc
umen
ts f
or v
erif
ying
aut
omat
ed
equi
pmen
t.
Leg
isla
tive
con
trol
on
Sphy
gmom
anom
eter
s
Exp
ecta
tion
In n
ear
futu
re, w
hen
the
quan
tity
of A
utom
ated
Sp
hygm
oman
omet
ers
is in
crea
sed
in h
ospi
tals
, clin
ics
and
hous
ehol
ds, w
e fi
nd th
e ve
rifi
catio
n fo
r th
ese
devi
ces
will
be
a ve
ry u
rgen
t tas
k an
d w
ill r
ecei
ve th
e sp
ecia
l int
eres
t by
the
Gov
ernm
ent
Res
earc
hing
on
the
appl
icat
ion
of r
ecom
men
datio
n O
IML
R16
-2 a
nd th
e re
late
d do
cum
ents
to e
dit t
he
proc
edur
e of
ver
ific
atio
n fo
r au
tom
ated
sp
hygm
oman
omet
ers
are
very
nec
essa
ryfo
r th
e m
easu
ring
man
agem
ent b
odie
s in
Vie
tnam
On
beha
lf S
TA
ME
Q, V
ietn
am I
wou
ld li
ke
to e
xpre
ss m
y gr
atitu
de to
APL
MF
secr
etar
iat
and
APE
C s
ecre
tari
at a
nd h
ost c
ount
ry -
Tai
wan
for
thei
r sp
onso
rshi
p an
d or
gani
zing
th
is tr
aini
ng C
ours
e
****
****
**
Th
an
k yo
u f
or
you
r a
tte
nti
on
!
Ack
now
ledg
men
t
139
1
Metrical control on Sphygmomanometers in Vietnam
Bui Trung Dung
Metrology Department of Directorate for Standards and Quality of VietNam (STAMEQ)
Good morning/afternoon everybody,
My name is Bui Trung Dung, an expert of metrology managing, Metrology Department, Directorate for Standards and Quality of Vietnam.
My main job is to assess documents, approve patterns of different means of measurement to be imported and produced in Vietnam.
In my presentation, I would like to mention about the current use of Automated Sphygmomanometers in my country and the metrical control on Automated Sphygmomanometers in Vietnam.
1. Brief introduction of juridical metrology in Vietnam
Nowadays, the International System Units (SI) is admitted as the unique juridical system of Measurement in Vietnam and is allowed to use in the entire country by the Vietnamese government. The Directorate for Standards and Quality is the state appropriate
authority, which belongs to the Ministry of Science and Technology, takes responsibility to do consultant works for the government about measuring issues on the national scale including measuring units, national measuring standards system, and means of verification
140
2
and calibration as well as to represent Vietnam in international and regional meetings in the fields concerned.
2. Metrical control on Sphygmomanometers in Vietnam 2.1. The use of Automated Sphygmomanometers in Vietnam
Sphygmomanometers have been widely used to measure blood pressure of people in Vietnam for many years. According to the statistical data in 2004, there are approximately over 38,000 sphygmomanometers used in the hospitals in Vietnam, including two types of blood pressure equipment non-automatic and automatic equipment. Non-automatic equipment includes Mercury and Aneroid equipment which account for over 90% of the total number. The rest is automatic ones.
The non-automatic equipment are used fairly commonly in hospitals and health centers, but the automatic ones are not. There are many reasons for that situation. However, the main factor is that most of the equipment, which are being used in clinics are old types, not modern. Another important reason is that many of the Vietnamese medical personnel and doctors consider that automatic sphygmomanometers usually give the unstable results.
Nevertheless, automated sphygmomanometers are used commonly in families as home monitoring for its advantage of easy to use. For the people, who are high blood pressure, this type of equipment is very necessary for them to monitor their daily blood pressure stage. It is easy to buy an automated sphygmomanometer with a price from 30 - 100 USD in many medical equipment stores in Vietnam. Most of the equipment sold are imported to Vietnam from China, Malaysia, and Japan with different models and labels such as OMRON, Siemens, etc. The model OMRON RX-M2 is preferable in Vietnam for its good quality although the price is pretty high.
2.2. Legislative control on Sphygmomanometers in Vietnam
As we know, sphygmomanometer is a mean of measurement relates to the health of people. Therefore, Vietnam has a regulation document (Numbered 65/2002/QD-BKHCNMT) stipulating sphygmomanometers in the list of equipment to be controlled by the state management, specifically, the appropriate authority of Metrical Management. Any organization or individual business, who wants to produce or import sphygmomanometers into Vietnam, has to take the pattern approval by the appropriate authority of Metrical Management.
The Directorate for Standards and Quality (STAMEQ) is the appropriate authority takes the duty to organize a pattern approving, measuring aspect controlling and inspecting for sphygmomanometers. We also decide whether an equipment have to be initially or subsequently verified at the state appropriate authority of verification.
At present, we can only verify the non-automated sphygmomanometers. Procedure of verification for Aneroid and Mercury sphygmomanometers is carried out on the technical document numbered 53:1999. Following is the traceable hierarchy for those devices implemented in Vietnam
141
3
However, for the automated equipment, we are not able to deploy verification because most of the equipment are being used at households, so the need of verifying is not much. Further more, we don't have measuring standards and technical documents for verifying automated equipment.
3. Expectation
In near future, when the quantity of Automated Sphygmomanometers is increased in hospitals, clinics and households, we find the verification for these devices will be a very urgent task and will receive the special interest by the Government.
Researching on the application of recommendation OIML R16-2 and the related documents to edit the procedure of verification for automated sphygmomanometers are very necessary for the measuring management bodies in Vietnam.
142