strategic approach for iso rpdarbetsliv.de/region_9/ftf-2013-10-22/ronner iso tc94 sc... · 2014....

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22/10/2013 1 ISO TC 94 SC 15 - PROGRESS REPORT ISO-RPD/www (what, when, why?) progress report Lars Ronner Chairman TK 400 2013-10-21 Overview on Standardization of Respiratory Protective Devices (RPD) ISO TC 94 SC 15 - PROGRESS REPORT Who are the partner ? Participating countries (P-members): 21 Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Korea (Rep.) Mexico, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, USA, Great Britain Observing countries (O-members): 4 New Zealand, Romania, Serbia, Slovakia

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Page 1: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

1

ISO TC 94 SC 15 - PROGRESS REPORT

Strategic Approach for ISO RPD

ISO-RPD/www (what, when, why?)

progress reportLars Ronner Chairman TK 400 2013-10-21

Overview on Standardization of Respiratory Protective Devices (RPD)

ISO TC 94 SC 15 - PROGRESS REPORT

Who are the partner ?

Participating countries (P-members): 21

Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Korea (Rep.) Mexico, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, USA, Great Britain

Observing countries (O-members): 4New Zealand, Romania, Serbia, Slovakia

Page 2: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

2

ISO TC 94 SC 15 - PROGRESS REPORT

1 Standard for Terms and Definitions

8 Documents about “Human Factors”

2 Performance Standards (Filtering - and Supplied breathable gas RPD)

1 Standard for Thread Connector (Filter & RI)

15 Test method Standards

3 Standards for Selection & Use

30 Documents

ISO WORK PROGRAM

Which documents are in preparation?

ISO TC 94 SC 15 - PROGRESS REPORT

R Leonardo da Vinci 1452-1519

Protection

Protection

wearer

Environment

Hazards

WEARER FOCUS AND SYSTEM APPROACH

What is wearer-focus?

ISO-RPD-Standardization

follows the W e a r e r

focus based on Human

Factors for protection against all threats of

working environment

ISO-RPD-Standardization

is based on a System Approachexception:Filter and RespiratoryInterface with Standardized Connector

Performance Characteristic

will tie into Classification and a selection procedure

will use the appropriate class of RPD with the adequate performance

Page 3: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

3

ISO TC 94 SC 15 - PROGRESS REPORT

from product orientated standardization ….

…to performance orientated standardization!

Change in concept:

to

P e r f o r m a n c e

…from more than 40 RPD-Product-Standards to only 2 main RPD-Standards!

NEW APPROACH

ISO 17420 – 1, Supplied Breathable Gas RPD , ISO 17420 – 2/3, Filtering RPD/Thread

What is new?

ISO TC 94 SC 15 - PROGRESS REPORT

Breathable Gas Capacity

Total InwardLeakage

Work Rate

Gas Filter Type/Capacity

Particle Filter Type/Efficiency

What are

typical

Performance Characteristics ?

PERFORMANCE CHARACTERISTICS OF RPD

Breathing Resistance

Work of Breathing

Page 4: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

4

ISO TC 94 SC 15 - PROGRESS REPORT HUMAN FACTORS-ISO 16976 SERIES

Human Factors…

…are the foundation of the ISO RPD Standardization

HumanISO 16976

Factors

Psyco-logicalEffectspart 6 Meta-

bolicRatespart 1

Anthro-pometrics

part 2CO2-O2 limitation

part 3

Work ofBreathing

part 4

ThermalEffectspart 5

Hearing& Speech

part 7Ergonomics

part 8

What are Human Factors?

ISO TC 94 SC 15 - PROGRESS REPORT

Definition of wearer group:5 to 95 perzentile, based on the Gauss Distribution of all RPD wearers, female and male, in the age of legal employment in their working environment

std.NormV( m = 5,00; s = 2,00 )

0

0,2

0,4

0,6

0,8

1

1,2

0 1 2 3 4 5 6 7 8 9 10 11

50 %

5 % to 95 %

5 % (female) 95 % (male)

R ISO/TC 133/N0031 Definition of Virtual Human Body

DEFINITION OF WEARER GROUP

Who are the wearer?

Page 5: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

5

ISO TC 94 SC 15 - PROGRESS REPORT

Minimum Frontal BreadthFace WidthBigonial BreadthFace LengthInterpupillary BreadthHead BreadthNose ProtrusionNose BreadthNasal Root BreadthMenton-Subnasale Length

12345678910

10 MEASUREMENTS FOR PRINCIPLE COMPONENT ANALYSIS

16976

Anthro-pometrics

part 2

Anthro-pometrics

part 2

How to describe the human face?

ISO TC 94 SC 15 - PROGRESS REPORT

10

20

30

40

50

240 260 280 300 320

First Principal Component

Sec

on

d P

rin

cip

al C

om

po

nen

t

R NIOSH-NPPTL

S = small; M = medium; L = large; SW = short/wide; LN = long/narrow

Head forms in relation to segmentation of wearer‘s distribution

TIL-TEST PANEL SELECTION - HEADFORMS

small

large

med- -ium

S W

L N

LMS

Anthro-pometrics

part 2

ISO 16976

Chineese distribution

From more than 3000 head scans 5 test headforms have been derived, each representing a cell in the Principle Component Analysis (PCA-panel)

selection of test subjects distributed to the PCA panel cells according

to the size of RPD

ISO 16900 part 1: Inward –Total Inward Leackage Test method

Page 6: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

6

ISO TC 94 SC 15 - PROGRESS REPORT MINUTE VENTILATION & WORKRATE CLASSES

How much breathable gas does the wearer needs for his/her task?

The minute ventilation and the designated work rate classes [W]

W4: maximal 135 l/min (45 [1/min] x 3 [l] ) for 5 minutes only

W3: extremely heavy 105 l/min (42 [1/min] x 2,5 [l] )

W2: very heavy 65 l/min (32,5 [1/min] x 2 [l] )

W1: moderate 35 l/min (23,3 [1/min] x 1,5 [l] )

Meta-bolicRatespart 1

16976

ISO TC 94 SC 15 - PROGRESS REPORT

e Body (Suit)d Head (Hood)c Face (Full Face mask / visor)b Mouth and Nose (Half mask)a2 Mouth only (Mouth piece)a1 Nose only

CLASSES OF BARRIER LINES & PROTECTION LEVEL

T (tight)L (loose)

barrier line class

class TIL [%]

PL 6 0,001

PL 5 0,01

PL 4 0,1

PL 3 1

PL 2 5

PL 1 20

Protection Level class [PL]

newknow

n

CENTIL

_[%]_0,050,10,20,51251020

What are the new classes for Respiratory Interfaces?

Page 7: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

7

ISO TC 94 SC 15 - PROGRESS REPORT CLASSIFICATION & PERFORMANCE CHARACTERISTICS

the RPD is capable to protect the wearer at the metabolic rate the wearer demands for the application/task(s)

=

=Protection

ClassClass

123456

PC W

+specifics for

supplying filtering or breathable

gas

+

Basic Performance Characteristics

1

2

3Application Workrate

Class

4

123456

1

2

3Application Workrate

Class

4

Res

pir

ato

ryIn

terf

ace

RI

a T/L

b T/L

c T/L

d T/Le T/L

Special Application Performance Characteristics

One classification for all RPD !

MiningFire

FightingCBRN Marine

Abrasive Blasting

Weldingabnormalpressure

Escape

FF CBRN MN MA AB WE AP ES

ISO TC 94 SC 15 - PROGRESS REPORT CLASSIFICATION BASIC PERFORMANCE CHARACTERISTICS

F

gas:type/ class

1

2

3

4

300

1000

3000

90009000

3

4

1000

abbriv. + class

Supplied Breath -able Gas RPD

Protection LevelClass

123456

PL W S [liters] YS

So

urc

e

or

Sourceexamples for marking (SCBA) : PL5 W4 cT S 1600(Airline) : PL3 W3 dL SY

examples for marking: PL4 W1 cT F2 AC3PL3 W2 bT F3 AC2BC1w2

Basic Performance Characterics

with Standardized Connector

Protection LevelClass

123456

1

2

3Application Workrate

Class

PL WFiltering RPD

4

1

2

3Application Workrate

Class

4

Res

pir

ato

ryIn

terf

ace

RI

a T/L

b T/L

c T/L

d T/Le T/L

Res

pir

ato

ryIn

terf

ace

RI

a T/L

b T/L

c T/L

d T/Le T/L

filtering eFficiency

123

4

5

MiningFire

FightingCBRN Marine

Abrasive Blasting

Weldingabnormalpressure

Escape

Special Application Performance CharacteristicsFF 5 Structural A2FF 4 Structural A1FF 3 HazardousFF 2 RescueFF 1 Wildland FF CBRN MN MA AB WE AP ES

FF 5

Page 8: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

8

ISO TC 94 SC 15 - PROGRESS REPORT ISO 17420-3 THREAD CONNECTION

further requirements for filters:• size limit• weight limit• breathing resistance acc. to class

17420 – 3 Thread Connection

ISO TC 94 SC 15 - PROGRESS REPORT FILTER MARKING

filter colour code

TODAY

Particle Filter

Particle Filter

Organisch (A)

Organic Vapours(OV)

Anorganisch (B)

Acidic Gompounds (AC)

Saure Gase (E)

Ammoniak (K)

Basic Compounds (BC)

Specific Gas Filters

F4w2 OV3 BC3 AC3 HCN3w2

Logo

Logo

TOMORROW

blue: gas filterwhite: particle filter

Page 9: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

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ISO TC 94 SC 15 - PROGRESS REPORT ALLOWED CONFIGURATION

Respiratory Interface: part of the system but with additional requirementsas component on its own, when standardised connectoraccording to ISO 17420 – 3 is used

http://www.draeger.com/media/10/03/13/10031392/090619_draeger_review_97.pdf

ISO TC 94 SC 15 - PROGRESS REPORT

http://www.draeger.com/media/10/03/13/10031392/090619_draeger_review_97.pdf

No ISO-Thread Connection for Supplied Breathable Gas Devices with negative pressure mode

Consequences of the exceptionRI - Thread Connection - Filter:

Why: the RI with -marking has only limitation onpeak pressures, no dynamic interface characteristicsspecified, performance charateristic of LDV is not supported in all possible cases

RPD system

Page 10: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

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ISO TC 94 SC 15 - PROGRESS REPORT SELECTION -USE - MAINTENANCE

Hazard Assessment

Adequacy Assessment

Suitability Assessment

Risk

Assessment

ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

How to select the adequate and suitable RPD for your application/task?

RPDspec

ISO TC 94 SC 15 - PROGRESS REPORT WORK ITEM CONTROL PLAN ISO 17420-1 SBG-RPD

020712

1st Committee Draft 2nd CD

240913

24.03.2011

240314

Draft International Standard (DIS)

240115

Final DIS

240615

Publicationvoting -

delay 10 month

When will the new ISO-Standards been published?

target new target

Page 11: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

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11

ISO TC 94 SC 15 - PROGRESS REPORT

future ISO Standards

todays EN Standards

CE Certification: - based on EN

CE Certification based on PPE-Directive & ISO Standards

EN ISO Standards

prepare „Annex ZA“-Document

new EN xxx covering “remaining issues”

2015

- based on EN ISO

prepare new EN xxx Standards“remaining issues”

Transition periode: up to5 years

CHANGEOUT PROCESS

1. review

after 3 yrevision?

3 years

deci

sion

: go

EN

ISO

IS

How and when will ISO affect European Market?

ISO TC 94 SC 15 - PROGRESS REPORT STANDARDIZATION TRENDS

• …because wearer needs to know which performance level of an RPDis the most adequate for the application/task to protect them

Why does the wearer need a new standard?

• …because wearer needs support in establishing and implementinga RPD program through recognized industrial standards

• …because wearer needs help in selecting the adequate and suitable RPD

• …because the harmonised classification system allows waerer to

compare performances amongst RPD types

Page 12: Strategic Approach for ISO RPDarbetsliv.de/Region_9/FTF-2013-10-22/Ronner ISO TC94 SC... · 2014. 11. 29. · ISO 16975-1 Respiratory Protective Devices-Selection, Use and Maintenance

22/10/2013

12

ISO TC 94 SC 15 - PROGRESS REPORT

• …because there are no International Standards for RPD existing worldwide

Why do we need new ISO-Standards for RPD?

The protection of the wearers is in the focus of ISO RPDand that is called:

Human Factors driven standardization!

• …because there is a need to define and establish equal protection levels for wearers in any workplace regardless of world‘s location

• …because gaps of existing standards have to be closed

DELOYMENT IN STANDARIZATION

ISO TC 94 SC 15 - PROGRESS REPORT

• …because ISO Standards have a good chance to remove barriers to world trade !

Why does the world need new ISO-Standards?

I S OR P D

for a better protection