application of iec 60601-1:2005 - tuv-sud.co.uk · webinar application of iec 60601-1:2005 part 1:...

TÜV SÜD Product Service GmbH Copyright by TÜV SÜD

Webinar Application of IEC 60601-1:2005Part 1: General requirements for basic safety

and essential performance

Speaker Alberto Paduanelli

Medical Devices Lead Auditor MHS-UK

Tel: +44 (0)1489 558219

[email protected] www.tuvps.co.uk

TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 2

General Information:

• Time of presentation: 45-50 min.

• Question & answer time at the end: 10 min.

• You will get this whole presentation as pdf-file after the

webinar via email.

• Some pages will not be commented, marked with:

1-Dec-11


CONTENT - Modules:

General information about the 3rd Edition

Transition period of the 3rd Edition

News related to mechanical safety testing

New concept, changes and effects for manufacturers

Next steps for implementation

1-Dec-11


Module 1

General information

about the 3rd Edition

1-Dec-11


WHAT IS THE 3rd EDITION ?

51-Dec-11


Consequences:

Too many changes in the most important general basic standard in

one single step (2Ed 3Ed) have created the following problems:

- Some markets & their authorities have not (yet) accepted

the 3rd Edition (e.g. USA: OSHA, China: SFDA).

- Mistakes in the standard.

- Gaps in the standard.

- Unclear requirements in the standard.

Addition:

- New structure e.g. clause 15.b residual

voltage at the plug has become clause 8.4.3.

- The 3rd Edition was written by different working

groups.

1-Dec-11


Solutions:

Worldwide different parties are working on solutions, e.g.:

- A1PMT and their WG's and MT's Amendment 1.

- IECEE-RM-TF RM & TRF in the CB scheme.

- National committees e.g. DKE, replacing RM links by clear

Pass/Fail requirements.

- Corrigendum

- ......

1-Dec-11


CDV: IEC A1

March 2011 June 2012

Around 200

change requests

have been

discussed.

1-Dec-11


Module 2

Transition period

of the 3rd Edition

1-Dec-11


EUROPE

• Law basis is the directive MDD 93/42/EEC.

• Annex I contains the Essential Requirements (ER).

• Objective evidence of compliance with the ER is demonstrated by:

A) Harmonized standards (> 99% used):

The reason, why usually harmonized standards are taken, is their

presumption of conformity with the ER less discussions!!

B) Other sources (< 1%, used only in exceptional cases, and even

then only for a few single clauses of a harmonized standard):

Deviations from harmonized standards must be justified &

documented create questions!!

101-Dec-11

TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 111-Dec-11


159 pages: TRF

- 104 pages: requirements,

- 55 pages: tables for results

104 pages x 13,6 requirements

per page = ca. 1422!

How many

requirements are we

talking about?

1-Dec-11


Requirements:

- The 3rd Edition contains exactly 1422 single requirements, each has

to be verdict by PASS // FAIL or N/A.

- Thereof are 729 requirements identical or even less stringent as in

the 2nd Edition. Measuring results & verdicts of 2nd Edition can be

transferred to the 3rd Edition TRF.

- However there are 693 requirements in the 3rd Edition totally NEW

or MORE STRINGENT than in the 2nd Edition. That is ca. 50%!!!

new measurements and/or new verdicts and their documentation are

required.

1-Dec-11


2Ed TRF

+

+

RM

Vigil-

ance

system

≠

141-Dec-11


Based on:

- 3 times longer blank TRF

- 693 new or more stringent requirements

- no available delta-TRF (per IECEE resolution a delta-TRF will not

be created by IECEE!)

- Differences 2Ed vs 3Ed are in the detail (read the wording of the

standard EXACTLY!)

- 2Ed testing was often conducted several years ago and

changes on the product (under Annex II) are not documented in the

original TRF !!

- World markets require a complete 3rd Edition TRF,

The documented objective evidence of 3Ed compliance

should be demonstrated by using the new TRF 3Ed (Version „g“

from Dec. 2010), so far applicable by using raw data of 2Ed

(measurements, verdicts).

151-Dec-11


The ZLG-paper 3.5 A1 makes it extremely clear:

„The missing new assessment by the manufacturer after the end

of the „doc“ or the missing knowledge about the existence of new

harmonized standards or scientific knowhow are substantial NON-

conformities. If these NON-conformities will not be adequately

corrected, the certificates have to be suspended or withdrawn.“

(Production stop!)

The „new assessment“ requires a documented point-by-point

assessment of all standard changes.

Objective evidence: Use new TRF version „g“ (or provide

documented statements & measurements to the 693 changes

which are not covered by 2Ed).

161-Dec-11


How much time do we

have? 182 days

(at 30 November 2011).

You cannot afford to loose

ONE SINGLE FURTHER DAY!

1-Dec-11


Module 3

News related to mechanical

safety testing

1-Dec-11


Why are there so many problems with the 3rd Edition, e.g. in the

chapters of mechanical safety and electrical safety?

A validation of the standard (= testing of a few different MEE„s)

has not been conducted prior to the publication of the standard.

221-Dec-11


Example threshold test:

23

Source: TÜV SÜD Lab

1-Dec-11


2ED clause 21.6.b

20 mm down

2ED

3ED clause 9.4.2.4.3

20 mm up and down

3ED

1-Dec-11


Planned A1 solution:

3 parameters have been changed simultaneously:

Threshold 20 mm 10 mm,

Threshold gets a radius of 2 mm at the edge,

Speed 0,4 m/s 0,8 m/s.

If those changes will not lead to a PASS Method how the MEE

could come over the threshold needs to be described in the IFU

(e.g.: wedges // pulling // 4 person carrying // …..).

251-Dec-11


Module 4

New concept, changes and effects

for manufacturers

1-Dec-11


20 errors

which should be avoided when

applying IEC 60601-1:2005

271-Dec-11


ASSUMPTION:

„The 3rd Edition contains only easier requirements

than the 2nd Edition.“

ANSWER:

By EXACTLY comparing the wording

of both editions,

693 totally new or more stringent requirements exist.

…in case of any later law issue a judge wants it as well

knowing EXACTLY. Then verdicts like „similar“ are not

accepted!

NOTE: The verdict „similar“ does not exist in testing field!

281-Dec-11


ASSUMPTION:

„If my product does not comply with any requirement

(clause x.y) of the 3rd Edition,

then risk management

(PROBABILITY X SEVERITY) shall be

conducted, this will settle the case.“

ANSWER:

See next pages.

291-Dec-11


There are 1422 single requirements in the standard.

Group A:

Only 153 thereof have a direct link to RM (key-words are: RMF,

unacceptable risk, etc.). Here RM is allowed!

Group B:

All the other 1269 requirements have to be handled as in 2nd Edition.

That means concrete, that RM alone is not enough to get a PASS if a

specific clause is violated. The standard requires here to choose

the way via objective evidence of „equivalent safety, clause 4.5“.

Here the residual risk of the new risk control method must be at

least equivalent to the method prescribed in the specific standard

clause concerned. Comparing residual risks is required!

311-Dec-11


ASSUMPTION:

„Instead of the evaluation of the RM-File, it is also

allowed to conduct a process audit

according to ISO 14971.

A positive audit result leads

automatically to a PASS of all

clauses in the 3rd Edition which

refer to RM.“

ANSWER:

See next pages.

321-Dec-11


The standard clause 4.2 says:

“Compliance is checked by inspection of the RM-FILE.“

It is not allowed to replace the standard wording as follows:- Inspection Audit and- FILE PROCESS.

Auditing always means sampling. Testing means each standard clause (100%) will be verified – no sampling approach.

1-Dec-11


ASSUMPTION:

„If the MANUFACTURER will come to a result in his RM,

then this result can NOT be questioned

by other institutes like

test houses & authorities.

The standard confirms this

explicitly in clause 4.2.

Therefore the role of certifiers has changed

Changed standard philosophy =

ANSWER:

See next pages.

341-Dec-11


It is written in the standard clause 4.2:

“The policy for determining acceptable RISK*** and the

acceptability of the RESIDUAL RISK(S) shall be established by the

MANUFACTURER.” Solely the MANUFACTURER!!

“Compliance is checked by inspection of the RISK MANAGEMENT

FILE. The requirements of this clause and all requirements of this

standard referring to inspection of the RISK MANAGEMENT FILE are

considered to be satisfied if the MANUFACTURER has:

– established a RISK MANAGEMENT PROCESS;

– established acceptable levels of RISK; and

– demonstrated that the RESIDUAL RISK(S) is acceptable (in

accordance with the policy for determining acceptable RISK ***).“

The standard does not speak about evaluation conducted by third

party certifiers, like CB-labs, NRTL-labs, Notified Bodies, others.

1-Dec-11


What does “inspection” mean?:

It means that it is enough if

certifiers check that:

a) The RMF is available.

b) The RMF is complete.

It does NOT mean that certifiers

are authorized to evaluate the

correctness of the RMF.

Can certifiers agree to that?

RMF

1-Dec-11


What does the MDD require?

For example within Annex III EC Type examination the MDD 93/42/EEC requires in clause 4.1:

“The Notified Body must examine and assess the documentation and verify that the type has been manufactured in conformity with that documentation.”

Other annexes like Annex II require examination and assessment as well (Annex II, clause 4.1 – 4.3).

The MDD requires more than just “inspection”, it requires “examination and assessment”!!

1-Dec-11


What does the IECEE / CB-scheme require?

The IECEE RM training in Milan in April 2009 was organized for

all CBTL‟s and NCB‟s and IECEE assessors in the category MED

to clarify questions related to RM in the IEC 60601-1 (3Ed.).

Lecture 7 “Risk Management Responsibilities, Responsibility of

the Manufacturer and the CBTL” page 14 answers the question

very clearly:

1-Dec-11


RESULT

a) 60601-1 does NOT require RMF-evaluation by certifiers.

(at least if we ignore the “state of the art” clause 3.3 of 14971

which refers to international standards and regulations).

b) MDD & IECEE say: RMF-evaluation by certifiers is a MUST.

Both statements are in conflict with each other!

What to do?

1-Dec-11


The law has a higher level of binding (legal) character

than a standard and therefore overrules the standard.

1-Dec-11


NON RMF-evaluation

by certifiers:

2-eyes-principle-only

= not allowed for MDD

and CB approval

RMF-evaluation

by certifiers:

4-eyes-principle

= state of the art

I) Designing by manufacturer (2-eyes principle)

II) Test & Review by an independent third party (add-on 2-eyes!)

The „state of the art“ is the so called 4-eyes-principle, which means

that approval systems conduct RMF-evaluation.

1-Dec-11


If you drive too fast according the law …

“Your speed was too high!”

Sorry Sir (CBTL, NB, NRTL), you are not authorized to evaluate my speed (i.e. my RMF), I have a driver license according the 3rd Edition, here it is!

421-Dec-11

Is this how the approval systems should work?


Example: Electric shock

# Cause, Function, Effect

Hazard P (B) S (B) RISK (Before) = Initial Risk

1 240 VAC mains voltage accessible, effect on operator

Electric shock

5 5 25

RISK Control

Verify Impleme-ntation

Verify Effective-ness

P

(A) S

(A) RISK (After) = Residual Risk

Report (Objective Evidence)

- Warning label, - manual warnings

1 5 5 Report XYZ

Using descriptive safety instead of an enclosure

is violating the state of the art. This example shows

that evaluation of the RMF by an independent

organization cannot be omitted!

1-Dec-11


Conclusion:

Evaluating the RMF is required for:

- MDD (CE commission)

- CB-scheme (IECEE).

From FDA, OSHA, SFDA, etc. no written statements

are available at the moment (30th Nov 2011).

However, it is not expected that any authority will

skip “evaluation”.

The 3rd Edition does NOT change the role of

Notified Bodies, because they are bound to EU law

more than to a standard !

1-Dec-11


ASSUMPTION:

„If the standard will be applied LITERALLY then the result

is always on the safe side.”

ANSWER:

See next pages.

451-Dec-11


Clause 9.4.2.3

• LITERAL application

of the 3rd Edition would

introduce new hazards:

tripping hazards!

461-Dec-11


Clause 9.4.2.3

47

Source: DKE paper 811.1_2011-0001 dated 3. Jan. 2011

1-Dec-11

LITERAL application

of the 3rd Edition would

introduce new hazards:

tripping hazards!


ASSUMPTION:

„The limit for Earthleakage current

has been increased by the factor 10

which is easier to comply.

2Ed: 0,5 mA NC and 1,0 mA SFC

3Ed: 5 mA NC and 10 mA SFC.

ANSWER:

The new introduced Touchcurrent (0,1 mA NC // 0,5 mA SFC) will

be measured at MEE's at PE connected enclosure parts. Therefore

the limits in SFC (= PE open) are identical to the 2nd Edition of the

earth leakage current.

481-Dec-11


ASSUMPTION:

„For the operator protection (MOOP) it is allowed to take

IEC 60950 approved power supplies, there are no further

requirements for these power supplies.

ANSWER:

- Earthleakage current in 60950 is higher than in 60601-1.

- MD in 60950 is different to the MD in 60601-1.

- 60950 requires only 1 fuse in the power supply of a class I device,

whereas 60601-1 requires 2 fuses.

- The barrier „opposite polarity“ is missing in 60950.

- Test criteria in 60950 have to comply with final use criteria of the

MEE in 60601-1 (altitude, pollution degree, etc.).

491-Dec-11


ASSUMPTION:

„I have not found a 3Ed approved Power Supply (PS)

on the market. Therefore I will keep the 2Ed CB approved

Power Supply in the MEE (without upgrade

testing to 3Ed), because what

was safe in the past,

will be safe in the future as well.

ANSWER:

Mixture-certification of 2Ed Power Supply used in 3Ed MEE is

forbidden. Therefore 2Ed approved PS needs to be upgrade tested

to 3Ed.

501-Dec-11


ASSUMPTION:

For “quasi” Applied Parts according clause 4.6 it is only

required to test the barrier based on MOPP

and the patient leakage current.

ANSWER:

In addition do not forget:

- Biocompatibility

- Temperature for AP's in NC and SFC!

511-Dec-11


ASSUMPTION:

Each IFU is using „Descriptive Safety“. If these safety

instructions will not be followed, a hazard could arise.

The corresponding safety sign is

allowed to be used in black-white and

may be placed at the rear side of

the MEE.

ANSWER:

Read the standard exactly:

- 7.2.3 Inspection of the IFU is a mandatory action.

- 7.6.2 Colour of standardized symbols must be used.

- 7.1.2 Clearly legible from the intended position of the

operator.

521-Dec-11


ASSUMPTION:

Within the CB-scheme collateral standards, such like

IEC 60601-1-4, IEC 60601-1-8, ….

can be excluded.

ANSWER:

See next page.

531-Dec-11


ASSUMPTION:

The normative part of clauses 8.5.2.1 and 8.5.5.1

contains requirements which lead

to defibrillation of the operator.

Is it allowed to market such a

literally “correct” product?

ANSWER:

Apply solution

out of A1.

551-Dec-11


A “defibrillated” operator can not be justified by RMP. Take solution out of A1-CDV 2011.

561-Dec-11


ASSUMPTION:

The insulation diagram can be completed

on paper basis only,

if the voltages inside of the circuits

are known.

ANSWER:

- The WORKING VOLTAGE

according 3.139 must be

additionally measured.

- Additional influences (see

next pages) need to be

considered.

57

MP240V ~

AP 12 V-1 4

2 3

5

1-Dec-11


Additional information:- Part 2 standard applicable?

- SIP/SOP restriction in IFU?

- AP: Protective impedance needs to be checked in NC+SFC.

- IEC 60950 approval/compliance? NOT allowed to PATIENT.

- No glass, mica, ...exist.

- Application < 2000 m altitude.

- Material group IIIb.

- Pollution degree 2.

- Overvoltage category MAINS: II.

- No peaks generated.

- Defiproofed AP?

- Quasi AP‟s?

- IC, AP earthed?

- Interpolation used?

1-Dec-11


ASSUMPTION:

I will wait with pilot projects

until ALL mistakes in 3Ed are solved.

ANSWER:

Then you will wait until the A2, approximately 2016.

Almost no manufacturer has the financial resources to survive a

production stop between 2012 – 2016.

591-Dec-11


ASSUMPTION:

„An upgrade testing 2Ed 3Ed

will take 2 weeks.“

ANSWER:

- For a simple battery powered MEE MAYBE,

however in this case everything must be right at the first time:

RM, collaterals, IFU, EP, design, etc.

- If a non-compliance report will be issued 4 weeks.

- If a redesign is necessary 2-3 month.

- For a complex MEE (e.g. MRI) including part 2 standards

longer!!

601-Dec-11


The testing time is usually underestimated:

TRF scroll down ….

- every single requirement of the 1422 TRF points has to be read

- understood

- maybe the corresponding Annex A has to be consulted

- the IFU has to be checked

- clarify questions with colleagues or the manufacturer

- check the RM-file

- conduct tests & document the tests

- fill out RM tables and make final verdict

- write a non-compliance report

- TRF review by a second authorized expert

If you have done that 1422 times for a single product, then

the part 2 standard(s) & collaterals are still missing ….

Whoever claims that a normal MEE is testable within 2 weeks

has no practical laboratory experience with the standard

= has never applied the standard at an MEE by own testing.

611-Dec-11


ASSUMPTION:

I found a 36-pages DELTA TRF in the

internet which compares 2Ed with 3Ed

only related to the headings.

Can I use this instead of the 159-pages IECEE version “g”?

ANSWER:

Chapters in the 3Ed contain several requirements.

A point-by-point comparison of each of the 1422 requirements

is needed.

An exclusive heading comparison is meaningless.

621-Dec-11


ASSUMPTION:

I would like to fix-book / reserve

an 8 week testing time

for next year February - March 2012.

ANSWER:

TÜV SÜD principle: FIRST IN = FIRST TEST.

When order (1) + documentation (2) + product (3) have been

COMPLETELY received by TÜV SÜD, we will define a testing

start date & an estimation of the testing time.

631-Dec-11


ASSUMPTION:

Because I am not able to keep the

transition period, would the following

solution be acceptable?

1. I will conduct under my Annex II MDD system an

„Alibi“ 3Ed testing. Possible errors will maximum be verdict

by the NB as „minor“ NC.

2. Due to the time, which I will win, I will later conduct

a CB 3Ed testing to correct errors of my first testing.

ANSWER:

All applicable requirements of the total 1422 requirements need

to be correctly implemented when the transition time is over.

641-Dec-11


ASSUMPTION:

I have heard that the 3Ed will be

de-harmonized.

Can I trust this information?

ANTWORT:

Up to now (30th Nov 2011) there is NOT ANY hint about

de-harmonization of the 3Ed.

651-Dec-11


ASSUMPTION:

If the manufacturer is not able to comply with 3Ed

at the End of the transition period, then

this is not critical because

all involved parties are searching for

solutions.

ANSWER:

There are certain risks if such MEE will be marketed:

- Competitors could inform authorities (recall, shutdown).

!! >>Example a few are prepared.….>>!!

- Authorities could be active stop to marketing such MEE.

- In case of a law issue, the judge is not interested in any

private opinion (Example NOTE in IEC standard…..).

661-Dec-11


Module 5

Next steps

for implementation

671-Dec-11


Strategy for a fictive case:

► Date: November 2011

► 10 products on the market approved according 2Ed.

► All 10 TRF‟s of the 2Ed are brand new from 2010

(= no undocumented product changes) Unrealistic !

► Annex II MDD certified.

► Up to now, no practical experience with the 3Ed.

((… a little bit late to start …))

681-Dec-11


1. Read the standard

2. Buy IECEE TRF version „g“

3. Make a decision which products will be phase-out at the

end of the transition period, e.g. 2 old products.

691-Dec-11


4. Set free personal resources

(if you want to stay in the market after 2012)

QUALIFICATION and TRAINEE-TIMES for test engineers:

► Education: Engineer, Dr. (PhD), etc.

► Initial training, authorization, experience:

- Basic standard: 2 - 4 years

- Part 2 standard: 1 - 2 years per standard

- Specials like SW, PEMS, EP FUSA, RM: 2 years.

Don‟t use beginners for MEE product testing!

Increasing personal resources in 2011 is already

too late! (should have been conducted 2006).

701-Dec-11


5. Buy missing test equipment.

6. Study the OJ for the remaining products for which

part 2 standards allow a longer transition period

(2013, 2014, …).

7. Business analysis: Which products will get

priority „1“, based on market needs.

8. Start with the most important product.

711-Dec-11


9. One product should be tested by TÜV SÜD as a pilot

testing to gather experience. At the same time,

the same product will be tested under Annex II.

Compare the testing results point by point and discuss

them with TÜV SÜD.

10. The remaining 9 products will be tested according

Annex II.

721-Dec-11


TAKE-HOME MESSAGE:

Transition period: The MEE testing of the 693 changes of the

standard should start 2011.

Safety: If there is a clear mistake in the 3rd Edition use

e.g. the solution out of A1. To find out if

something is a clear mistake, please ask.

Effects: - Conduct a carefully point-by-point analysis

for the real 3 Ed requirements for your MEE.

- Prepare documentation and samples.

- Start pilot projects ASAP.

START TODAY, DON„T WAIT ANOTHER DAY.

731-Dec-11


Contact details:

Alberto Paduanelli

Medical Devices Lead Auditor MHS-UK

TÜV SÜD Product Service LtdOctagon House, Concorde Way, Segensworth North, Fareham, Hampshire, PO15 5RL

Tel: +44 (0) 1489 558219Fax: +44 (0) 1489 558101Mobile: +44 (0) 7740 211139

Email: [email protected]: www.tuvps.co.uk

Thank You!

1-Dec-11

THANK YOU

Alberto Paduanelli Medical Devices Lead Auditor MHS-UKTel: +44 (0)1489 558219

[email protected]

www.tuvps.co.uk

application of iec 60601-1:2005 - tuv-sud.co.uk · webinar application of iec 60601-1:2005 part 1:...

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