Retrospective Application of EN 60601-1:2006 - Harmonized Standards

Ronen E

Problem Solver
Staff member
Moderator
#21
I think this is a really interesting discussion....

Although it is true that harmonised standards are not required, past experience with our NB (and I'm sure it won't just be limited to just ours) is that they are very resistant alternate approaches to demonstrating compliance if a harmonised standard exists. I would say MEDDEV's also fall under this category.

I would hope that if we pushed hard enough they would back down but to be honest the effort necessary so far has not made it worthwhile.
Another reminder: The MDD includes an official route for resolution of disputes with a NB. I find it unacceptable that a NB operates against the spirit of the MDD. Perhaps you should appeal to the CA just once.

BTW, if your "alternative" solution is compliance with an older version of a harmonized standard, all you have left for addressing is the gap.
 
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PaulGr

#22
One little reminder: Compliance with harmonized standards is not mandatory. It is compliance with the ERs which is mandatory. If you have another way to show that a device is compliant with the ERs (based on state of the art and a high level of public health and safety assurance) you should be OK.
Very true. You won't act against the law after June 2012 when not all your products are compliant with the 3th edition. But if you have not even started with an impact analysis, you will definitely be in trouble after your next NB audit.

So, a good plan and starting with compliance testing for your older products will probably help you better than a more fundamental discussion about the 'whereas' section.

And if notified bodies plan to be flexible with respect to existing products, they will for sure not make that public. :rolleyes:
 

pkost

Trusted Information Resource
#23
How about from this perspective...As ronen has pointed out - you are legally obliged to demonstrate compliance with the essential requirements (not the standard).

The essential requirements have not changed therefore how can you suddenly be non compliant? You are required to consider the state of the art but how has the state of the art changed here? It will vary between different products, some will have significant advances, some none.

My background is not electrical so I don't know about the 2nd edition but my question would be how does the 3rd edition advance the state of the art?
 

Peter Selvey

Staff member
Super Moderator
#24
One little reminder: Compliance with harmonized standards is not mandatory. It is compliance with the ERs which is mandatory. If you have another way to show that a device is compliant with the ERs (based on state of the art and a high level of public health and safety assurance) you should be OK.
The issue here is resources, not compliance. Compliance with standards is voluntary. Evaluating your compliance status is not. So in terms of resources, the voluntary nature of standards has little impact.

Each conformity Annex of the MDD requires (by law) that where harmonized standards are not applied, alternate solutions must be documented against applicable essential requirements.

Thus, if the NB interpretation is right, on June 1, 2012 your legal options are:
1) comply with EN 60601-1:2006, or
2) document alternate solutions to EN 60601-1:2006

But the catch here is that standards typically cover many individual aspects of a variety of essential requirements. As such, alternate solutions must be documented on a requirement by requirement basis, not standard by standard basis. The CB scheme protocol for IEC 60601-1:2005 lists around 1,500 individual requirements.

Moreover, you will find that most alternate solutions take the form of modification of limits or test methods. So the tests are still required, but just modified. Simply ignoring the whole requirement altogether because they are voluntary is not going to fly. You have to look at the requirement in the standard, explain why it does not make sense for your device, and propose an alternate criteria. That's a lot of work for 1,500 requirements, applied retrospectively to 10,000's devices being placed on the market.
 

Ronen E

Problem Solver
Staff member
Moderator
#25
The issue here is resources, not compliance. Compliance with standards is voluntary. Evaluating your compliance status is not. So in terms of resources, the voluntary nature of standards has little impact.

Each conformity Annex of the MDD requires (by law) that where harmonized standards are not applied, alternate solutions must be documented against applicable essential requirements.

Thus, if the NB interpretation is right, on June 1, 2012 your legal options are:
1) comply with EN 60601-1:2006, or
2) document alternate solutions to EN 60601-1:2006

But the catch here is that standards typically cover many individual aspects of a variety of essential requirements. As such, alternate solutions must be documented on a requirement by requirement basis, not standard by standard basis. The CB scheme protocol for IEC 60601-1:2005 lists around 1,500 individual requirements.

Moreover, you will find that most alternate solutions take the form of modification of limits or test methods. So the tests are still required, but just modified. Simply ignoring the whole requirement altogether because they are voluntary is not going to fly. You have to look at the requirement in the standard, explain why it does not make sense for your device, and propose an alternate criteria. That's a lot of work for 1,500 requirements, applied retrospectively to 10,000's devices being placed on the market.
As mentioned before, if you're already in compliance with the 2nd edition, you should be fine addressing only the gap. I bet it's a bit less than 1,500 req.
 

Peter Selvey

Staff member
Super Moderator
#26
TUV SUD's analysis indicates there are 1,422 requirements, of which 693 are new or more strict.

As the structure of the standard is completely revised a classic "gap" approach does not work, in practice each of the 1,422 requirements needs to be re-checked and re-documented. But it is true that in many cases the test data from 2nd ed assessment can be still used to support compliance, saving considerable time and cost.

Experience indicates there are around 30-50 open points requiring new tests, new documentation or re-design after an initial scan of all 3rd ed requirements and using 2nd ed data.
 

Ronen E

Problem Solver
Staff member
Moderator
#27
...in many cases the test data from 2nd ed assessment can be still used to support compliance, saving considerable time and cost.

Experience indicates there are around 30-50 open points requiring new tests, new documentation or re-design after an initial scan of all 3rd ed requirements and using 2nd ed data.
Not to say that there is no issue, but the above sounds a bit more balanced. Given that the 3rd edition was issued about 6 years ago and its harmonization was not unpredictable, I'd say that any organization with a bit of forward-thinking could have handled the above within a reasonable effort.

BTW, I have absolutely no affiliation with any testing / certification body dealing with 60601.
 

Peter Selvey

Staff member
Super Moderator
#28
I agree, it's not too bad for someone familiar with the 2nd ed, doesn't mind making 200 page reports, and is flexible with the bugs in the standard.

I made a mistake to emphasize resources for EN60601-1:2006.

The original point of the thread (and the article) is to show that retrospective application of all harmonized standards is impossible.

If so, then it inconsistent to apply it to high profile standards like EN 60601-1:2006. The resources for EN 60601-1 is a trigger for the analysis, but not the proof.

It was pointed out that standards are voluntary, but this is does not affect the debate, since by law you still have to evaluate your compliance status in order to identify specific alternate solutions.

So that still leaves the original point standing: since retrospective application is broadly impossible, why apply to EN 60601-1:2006?
 
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