What edition of the IEC 60601-1 standard is required?

[ganglai]

I was trying to get my head around what edition of the IEC 60601-1 standard is required on European Commission\harmonised standards for medical devices page

There are the following notes:

Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.
The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31/12/2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31/12/2015. As from 01/01/2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.

What edition of the IEC 60601-1 standard is required?

Thanks for your help in advance!

 

[hcrook]

IEC 60601-1 3.1 Edition (harmonized as EN 60601-1:2006/A1:2013) is best to apply since its transition date for the EU is December 31, 2017. That is to say, after the transition date, compliance with IEC 60601-1 3.0 edition (EN 60601-1:2006) will no longer be accepted as Evidence of Conformity with the Essential Requirements of the MDD.

 

[crumble]

In your opinion, does this mean that for medical devices in conformity with IEC60601-1 ed.3, already on the market in Europe, the IEC60601-1 tests must be updated according to the latest version?

 

[ganglai]

I would say Yes is the answer. We have had experience that CE marked product had to remove CE marking because of not being able to demonstrate compliance to latest harmonised standard.
But I would love to know how many companies are strictly following the latest harmonised standards.

 

[Ronen E]

I would say Yes is the answer. We have had experience that CE marked product had to remove CE marking because of not being able to demonstrate compliance to latest harmonised standard.
But I would love to know how many companies are strictly following the latest harmonised standards.

That sounds a little strange to me.
If there are more than one version that are harmonized, you should be able to use any, not necessarily the latest amongst them. Once an older version ceases to be harmonized, you must of course move on to a newer one that is still on the list.

Theoretically a company can also be in compliance (and eligible for CE marking) while applying an older, non-harmonized standard (especially one that was harmonized not long ago), because the directive's requirement is compliance with the ERs, taking consideration of the state-of-the-art, rather than a strict requirement to apply harmonized standards; but I can see how in practice that would be difficult to pull off in the context of 60601.

 

[ganglai]

That sounds a little strange to me.
If there are more than one version that are harmonized, you should be able to use any, not necessarily the latest amongst them. Once an older version ceases to be harmonized, you must of course move on to a newer one that is still on the list.

Standards always allow for transition period and everyone understands. It could've clarified the word "latest" in the reply....

Theoretically a company can also be in compliance (and eligible for CE marking) while applying an older, non-harmonized standard (especially one that was harmonized not long ago), because the directive's requirement is compliance with the ERs, taking consideration of the state-of-the-art, rather than a strict requirement to apply harmonized standards; but I can see how in practice that would be difficult to pull off in the context of 60601.

I agree with the theory. But in practice, it could end up CE mark being removed. Or it could also be ok.

 

[marmotte]

Interested in this discussion too.

Hi Ronen

My understanding is that compliance to the current/latest harmonized standard gives you a presumption of compliance to the ER/EP without the need for further documentation.
If this is not achieved, i.e. if there is only compliance/certification to a legacy harmonized standard, (or even to no standard at all), then the manufacturer must justify/demonstrate compliance with the EP through documented evidence.

60601-1 (and whole series) is about safety and efficacy which is a very comprehensive topic. Without at least the legacy standard I think it would be pretty much impossible to demonstrate that safety and efficacy is up to par (except maybe for some very specific extremely simple products which are considered electrical for whatever reason but not really relevant to 601 - not that I could think of anything ???? ). Anything with a power plug or a battery would definitively need to comply with / be certified to the 2nd edition of 601 + to document through a gap analysis that the new/modified requirements of the 3rd (or 3.1) do not raise any concern compared with the 2nd ed.
At least that has been my understanding so far - and the way one of the products I am in charge of is documented ... So any comments are welcome....