Understanding Versions of Collateral and Particular Standards

[Mark Meer]

Hi Everyone,

I'm trying to get my head around how versions of collateral and particular standards of relate to the general 60601-1 version...

Is there a simple relationship?

For example:

Europe currently has "EN 60601-1:2006/AC:2010 (IEC 60601-1:2005 Mod)" and "EN 60601-2-10:2000 (IEC 60601-2-10:1987)" listed as harmonized standards.

Whereas the FDA has "AAMI / ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012 And, A2:2010/(R)2012 (IEC 60601-1:2005, Mod)" and "IEC 60601-2-10 Edition 2.0 2012-06" listed as consensus standards.

So, both seem to be recognizing a 3rd-edition variant of the general standard, but for the particular standard (-2-10), Europe is recognizing the 1st edition (1987), whereas the US FDA is recognizing the 2nd edition (2012).

Is this correct? If so, it appears that the version of the general standard has no bearing on the versions of particulars and collaterals you choose...

 

[PaulGr]

From IEC60601-1:2012: Applicable collateral standards ... shall apply together with this [IEC60601-1] standard. (...) A requirement of a particular standard takes priority over this [IEC60601-1] standard.

So check the references of applicable particulars and collaterals to decide which version of the general standard IEC60601-1 should be used. You can only select versions of the general standard, collaterals and particulars that belong together and you have to start with the version of applicable particular(s).

The issue i.m.o. is with the adoption of new standards by the authorities. Looking at the lists of harmonized (EU) we have not seen an update of the list of harmonized standards since January 2013. As a result, specific particulars aligned with 60601-1 3rd edition or 3.1 are available on IEC level but for a CE conformity assessment we still have to use particulars aligned with the 2nd edition and as a result also the 2nd edition of the main standard.

Any other thoughts on this subject?

 

[Mark Meer]

...we still have to use particulars aligned with the 2nd edition and as a result also the 2nd edition of the main standard.

This is precisely what is confusing me.

IEC 60601-2-10:2012 (2nd Ed.) clearly states it is aligned with IEC 60601-1:2005+A1:2012 (3rd Ed.)

IEC 60601-2-10:1987+Am1:2001 (1st) states alignment with the 2nd edition of the general standard.

So: if the EU is presently listing only 60601-2-10 (1st edition) as harmonized, but is NOT listing the edition of the general standard to which it is aligned (i.e. 60601-1 2nd Ed.), what are you supposed to do??

 

[medgar]

Hi

Care needs to be taken when using the 60601 series if your 'end game' is conformity to the MDD because there are now a number of 'current' stds in the 60601 series referencing different versions of each other (some of which do not give a presumption of conformity to the MDD).

For example, the OJEU now annotates EN 60601-1 (3rd Ed) as 'compliance with this standard may not give a presumption of conformity to the MDD'.

The consensus with my colleagues is that, in this case, it is most likely due to the 3rd edition reliance on ISO 14971:2007 rather than EN 14971:2012 => the treatment of risk is quite different between these standards.

We've found that we need to check that the standard is hamonised AND still gives a presumption of conformity if we are looking for conformity to the MDD.

 

[Mark Meer]

Thanks for the tip medgar, I'll pay close attention to which harmonized standards are expired or have notes regarding presumption of MDD conformity...

EN 60601-1:2006/AC:2010 seems to be ok...

But my real concern here is with versions. If applicable, we are supposed to start with an applicable particular standard, in this case -2-10.

Now we find that only the 1st edition (ammended) is harmonized. ...and this aligns with the 2nd edition of the general standard, which is no longer harmonized.

So, what to do? Do we:
1. Go with the harmonized particular, and then test to the 2nd edition of the general standard assuming that because it is aligned with the harmonized particular this will be ok.
OR
2. Go with the latest (not-yet-harmonized) particular that is aligned with the 3rd edition (harmonized) of the general standard.
OR
3. Do both 2nd and 3rd edition testing (this is what our test lab is recommending...of course)

 

[PaulGr]

So, what to do? Do we:
1. Go with the harmonized particular, and then test to the 2nd edition of the general standard assuming that because it is aligned with the harmonized particular this will be ok.

For MDD compliance, this might be a safe option as long as you don't need compliance with IEC 3rd edition standards in the rest of the world. This is also conform the NB-MED recommendation (see 60601-1 FAQ 3.5.4).

2. Go with the latest (not-yet-harmonized) particular that is aligned with the 3rd edition (harmonized) of the general standard.

Before choosing this route, I would discuss the approach with your notified body (if they are involved) to ensure they accept these standards as an alternative to the harmonized standards. (Because of the EU quarrel about the harmonized standards we have this strange situation without updates of the list).

3. Do both 2nd and 3rd edition testing (this is what our test lab is recommending...of course)

This will be required if you need both sets of reports to get approvals in your target countries. I think currently only Canada and Brazil are to be checked if they need 3rd edition reports.

 

[Pads38]

As harmonisation of 60601-2-10:2012 is long overdue I would "future proof" my testing and use the newer versions of both the particular and the general standard.

I would then highlight in my Technical Files that the -2-10 Test Report has been issued before harmonisation but that it provides an acceptable alternative approach. I don't think a Notified Body would argue much with that. You could even do a side-by-side clause comparisons to show that there is not a great deal of technical difference.

Remember ALL standards are voluntary.
The "Essential Requirements" are the compulsory thing.

 

[Peter Selvey]

Technically, when a particular standard exists, there is no "general standard" as such. The particular is merged with the general standard to create a single standard e.g. IEC 60601-2-10:1987. Therefore, there is no need for Europe to keep the old version of general standards (e.g. EN 60601-1:1990) in the list of harmonized standards.

But anyway in this particular case I would go with the latest edition if possible, even though not harmonized.

The problem is that change from old to new is so dramatic that it would be difficult to try to cover both old and new editions. Also we can expect the new standard to be harmonized soon.

For Europe, it is misleading or simplistic to say that "all standards are voluntary". The law states that if you do not use harmonized standards you need to document your "alternate solutions" against the essential requirements. There is no obligation to do this when harmonized standards are used. Although most manufacturers will have a "essential requirements checklist" these are usually poorly prepared and lacking any detail, which is fine as long as harmonized standards are used, since it is not required anyway. The minute you decide to go "off-road" so to speak, this becomes a formal legal document, so it needs to be prepared carefully.

The key point in this case would be to identify any area in which the older standard is more strict than the latest standard. In that case you would need to show the alternate solution (e.g. new standard) meets the essential requirement.

For some standards, Europe has genuine concerns so they may be deliberately holding back on harmonization. ISO 80601-2-56 for thermometers has been around for nearly 5 years but not yet harmonized, and there are some serious conflicts with the existing older standards.

However for IEC 60601-2-10, I don't know of any such conflict, it may be just a delay for the committee to get around to the IEC version, and Europe would like give a period of grace (e.g. 3 years) before harmonizing. Why no period of grace for FDA? The answer is that standards are not part of the law in the US, they are just guidance for smoother applications. So the FDA can change the list quickly without any legal impact.

In summary I would go with the latest standards, and for Europe I would prepare a short report that outlines any significant changes between 1987 edition and the 2012 edition. For any point where the 1987 edition is more strict than the 2012 edition, explain why the related essential requirement(s) is/are met. In your essential requirements checklist, make reference to the actual reports for the standards and also the report on the assessment of significant changes.

Don't ask the NB if this is OK. Just do it.