IEC 60601-1 1988 - Device developed in 2012 with standard of 1988

#1
Hi all,

In 2012 we developed a device, an external company has taken on the development and according to them it was still possible on 60601-1: 1988.
At the moment, the notified body indicates that we must comply with the updated version of 2006 +A12:2012

Do you have an idea how the version of 1988 was allowed to comply in 2012? Is there a way to get out of the newest version, what could be the reason at that moment to go on with the first version.

Thanks.
 
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Benjamin Weber

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#2
The 2nd edition 60601-1 from 1988/1955 was (and maybe still is?) was not only accepted but even required until at least 2015 only China as far as I know. Even though the IEC withdraw this edition. So, if you are/were placing your device on the chinese market, this may be the reason.

But without such national special situations the 3.1 edition 60601-1 (IEC 60601-1:2005+A1:2012 including corrigenda and interpretation sheets) is the only valid edition since 2018 (i think even earlier, but cand find the acutal year).

I don't see a way to go on with the 2nd edition (that the one from 1988, latest amendment/correction in 1995), as long there is no special national situation a mentioned above. Each market has some kind of database, list or similar, where you can look for the accepted standards and their editions. In Europe for example the list of harmonized standars of the medical device directive/regulation.

I can hear you ask: "But then globally operating manufacturers would have to show compliance with different editions of the same standard! That sounds crazy! That cannot be true!?!" But well, that's reality ;-)
 

Peter Selvey

Staff member
Moderator
#3
It could help to understand the history. The 2nd edition, as Benjamin pointed out, was first published in 1988 (a long time ago!) but it was last amended in 1995 (long but not as long ...).

The 3rd edition was always a bit controversial and hence it took a long time first to get it published (in 2005), next to get it into regulations and finally to reach the end of transition periods. Back in 2012 would have been towards the end of this transition zone.

Another issue is that some of the particular standards (device specific) were even slower. Where the particular is the "old" version, based on the 2nd edition, then technically the "old" IEC 60601-1:1988/A2:1995 still applies.

Even to this day, some of them have not been updated in Europe. For example, IEC 60601-2-25:2012 for diagnostic ECGs was never listed as harmonised, and the previous version IEC 60601-2-25:1994/A1:1999 remains the official standard, so the old IEC 60601-1 still applies.

Another example if for humidifiers, for example, ISO 8185 has only "recently" been updated to ISO 80601-2-74:2017 and is still finding it's way into regulations. If the regulation refers to ISO 8185, then the old IEC 60601-1 applies.

At some point, test agencies kind of ignored this and forced all applicants to switch to the 3rd edition anyway, my guess is this started around 2015. So it's probably that date that marked the final end to the use of the 1988 edition. Again, this is for convenience, strictly speaking it still lives on while ever the particular standard are yet to adopted in regulations.

For anyone who is in the know ... any updates on why Europe has been so slow to adopt some of the particulars? Is it just manpower or are there objections to the standard?
 
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