IEC 60601-1 3rd ed vs. IEC 60601-1 2nd ed Gap Analysis

N

noen98

#1
Hi All,

For some reason I need to perform a gap analysis of the 60601-1 for 2nd to 3rd edition. Due to the enormous changes in the two edition I am struggle to do so. Is there a ready template or any guidance how to perform the gap?

thanks in advance
 
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N

noen98

#2
I did some reach again on this forum and found a link to the TR which helps alot.

Can't post the link due to low post count

but not in great details for gap
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
:topic: You can put in a link if you leave off the http:// prefix. A moderator or I will activate the link when your post is reviewed as most posts are. We have this limitation to keep spam out of the forum. I apologise for the inconvenience.
 

Peter Selvey

Staff member
Moderator
#5
That TR is useful for finding requirements, but not for a gap analysis, because it does not show if the requirements are equivalent or changed.

Because of the many changes, a simple gap analysis is not practical. Rather an upgrade approach is best. This method uses a complete clause list for the 3rd edition (e.g. IECEE CB scheme TRF), with around 1400 line items to check (don't worry, many will be not applicable for a particular device). But, it's still a gap analysis: instead of re-testing everything, you can transfer or refer to the test data in the old report(s) if it fits the new standard, which is often the case.

From experience it usually takes about 2 days to complete the clauselist, after which you should have the "gap" results:

- list of required tests (e.g. new tests in the 3rd ed),
- new documents required (e.g. risk management file)
- non-conformities (design mods necessary to fit the new standard, usually limited to the instruction manual)
 

Marcelo

Inactive Registered Visitor
#6
That TR is useful for finding requirements, but not for a gap analysis, because it does not show if the requirements are equivalent or changed.
Curiously, it has been proposed very recently (last week :)) that IEC TR 62348 be changed to assess the impact of the changes of Amendment 1 in relation to IEC 60601-1:2005. This way the TR will be more useful (and it´s a shame that the same thing was not thought between 2nd and 3rd edition).
 
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