What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments?

Mark Meer

Trusted Information Resource
#1
I noticed in the "Work in Progress" tab under the IEC 60601-1 page from the IEC Webstore, that a new amendment (AMD2) was forcast to be published last week.

Similarly, the IEC 60601-1-2 standard is forecast to have an amendment (AMD1) next month (Sept.2020).

Anyone know what to anticipate in these amendments?
We are currently scheduling some 60601 testing, and it would be very annoying to miss out on requirements of new amendments released at the same time that we are testing...
 
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Jim Wynne

Staff member
Admin
#5
I noticed in the "Work in Progress" tab under the IEC 60601-1 page from the IEC Webstore, that a new amendment (AMD2) was forcast to be published last week.

Similarly, the IEC 60601-1-2 standard is forecast to have an amendment (AMD1) next month (Sept.2020).

Anyone know what to anticipate in these amendments?
We are currently scheduling some 60601 testing, and it would be very annoying to miss out on requirements of new amendments released at the same time that we are testing...
There could be some help for you here.
 

Tidge

Quite Involved in Discussions
#7
We are currently scheduling some 60601 testing, and it would be very annoying to miss out on requirements of new amendments released at the same time that we are testing...
In the past, the transition periods for 60601-x updates have been significantly long enough that unless a development team is leveraging 60601-1 testing to assist with the (safety features of) design itself, the development should be ok. What I describe is not an uncommon practice, but waiting to implement a 60601-1 safety feature until discovered by a NRTL is not a good practice IMO. Writing that, I would expect that a NRTL would be keyed into the approved updates and should be able to assist.

Thanks to @Jim Wynne for posting the link. I haven't done an extremely deep read, but my initial reactions are in the area of the 'laptop power supply' rule (I was ignorant of this issue, it seems straightforward) and indicator signals/alarm signals.

I'm slightly concerned that the article (as written, as read by me) appears to be minimizing the idea that there could also be an alarm condition that arises from a technical issue... as opposed to the specific physiological condition of a patient. In my experience, the physiological alarm conditions are best analyzed for devices which specifically monitor physiological parameters (per the intended Use). Many potential physiological harms can arise from devices which do absolutely no physiological monitoring; I would not expect design/development/description/analysis of 'physiological alarms' for such devices. In my experience the tie between a technical alarm condition to a 'physiological harm' is done through the Hazard Analysis, but I have not treated these as physiological alarm conditions. If the standards are being updated to make a change like this explicit, I will have to adjust my thinking.

The article's discussion around symbols aligns with my own understanding. It also appears that the discussion of 'optical radiation' is continuing the trend of correcting the initially published (semi-)equating of lasers and light-emitting diodes in 60601-1 (3rd).
 

Mark Meer

Trusted Information Resource
#8
In the past, the transition periods for 60601-x updates have been significantly long enough that unless a development team is leveraging 60601-1 testing to assist with the (safety features of) design itself, the development should be ok. What I describe is not an uncommon practice, but waiting to implement a 60601-1 safety feature until discovered by a NRTL is not a good practice IMO. Writing that, I would expect that a NRTL would be keyed into the approved updates and should be able to assist.....
My concern is both with future-proofing both design (e.g. if new condition or labeling symbol is required in AMD2 of 60601-1), and EMC (e.g. if there are new/stricter test levels in AMD1 of 60601-1-2).
I understand that there are fairly long transition periods, but if, for example, we could test to some higher EMC criteria now in anticipation of AMD1 changes, and avoid us having to consider re-testing 3 years from now (or whatever the transition period), that'd be ideal.
 
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