Updates to EN 62366 & ISO 14971?

Mark Meer

Trusted Information Resource
#1
Hi Everyone!
I recently got an email notifying me of some upcoming changes/edits to the EN 62366 and ISO 14971 standards:

EN 62366-1:2015
The email said there is a corrigendum (EN 62366-1:2015/AC:2018), but I've been unable to find any further information. Closest thing I could find is a 2016 corrigendum which, as far as I'm aware, is just some minor corrections to references. ...could this just be a typo? ...or is there indeed a recent corrigendum?

EN ISO 14971:2012
The email said that there is a new draft. Is this standard being updated in the near future? If so, any insight into what changes/additions we might expect?

Insights much appreciated!
MM
 
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Mark Meer

Trusted Information Resource
#3
You can dl the public review AAMI-ISO CDV-1 14971 Ed.3 here: https://standards.aami.org/higherlogic/ws/public/download/14657/AAMI%20public%20review%20document%20FINAL.pdf

I haven't received any notification on 62366 and checked IEC and Cenelec and no news there. So not sure what that's all about but thanks for informing and I'll keep an eye out.
Thanks for the link craiglab, I'll have to take some time to review...

At a glance (looking at Annex B), the notable differences appear to be the addition of a few definitions, elaboration of production & post-production information, and the removal of most of the guidance annexes (apparently they are being moved to ISO/TR 24971). Are there any major (impactful) changes I should pay particular attention to?

With respect to 62366, I'm pretty certain it was a typo, and is just referring to the 2016 corrigendum... but I too will keep an eye out. ;)
 
#4
In drafting the upcoming version of 14971 some of the content has been moved to the companion guidance standard 24971. Several of the 'informative' annexes have been moved, so it will effectively need to be used alongside the new 14971.

Marcelo (who is on the committee) is posting progress reports here:

ISO 14971 and ISO TR 24971 revision
 
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