EN ISO 14971:2019 does not include the Annex Zs

#1
The company I work for currently adheres to ISO 14971:2012. We have purchased the 2019 version and now (since we sell product to the EU) the EN 2019 version released in December. However, the EN 2019 at this time, does not include the Annex Zs. The National Foreword does state that the standard "does not contain Annex Z's" and will be updated with an amendment once finalized. If the EN 2019 version supersedes the EN ISO 14971:2012, as noted in the European Foreword, there are no Annex Z's to adhere to.

Are we just in limbo until amendments are approved? Why the intermediary release?
 
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yodon

Staff member
Super Moderator
#2
Timing! BSI just published a paper on this. Sounds like limbo, indeed. I wonder if the standards writers (including those working on harmonization) realize the economic impact on companies for these things?
 
#3
Timing! BSI just published a paper on this. Sounds like limbo, indeed. I wonder if the standards writers (including those working on harmonization) realize the economic impact on companies for these things?
Thank you for the link to that paper. Now I just need to explain to Accounting as to why I need to purchase this standard again once the Annexes are released :cautious:
 

Pads38

Trusted Information Resource
#4
Now I just need to explain to Accounting as to why I need to purchase this standard again once the Annexes are released
I found a 'preview' of the 2012 version that had the complete Z annexes - so that's what I have! Danish standards institute IIRC.
 
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