BS EN ISO 14971:2012, “Medical devices. Application of risk management to medical devices,” has been released and is now available from Document Center Inc. It is the UK implementation of EN ISO 14971:2012. It is identical to ISO 14971:2007 (Corrected Version from 10/2007). FYI: The 2012 Edition supersedes BS EN ISO 14971:2009 which is withdrawn.
This new edition provides the user with important new information on the differences between the ISO 14971 and the requirements of the 93/42/eec, 90/385/eec and 98/79/ec Directives. In other words, Annexes ZA, ZB and ZC explain to which requirements, under which conditions and to what extent presumption of conformity can be claimed.
This is the first time that I recall seeing such a clear and detailed explanation of differences between the standard and the directive in the EN Annexes that are now appearing at the head of many of the ISO adoptions. Here, for each directive referenced by Annex, there are about 7 areas with differing requirements. Furthermore, information on corrective action is also given.
Here is an example of the new guidance provided:
“1. Treatment of negligible risks:
a) According to standard ISO 14971, the manufacturer may discard negligible risks.
b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device.
c) Accordingly, the manufacturer must take all risks into account when assessing Sections 1 and 2 of Annex I to Directive 93/42/EEC.”
As you can see, this material is essential to conformance with the EN requirements and will make the purchase of the EN edition (BS EN ISO 14971 is the official English language edition) mandatory for medical device manufacturers certifying to the standard for sales in Europe.
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