IEC 80001 and ISO 14971 Comparison

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Marcelo

Inactive Registered Visitor
#4
You can think of it this way - IEC 80001 is an extension of the medical device risk management process defined by ISO 14971 to be performed by the anufacturer, but it´s a part which has to be performed at the user site (for example, hospital network) to guarantee that the use of a product is not made more riski due to the network. It also involves other parties such as the network provider.

The process of IEC 80001 was obviously based on ISO 14971 but a direct comparison cannot be really made.
 
W

Wirelessbitz

#5
There is actually a table in the appendix (table A.1) that shows the relationship between 80001-1 and 14971 because this was a brought up in the commenting period (it was started in one of the TRs but moved to the main document). Additionally, in the main body there are clear references made to 14971 where verbage was 'cut and pasted' or modified for 80001-1. So yes, there is a strong corollary between the two standards.

The standard is available (AAMI has good price for members). As pointed out, the TRs are in process (comment period).
 
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