Defining Expected Service Life in Risk Management File

[akp060]

The Risk Management File has different forms like the Risk Analysis, Risk Management Report, etc.. Can someone please help in identifying the document in which Expected Service Life should be mentioned and in what way (s).

 

[John Broomfield]

We normally think about expected service life when evaluating design inputs:

design input: Expected Service Life site:elsmar.com at DuckDuckGo

Accordingly, this DuckDuckGo search of the Cove may help.

 

[akp060]

Hello John,
Thank You for the reply. However, as per the standard Compliance is checked in the Risk Management File, we do not refer design inputs anywhere in the file. That leads to the confusion

 

[John Broomfield]

Which standard are you referring too?

 

[akp060]

IEC 60601-1 Ed. 3.1 2012

 

[John Broomfield]

Thanks.

You may find the answer to your question here:

Setting Expected Service Life for an an Electrical/Electronic Medical Device