Medical Device Electrical Safety Standards - Gap Analysis of Latest Revisions


Starting to get Involved
Hi all,

I am trying to do a gap analysis for the following standards to understand if we need to redo some of the testings, and if not to document the rational:

EN 60601-1:2006 – new standard is EN 60601-1:2006+A12:2014
EN 60601-1-11:2010 – new standard is EN 60601-1-11:2015
EN 60601-1-2:2007 – new standard is EN 60601-1-2:2015
IEC 62133:2012 – new standard is IEC 62133-1:2017

Is anyone done that before?



Re: Medical Electrical Safety Standards -Gap analysis

Hi Alex,
I have not done a gap analysis specific to those standards but I have for many others. Usually what I do is put the new text into a table, compare the new revision vs the old revision and highlight the new text green and incorporate the deleted text in red font. Than i would determine if there is a impact to product/process.

Its very tedious but its what works for us:)



  • gap assessment example.docx
    97 KB · Views: 377


Starting to get Involved
Thanks Ryan,

I don't have those standards yet, hopped maybe someone knows the answers. :) So I don't have to buy those standards....

Top Bottom