What are the new changes in EN ISO 11137-1:2015+A2:2019?

Ramanaik

Starting to get Involved
#1
Hi,

Please tell any one;


what is the new changes in EN ISO 11137-1:2015+A2:2019, is it need to perform ETO validation again for medical device, which was per performed under previous version of guideline. or only gap analysis is enough to submit for MDR approval.


Thank you in advance
 
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planB

Super Moderator
#2
Ramanaik,

EN ISO 11135:2014 + A1:2019 is the standard for ETO sterilization; EN ISO 11137-1:2015 + A2:2019 ist the standard for _radiation_ sterilization.

You may want to perform a gap analysis in any case. Typically, amendments denoted with A1, A2, etc., are corrections and clarifications that do not contain significant changed technical requirements warranting re-validation; for major standard revisions, this might be different.

HTH,
 
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