Is it essential to do the Fractional Test for ETO Revalidation?

M

Monna89

#1
Hello to all,

Recently I have received a draft protocol for revalidation test(according to ISO 11135) for our product. I compared that with the one that had done 2 years ago.
All the parts was the same except the part related to fractional test. They will do half cycle, Full cycle and not fractional test.
I do not know what rational behind that to take off the fractional test.
Can you please help me about this issue?
According to which standard we can or can not remove the fractional test?
 
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v9991

Trusted Information Resource
#2
I am not experienced/exposure to ETO-revalidation:eek:, yet an interpretation of guideline is what I am trying to state here...:agree:

it could depend on reason for re-validation...
fractional test could be used/relied upon viz., for

 
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