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Stability testing of medical devices as per ASTM F1980-16

BNVS

Registered
#1
Recently, we got audited for CE mark and our products are polymeric based sterile devices. During audit, auditor asks for the humidity levels for the product and as per ASTM 1980 humidity is not a mandatory requirement to be considered for testing and ASTM considers only temperature based on Arrhenius equation . My point is why do we need to consider the humidity levels when there is no requirement. Separately, we can determine the effect of humidity on the sterile packages.

Please help me whether I am correct or not
 
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