Sterile Product Ship Testing (Medical Device Packaging)

S

SK Vision

#1
Does anyone have a clear idea on the minimum "Ship Testing" requirements for a sterile medical device. ISO 11607-1 seems very vague.

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Materials and preformed sterile barrier systems shall be transported and stored under conditions that ensure that the performance characteristics remain within specified limits (see 5.1).


This can be accomplished by:
a) demonstrating retention of these characteristics under defined storage conditions, and
b) ensuring that storage conditions remain within specified limits.
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