Shipping Validation of Non-Sterile Parts?

Ramya

Starting to get Involved
Hi Folks,

Is ISTA 3A accepted under EU MDR in place of ASTM D4169 for transportation testing?
 

planB

Super Moderator
Is ISTA 3A accepted under EU MDR in place of ASTM D4169 for transportation testing?

To my knowledge - yes, as long as your product shipping configuration and your mode(s) of distribution are covered by the ISTA test sequence.
 
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