Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137)

[CQUINT]

I am researching gamma irradiation sterilization protocols examples for a medical device based on ISO 11137 (VDmax25 option). May you share an example of the validation plan and associated protocols?

 

[chris1price]

Unfortunately, for confidentiality reasons I cant share the protocols and plan. However read through ISO11137. It walks you through the requirements in a lot of detail. That is a good place to start.