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Folks
Please share experience, sources, precautions and reference to standards that should be considered when changing a Medical Device sterilization method from ETO to Gamma Sterilization.
a) Will the shelf life be affected?
b) Is new age testing required?
c) Once a first product is "converted" how to use it as "parent" for future adoptions of same dose for other devices under the same family
Thanks
Please share experience, sources, precautions and reference to standards that should be considered when changing a Medical Device sterilization method from ETO to Gamma Sterilization.
a) Will the shelf life be affected?
b) Is new age testing required?
c) Once a first product is "converted" how to use it as "parent" for future adoptions of same dose for other devices under the same family
Thanks