Radiation Die Sterilization

Radiation die sterilization is either gamma or e-beam. This is a low temperature process that does not require a breathable package. Radiation does have a potential effect on the die material selected – i.e. discoloration and/or embrittlement.

Our FDA-registered, ISO 13485 certified laboratories will validate the selected sterilization process to the current FDA and industry recognized standards: either gamma or e-beam.

AAMI/ANSI/ISO 11137-1:2006. “Sterilization of health care products – Radiation – Requirements for the development, validation and routine control of a die sterilization process for medical devices.”

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