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ANSI/AAMI/ISO 13004:2022

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

This document describes a method for substantiating a select sterilization dose that achieves a sterility assurance level of 10-6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

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Association for the Advancement of Medical Instrumentation [aami]

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