AAMI ANSI/AAMI/ISO 13004:2022

Current Revision
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmax SD

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AAMI ANSI/AAMI/ISO 13004:2022

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmax SD

PUBLISH DATE 2024
AAMI ANSI/AAMI/ISO 13004:2022
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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