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AAMI/ISO TIR11137-4:2022

Sterilization of health care products - Radiation - Part 4: Guidance on process control

This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.


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Association for the Advancement of Medical Instrumentation [AAMI]


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