Historical
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.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]