Active , Reaffirmed Report
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AAMI/ISO TIR11137-4:2022/(R)2023

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

Summary

This technical information report 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. Annex 2

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2022
Confirmation Date 01/01/2023
Page Count 67
Themes Sterilization—Industrial
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