AAMI/ISO TIR11137-4:2022(R2023)
Current
The latest, up-to-date edition.
Sterilization of health care products—Radiation—Part 4: Guidance on process control
Hardcopy , PDF
English
09-07-2023
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.
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