AAMI/ISO TIR11137-4:2022
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Sterilization of health care products—Radiation—Part 4: Guidance on process control
Hardcopy , PDF
12-07-2023
English
01-25-2022
This document provides additional guidance to that given in the International Organization for Standardization (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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