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CEN ISO/TS 11137-4:2023

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

General information
Valid from 03.07.2023
Base Documents
ISO/TS 11137-4:2020; CEN ISO/TS 11137-4:2023
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.07.2023
Main
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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