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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)

Publication date:   Oct 16, 2023

General information

60.60 Standard published   Jun 21, 2023

CEN

CEN/TC 204 Sterilization of medical devices

Technical Specification

11.080.01   Sterilization and disinfection in general

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Scope

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.

Life cycle

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PUBLISHED
CEN ISO/TS 11137-4:2023
60.60 Standard published
Jun 21, 2023

Relations

Adopted from ISO/TS 11137-4:2020 IDENTICAL