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DS CEN ISO/TS 11137-4:2023

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

Dec 19, 2025

General information

60.60     Dec 19, 2025

95.99   

DPS

DPS/KT 316

Technical Specification

11.080.01  

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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.

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PUBLISHED
DS CEN ISO/TS 11137-4:2023
60.60 Standard published
Dec 19, 2025

Related project

Adopted from CEN ISO/TS 11137-4:2023 IDENTICAL

Adopted from ISO/TS 11137-4:2020 IDENTICAL