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DS ISO/TS 11137-4:2020

Sterilization of health care products — Radiation — Part 4: Guidance on process control

Aug 23, 2022

General information

60.60     Aug 23, 2022

DPS

DPS/KT 205

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 ISO/TS 11137-4:2020
60.60 Standard published
Aug 23, 2022

Related project

Adopted from ISO/TS 11137-4:2020