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ISO/TS 11137-4:2020

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

Publication date:   Jun 30, 2020

General information

90.93 Standard confirmed   Feb 16, 2024

ISO

ISO/TC 198 Sterilization of health care products

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

NOW

PUBLISHED
ISO/TS 11137-4:2020
90.93 Standard confirmed
Feb 16, 2024