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ISO/TS 11137-4:2020

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

General information

Valid from 30.06.2020
Directives or regulations
None

Standard history

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Date
Type
Name
30.06.2020
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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