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Technische Regel

ISO/TS 11137-4:2020

Issue date: 2020 06 30

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

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 establi...
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Publisher:
International Organization for Standardization
Format:
Digital | 55 Pages
Language:
English

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.