BAS CEN ISO/TS 11137-4:2024
Sterilization of health care products - Radiation - Part 4: Guidance on process control
General Information
Status: Published
No. of pages: 62
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 10.06.2024
Technical committee:
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- CEN ISO/TS 11137-4:2023, identical
- ISO/TS 11137-4:2020, identical