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

ISO-11137-4 - 1ST EDITION - CURRENT


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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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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO/TS 11137-4:2020

Revision Level

1ST EDITION

Status

Current

Publication Date

June 1, 2020

Committee Number

ISO/TC 198