nsBAS CEN ISO/TS 11137-4:2024
Sterilization of health care products - Radiation - Part 4: Guidance on process control
General information
Status:Project
Number of pages:62
Adoption method:Proglašavanje
Language:engleski
Edition:1.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
ICS:
11.080.01, Sterilization and disinfection in general
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
Work material
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