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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