NA 176

DIN Standards Committee Health Technologies

Project

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2023); German and English version FprEN ISO 11137-1:2023

Abstract

This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of DIN EN ISO 11137 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator. This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. This document does not detail specified requirements for designating a medical device as sterile, specify a quality management system for the control of all stages of production of medical devices, specify requirements for occupational safety associated with the design and operation of irradiation facilities or specify requirements for the sterilization of used or reprocessed devices.

Begin

2020-09-21

WI

00204083

Planned document number

DIN EN ISO 11137-1

Project number

06302053

Responsible national committee

NA 176-03-09 AA - Sterilization and processing of medical devices  

Responsible european committee

CEN/TC 204 - Sterilization of medical devices  

Responsible international committee

ISO/TC 198/WG 2 - Radiation sterilization  

draft standard

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023
2023-05
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previous edition(s)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019
2020-04

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Contact

Dipl.-Phys.

Jenny Blum

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2034
Fax: +49 30 2601-42034

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