Project

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024

Abstract

This document specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications. This document does not specify requirements for the 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. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. This document does not detail a specified requirement for designating a medical device as sterile. This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. This document does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber. This document does not cover analytical methods for determining levels of residual EO and/or its reaction products.

Begin

2020-07-29

WI

00204081

Planned document number

DIN EN ISO 11135

Project number

06302046

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 1 - Industrial ethylene oxide sterilization  

draft standard

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023
2023-05
Order from Beuth Verlag

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
2024-04
Order from Beuth Verlag

previous edition(s)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
2020-04

Order from Beuth Verlag

Contact

M.Sc.

Maximilian Rasser

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2572
Fax: +49 30 2601-42572

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