NF EN ISO 11137-1

June 2026

Standard Current

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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Main informations

Collections

National standards and national normative documents

Publication date

June 2026

Number of pages

65 p.

Reference

NF EN ISO 11137-1

ICS Codes

11.080.01 Sterilization and disinfection in general

International kinship

ISO 11137-1:2025

European kinship

EN ISO 11137-1:2026

Replaced standards (2)

NF EN ISO 11137-1

January 2016

Standard Cancelled

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Le présent document spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine d''un procédé de stérilisation par irradiation pour les dispositifs médicaux.

NF EN ISO 11137-1/A2

January 2020

Standard Cancelled

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2

Le présent amendement modifie les paragraphes 4.3.4 et 11.2 de la norme NF EN ISO 11137-1:2015.

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