NF EN ISO 11137-1
NF EN ISO 11137-1

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.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2016

Release date

août 2026

Number of pages

59 p.

Reference

NF EN ISO 11137-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Print number

1

International kinship

ISO 11137-1:2006

European kinship

EN ISO 11137-1:2015
Sumary
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.
Replaced standards (1)
NF EN ISO 11137-1
NF EN ISO 11137-1
July 2006
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 radiation pour les dispositifs médicaux. Il couvre les procédés de radiation utilisant des irradiateurs, qui emploient les radionucléides 60Co ou 137Cs, un faisceau à partir d''un générateur d''électrons, ou un faisceau à partir d''un générateur de rayons X.

Standard replaced by (1)
NF EN ISO 11137-1
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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