NF EN ISO 11137-1

Afnor EDITIONS
Standards
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.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2006

Number of pages

51 p.

Reference

NF EN ISO 11137-1

ICS Codes

11.080.01 Sterilization and disinfection in general

International kinship

ISO 11137-1:2006

European kinship

EN ISO 11137-1:2006

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 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.

Replaced standards (2)

NF EN 552/A1

January 1999

Standard Cancelled

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Le présent document modifie les annexes A et B.

NF EN 552/A2

February 2001

Standard Cancelled

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Le présent document modifie le paragraphe 4.2.1 b), pour résoudre les différences dans l'interprétation des prescriptions techniques concernant l'établissement de la dose stérilisante.

Standard replaced by (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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