NF EN ISO 11137-3
NF EN ISO 11137-3

NF EN ISO 11137-3

October 2006
Standard Cancelled

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

Le présent document sert de guide pour l''interprétation des exigences relatives à la dosimétrie et aux mesures de dose spécifiées dans les normes ISO 11137 parties 1 et 2. Il s''applique aux irradiateurs gamma utilisant des radionucléides 60Co et 137Cs ainsi qu''aux irradiateurs utilisant un générateur gamma ou de rayons X.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2006

Number of pages

29 p.

Reference

NF EN ISO 11137-3

ICS Codes

11.080.01   Sterilization and disinfection in general

International kinship

ISO 11137-3:2006

European kinship

EN ISO 11137-3:2006
Sumary
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

Le présent document sert de guide pour l''interprétation des exigences relatives à la dosimétrie et aux mesures de dose spécifiées dans les normes ISO 11137 parties 1 et 2. Il s''applique aux irradiateurs gamma utilisant des radionucléides 60Co et 137Cs ainsi qu''aux irradiateurs utilisant un générateur gamma ou de rayons X.
Replaced standards (3)
NF EN 552
NF EN 552
January 1994
Standard Cancelled
Sterilization of medical devices. Validation and routine control of sterilization by irradiation.

Ce document spécifie les exigences concernant la validation, la maîtrise du procédé et la surveillance de lastérilisation des dispositifs médicaux par irradiation.

NF EN 552/A1
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
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 11137-3
NF EN ISO 11137-3
July 2017
Standard Current
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

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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