NF EN ISO 11137-3
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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Main informations

Collections

National standards and national normative documents

Publication date

July 2017

Number of pages

55 p.

Reference

NF EN ISO 11137-3

ICS Codes

11.080.01   Sterilization and disinfection in general

Print number

1

International kinship

ISO 11137-3:2017

European kinship

EN ISO 11137-3:2017
Sumary
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.
Replaced standards (1)
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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