NF EN 552
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.

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Collections

National standards and national normative documents

Publication date

January 1994

Release date

juin 2006

Number of pages

34 p.

Reference

NF EN 552

ICS Codes

11.080.01   Sterilization and disinfection in general

European kinship

EN 552:1994
Sumary
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.
Standard replaced by (2)
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.

NF EN ISO 11137-2
January 2006
Standard Cancelled
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Le présent document spécifie des méthodes de détermination de la dose minimale nécessaire pour atteindre une exigence spécifiée de stérilité et des méthodes pour justifier l''utilisation de la dose stérilisante de 25 kGy ou de la dose stérilisante de 15 kGy pour obtenir un niveau d''assurance de la stérilité de 10 puissances-6. Cette norme spécifie aussi des méthodes d''audit de la dose pour démontrer l''efficacité continue de la dose stérilisante.

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