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NF EN 552 : 94 AMD 2 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION

Superseded date

23-07-2013

Published date

12-01-2013

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Définitions
4 Généralités
5 Validation
6 Controle et surveillance du procédé
7 Libération du produit après stérilisation (libération
  paramétrique)
Annexe A (informative) Guide relatif a l'application de
                       l'EN 552
Annexe B (informative) Bibliographie

Gives requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. Specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. Does not cover radiation protection requirements associated with operating irradiation plants.

DevelopmentNote
Indice de Classement: S98-103. (04/2002)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded

Standards Relationship
DIN EN 552:1994-11 Identical
DIN EN 552:2001-02 Identical
EN 552:1994/A2:2000 Identical
I.S. EN 552:1994 Identical

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