NF EN 552 : 94 AMD 2 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
23-07-2013
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Superseded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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