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NF EN 12442-1 : 2000

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK

Superseded date

03-01-2008

Published date

01-12-2013

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Mode opératoire
5 Exigences concernant la gestion des risques
6 Revue de l'analyse du risque
Annexe A (informative) - Représentation graphique du processus
         de gestion des risques
Annexe B (informative) - Lignes directrices concernant
         l'application de la présente partie de l'EN 12442
Annexe C (informative) - Applicabilité des annexes informatives
         de l'EN 1441
Annexe D (informative) - Analyse et gestion des risques liés aux
         agents transmissibles
Annexe ZA (informative) - Articles de la présente norme européenne
          concernant les exigences essentielles ou d'autres
          dispositions des Directives UE
Bibliographie

Applicable to medical devices (excluding in-vitro diagnostic medical devices) made using animal tissue or products derived from animal tissue which are or have been rendered non-viable. Specifies a procedure to investigate, using available information the safety of such devices by identifying hazards and estimating risks associated with the device (risk analysis).

DevelopmentNote
Indice de classement: S97-601-1 Supersedes NFS 97 601-1 (03/2004)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded
Supersedes

Standards Relationship
DIN EN 12442-1:1998-05 (Draft) Identical
DIN EN 12442-1:2001-01 Identical
BS EN 12442-1:2000 Identical
EN 12442-1 : 2000 Identical
UNE-EN 12442-1:2001 Identical
I.S. EN 12442-1:2000 Identical

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