NF EN 12442-1 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
12-01-2013
01-03-2008
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Superseded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 |
| UNE-EN 12442-1:2001 | Identical |
| BS EN 12442-1:2000 | Identical |
| EN 12442-1 : 2000 | Identical |
| I.S. EN 12442-1:2000 | Identical |