NF EN 12006-2 : 1998 + A1 2009
Current
The latest, up-to-date edition.
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
12-01-2013
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Définitions
4 Performances prévues
5 Conception
6 Matériaux
7 Évaluation de la conception
8 Fabrication
9 Stérilisation
10 Emballage
11 Informations fournies par le fabricant
Annexe A (normative) Classification des prothèses
Annexe B (informative) Bibliographie
Annexe C (informative) Table de concordance entre
l'EN 12006-2 et l'ISO/DIS 7198
Annexe ZA (informative) Relation entre la présente Norme
européenne et les exigences essentielles de la
Directive UE 93/42/CEE
Covers specified requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, reconstruct, bypass or form shunts between segments of the cardio-vascular system in humans. Does not apply to prostheses derived from host tissue (autografts).
| DevelopmentNote |
Indice de classement: S94-201-2. 1998 Edition Re-issued in July 2009 & incorporates AMD 1 2009. (07/2009)
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| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
|
| Standards | Relationship |
| EN 12006-2:1998+A1:2009 | Identical |
| I.S. EN 12006-2:1998 | Identical |
| DIN EN 12006-2:2009-08 | Identical |
| BS EN 12006-2 : 1998 | Identical |
| UNE-EN 12006-2:1998 | Identical |