NF EN 12006-3 : 1999 + A1 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES
01-02-2012
12-01-2013
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Définitions
4 Performances prévues
5 Attributs de conception
6 Matériaux
7 Évaluation de la conception
8 Fabrication
9 Stérilisation
10 Emballage
11 Informations fournies par le fabricant
Annexe A (informative) Bibliographie
Annexe B (informative) Études animales sur des endoprothèses
Annexe ZA (informative) Relation entre la présente Norme
européenne et les exigences essentielles de la
Directive UE 93/42/CEE
Details particular requirements for endovascular devices. With reference to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. Vascular occluders are not in this standard.
| DevelopmentNote |
Indice de classement: S94-201-3. 1999 Edition Re-issued in July 2009 & incorporates AMD 1 2009. (07/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| UNE-EN 12006-3:1999 | Identical |
| DIN EN 12006-3:1999-01 | Identical |
| DIN EN 12006-3:2009-08 | Identical |
| UNI EN 12006-3 : 2009 | Identical |
| BS EN 12006-3 : 1999 | Identical |
| EN 12006-3:1998+A1:2009 | Identical |
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