UNE-EN 12006-2:1998
Withdrawn
NON-ACTIVE SURGICAL IMPLANTS. PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS. PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS.
Hardcopy , PDF
Spanish, Castilian
11-24-1998
03-22-2010
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (normative) Classification of prostheses
Annex B (normative) Bibliography
Annex C (informative) Reference table EN 12006-2 and
ISO/DIS 7198
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives
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).
| Committee |
CTN 91
|
| DevelopmentNote |
1998 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (09/2009)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DIN EN 12006-2:1998-05 | Equivalent |
| NEN EN 12006-2 : 1998 + A1 2009 | Identical |
| NBN EN 12006-2 : 1998 + A1 2009 | Identical |
| EN 12006-2:1998+A1:2009 | Identical |
| I.S. EN 12006-2:1998 | Identical |
| BS EN 12006-2 : 1998 | Identical |
| DIN EN 12006-2:2009-08 | Identical |
| NF EN 12006-2 : 1998 + A1 2009 | Identical |
| NS EN 12006-2 : 1998 + A1 2009 | Identical |
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