NBN 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
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).
| DevelopmentNote |
1998 Edition Re-issued in August 2009 & incorporates AMD 1 2009. (09/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN 12006-2 : 2009 | Identical |
| 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 |
| SN EN 12006-2 : 1998 + A1 2009 | Identical |
| UNE-EN 12006-2:1998 | Identical |
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