NEN EN 12006-2 : 1998 + 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
03-09-2017
01-12-2013
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
Defines specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.
| DevelopmentNote |
1998 Edition Re-Issued in May 2009 & incorporates AMD 1 2009. (05/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Superseded
|
| 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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