UNI EN 12006-2 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
19-10-2017
01-01-2009
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 (informative) - Bibliography
Annex C (informative) - Reference table EN 12006-2 and
ISO/DIS 7198
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Deals with 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.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN 12006-2 : 1998 + A1 2009 | Identical |
| NBN EN 12006-2 : 1998 + A1 2009 | Identical |
| BS EN 12006-2 : 1998 | Identical |
| NF EN 12006-2 : 1998 + A1 2009 | Identical |
| SN EN 12006-2 : 1998 + A1 2009 | Identical |
| UNE-EN 12006-2:1998 | Identical |
| DIN EN 12006-2:2009-08 | Identical |
| NS EN 12006-2 : 1998 + A1 2009 | Identical |
| I.S. EN 12006-2:1998 | Identical |
| EN 12006-2:1998+A1:2009 | Identical |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| EN 540 : 1993 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS |
| ISO 2960:1974 | Textiles — Determination of bursting strength and bursting distension — Diaphragm method |
| ISO 5084:1996 | Textiles — Determination of thickness of textiles and textile products |
| ISO 2076:2013 | Textiles Man-made fibres Generic names |
| ISO 2859-2:1985 | Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection |
| EN ISO 10993-7 : 2008 COR 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009) |
| ISO 5081:1977 | Textiles Woven fabrics Determination of breaking strength and elongation (Strip method) |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 472:2013 | Plastics — Vocabulary |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
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