I.S. EN 12006-2:1998
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
Hardcopy , PDF
31-03-2020
English
01-01-1998
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
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 July 2009 & incorporates AMD 1 2009. (07/2009)
|
| DocumentType |
Standard
|
| Pages |
15
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy |
| 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 |
| DIN EN 12006-2:2009-08 | Identical |
| NS EN 12006-2 : 1998 + A1 2009 | Identical |
| UNI EN 12006-2 : 2009 | Identical |
| SN EN 12006-2 : 1998 + A1 2009 | Identical |
| UNE-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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