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UNI EN 12006-2 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Superseded date

19-10-2017

Published date

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Superseded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

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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