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I.S. EN 12006-2:1998

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
Available format(s)

Hardcopy , PDF

Withdrawn date

03-31-2020

Language(s)

English

Published date

01-01-1998

Publisher

National Standards Authority of Ireland

Preview

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.

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Withdrawn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

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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Hardcopy - English
PDF - English
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