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EN 12006-2:1998+A1:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

01-03-2017

Published date

06-05-2009

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 (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

This standard describes 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.This European Standard is not applicable to prostheses derived from host tissue (autografts).NOTEA valve conduit is regarded as a composite prosthesis and falls within the scope of this standard.With regard to safety it gives in addition to EN ISO 14630:1997, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.This European Standard specifies the designation of materials of the manufacturer and the construction of the device, and the designation of sizes and dimensions of vascular prostheses. It specifies biological requirements for the materials of construction and for the finished product by references to appropriate International and European Standards.In addition this European Standard specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties stated by the manufacturer, including durability testing.This standard also gives requirements for packaging and labelling. It provides definitions of the terms in common use.This European Standard does not specify all possible performance or dimensional characteristics. In such cases, the European Standard does however include methods to verify the nominal values stated by the manufacturer.

Committee
CEN/TC 285
DevelopmentNote
1998 Edition Re-Issued in May 2009 & incorporates AMD 1 2009. (06/2009) To be read in conjunction with EN ISO 14630. (12/2009)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
BS EN ISO 14630:2012 Non-active surgical implants. General requirements
BS EN 14299:2004 Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents
I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
DIN EN 14299:2004-08 NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
I.S. EN 14299:2004 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
01/564791 DC : DRAFT NOV 2001 BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
EN 14299 : 2004 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
ISO 14630:2012 Non-active surgical implants — General requirements

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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