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EN 12006-1 : 1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

01-12-2005

Published date

12-01-2013

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 valves
Annex B (informative) Physical and material properties
                      of heart valve substitutes and
                      their components
Annex C (informative) Standards that may be applicable
                      for testing materials and
                      components of heart valve
                      substitutes
Annex D (informative) Test apparatus for mechanical
                      testing
Annex E (normative) Test apparatus for hydrodynamic
                    testing
Annex F (informative) Rationales for pre-clinical: and
                      clinical evaluations
Annex G (informative) Concordance table EN 12006-1 and
                      ISO 5840
Annex ZA (informative) Clauses of this European Standard
                       addressing essential requirements
                       or other provisions of
                       EU Directives

Defines requirements for heart valve substitutes, excluding heart valve substitutes composed in whole, or in part, of human tissue. Supplied with consideration to safety, requirements for intended design attributes, performance, design evaluation, materials, manufacturing, sterilization, packaging and information supplied by the manufacturer. Defines a number of requirements and test procedures with respect to performance characteristics of equipment which is used to determine the chemical, biological and physical properties of heart valve substitutes and of materials and components from which they are made.

Committee
TC 285
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Superseded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

ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)

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