EN 12006-1 : 1999

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.