Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Verification testing and analysis/Design validation
Annex A (informative) - Rationale for the provisions of
this International Standard
Annex B (informative) - Heart valve substitute hazards,
associated failure modes and
evaluation methods
Annex C (informative) - Risk assessment guidelines
Annex D (informative) - Examples and definitions of
some physical and material
properties of heart valve
substitutes and their components
Annex E (informative) - Statistical procedures when using
performance criteria
Annex F (informative) - In vitro procedures for testing
unstented or similar valves in
compliant chambers
Annex G (informative) - Preclinical in vivo tests
Annex H (informative) - Echocardiographic protocol
Annex I (informative) - Description of the heart valve
substitute
Annex J (informative) - Figures of examples of components
of some heart valve substitutes
Annex K (informative) - Examples of standards applicable
to testing of materials and components
of some heart valve substitutes
Annex L (informative) - Guidelines for verification of
hydrodynamic performance
Annex M (informative) - Durability testing
Annex N (informative) - Examples of design specific testing
Annex O (informative) - Fatigue assessment
Annex P (normative) - Packaging
Annex Q (normative) - Labelling and instructions for use
Annex R (normative) - Methods of evaluating clinical data
Annex S (normative) - Sterilization
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC