Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
6.1 Intended use
6.2 Design inputs
6.2.1 Operational specifications
6.2.2 Performance specifications
6.2.3 Packaging, labelling, and sterilization
6.3 Design outputs
6.3.1 General
6.3.2 Examples of components of some heart valve substitutes
6.4 Design transfer (manufacturing qualification)
6.5 Risk management
6.5.1 Hazard identification
6.5.2 Failure mode identification
6.5.3 Risk estimation
6.5.4 Risk evaluation
6.5.5 Risk control
6.6.6 Risk review
7 Verification testing and analysis/Design validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 Test conditions, sample selection and reporting
requirements
7.2.2 Material property assessment
7.2.3 Hydrodynamic performance assessment
7.2.4 Structural performance assessment
7.3 Preclinical in vivo evaluation
7.3.1 Overall requirements
7.3.2 Methods
7.3.3 Test report
7.4 Clinical investigation
7.4.1 Clinical investigation
7.4.2 General
7.4.3 Number of institutions
7.4.4 Number of patients
7.4.5 Duration of study
7.4.6 Clinical data requirements
7.4.7 Clinical investigation report
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
Annex ZA (informative) Relationship between this International
Standard and the Essential Requirements of EU Directive
93/42
Bibliography