Glossary of equivalent standards
Committee representation
Background on AAMI adoption of ISO 5840:2005
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, labeling, 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
6.5.6 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 Principle
7.4.2 General
7.4.3 Number of institutions
7.4.4 Number of patients
7.4.5 Duration of the study
7.4.6 Clinical data requirements
7.4.7 Clinical investigation report
Annexes
A Rationale for the provisions of this International
Standard
B Heart valve substitute hazards, associated failure
modes, and evaluation methods
C Risk assessment guidelines
D Examples and definitions of some physical and material
properties of heart valve substitutes and their components
E Statistical procedures when using performance criteria
F In vitro procedures for testing unstented or similar
valves in compliant chambers
G Preclinical in vivo tests
H Echocardiographic protocol
I Description of the heart valve substitute
J Figures of examples of components of some heart valve
substitutes
K Examples of standards applicable to testing of materials
and components of some heart valve substitutes
L Guidelines for verification of hydrodynamic performance
M Durability testing
N Examples of design specific testing
O Fatigue assessment
P Packaging
Q Labeling and instructions for use
R Methods of evaluating clinical data
S Sterilization
Bibliography