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BS EN ISO 5840-2:2015

BS EN ISO 5840-2:2015

$198.66

Cardiovascular implants. Cardiac valve prostheses – Surgically implanted heart valve substitutes

Published By Publication Date Number of Pages
BSI 2015 66
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PDF Pages PDF Title
4 European foreword
5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices
8 Foreword
9 Introduction
10 1 Scope
2 Normative references
11 3 Terms and definitions
13 4 Abbreviations
5 Fundamental requirements
14 6 Device description
6.1 Intended use
6.2 Design inputs
6.2.1 Operational specifications
6.2.2 Performance specifications
15 6.2.3 Packaging, labelling, and sterilization
6.3 Design outputs
6.3.1 General
6.4 Design transfer (manufacturing qualification)
6.5 Risk management
7 Design verification testing and analysis/design validation
7.1 General requirements
16 7.2 In vitro assessment
7.2.1 Test conditions, sample selection, and reporting requirements
17 7.2.2 Material property assessment
7.2.3 Hydrodynamic performance assessment
19 7.2.4 Structural performance assessment
20 7.2.5 Device MRI safety
7.2.6 Additional implant design evaluation requirements
21 7.2.7 Design specific testing
7.2.8 Simulated use
7.2.9 Human factors/usability assessment
7.3 Preclinical in vivo evaluation
7.3.1 Overall requirements
22 7.3.2 Methods
23 7.3.3 Test report
24 7.4 Clinical investigation
7.4.1 General
7.4.2 Statistical considerations
7.4.3 Distribution of subjects and investigators
7.4.4 Sample size
25 7.4.5 Entry criteria
7.4.6 Duration of the study
7.4.7 Clinical data requirements
27 7.4.8 Clinical investigation report
29 Annex A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods
32 Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers
34 Annex C (informative) Preclinical in vivo evaluation
37 Annex D (informative) Description of the surgical heart valve substitute
39 Annex E (informative) Examples of components of some surgical heart valve substitutes
43 Annex F (informative) Guidelines for verification of hydrodynamic performance
52 Annex G (informative) Durability testing
54 Annex H (informative) Examples of design specific testing
56 Annex I (informative) Fatigue assessment
62 Annex J (normative) Methods of evaluating clinical data
63 Bibliography

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BS EN ISO 5840-2:2015
$198.66