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BS EN ISO 5840-3:2021

BS EN ISO 5840-3:2021

$198.66

Cardiovascular implants. Cardiac valve prostheses – Heart valve substitutes implanted by transcatheter techniques

Published By Publication Date Number of Pages
BSI 2021 66
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This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.

This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 Abbreviations
13 5 Fundamental requirements
6 Device description
6.1 General
14 6.2 Intended use
6.3 Design inputs
6.3.1 Operational specifications
6.3.2 Performance specifications
15 6.3.3 Implant procedure
6.3.4 Packaging, labelling and sterilization
6.4 Design outputs
6.5 Design transfer (manufacturing verification/validation)
6.6 Risk management
16 7 Design verification and validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 General
7.2.2 Test conditions, sample selection and reporting requirements
7.2.3 Material property assessment
7.2.4 Hydrodynamic performance assessment
18 7.2.5 Structural performance assessment
7.2.6 Design- or procedure-specific testing
20 7.2.7 Device MRI compatibility
7.2.8 Simulated use
7.2.9 Human factors and usability assessment
7.2.10 Implant thrombogenic and haemolytic potential assessment
7.3 Preclinical in vivo evaluation
7.3.1 General
21 7.3.2 Overall requirements
22 7.3.3 Methods
23 7.3.4 Test report
24 7.4 Clinical investigations
7.4.1 General
25 7.4.2 Study considerations
26 7.4.3 Study endpoints
27 7.4.4 Ethical considerations
7.4.5 Pivotal studies: Distribution of subjects and investigators
28 7.4.6 Statistical considerations including sample size and duration
30 7.4.7 Patient selection criteria
7.4.8 Valve thrombosis prevention
31 7.4.9 Clinical data requirements
36 Annex A (informative) Description of the transcatheter heart valve system
38 Annex B (informative) Transcatheter heart valve substitute hazard analysis example
40 Annex C (informative) Guidelines for verification of hydrodynamic performance — Pulsatile flow testing
48 Annex D (normative) Requirements for delivery system design and evaluation
50 Annex E (informative) Examples of design specific testing
52 Annex F (informative) Preclinical in vivo evaluation
55 Annex G (normative) Adverse event classification during clinical investigation
61 Annex H (informative) Multimodality imaging of TAVI and TMVI pre, peri and post-implantation assessments — Examples
64 Bibliography

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BS EN ISO 5840-3:2021
$198.66