I.S. EN ISO 5840-2:2021
Current
The latest, up-to-date edition.
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840- 2:2021)
Hardcopy , PDF
English
21-02-2021
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Design verification and validation
Annex A (informative) Surgical heart valve substitute hazard analysis example
Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers
Annex C (informative) Preclinical in vivo evaluation
Annex D (informative) Description of the surgical heart valve substitute and system
Annex E (informative) Examples of components of some surgical heart valve substitutes and systems
Annex F (informative) Guidelines for verification of hydrodynamic performance — Pulsatile flow testing
Annex G (informative) Examples of design specific testing
Annex H (informative) Fatigue assessment
Annex I (normative) Methods of evaluating clinical data against objective performance criteria
Annex J (normative) Adverse event classification during clinical investigation
Bibliography
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.
| Committee |
TC 150
|
| DocumentType |
Standard
|
| Pages |
68
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 5840-2:2021 | Identical |
| ISO 5840-2:2021 | Identical |
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