I.S. EN ISO 5840-3:2021
Current
The latest, up-to-date edition.
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
Hardcopy , PDF
English
21-02-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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) Description of the transcatheter heart valve system
Annex B (informative) Transcatheter heart valve substitute hazard analysis example
Annex C (informative) Guidelines for verification of hydrodynamic performance —
Annex D (normative) Requirements for delivery system design and evaluation
Annex E (informative) Examples of design specific testing
Annex F (informative) Preclinical in vivo evaluation
Annex G (normative) Adverse event classification during clinical investigation
Annex H (informative) Multimodality imaging of TAVI and TMVI pre, peri and postimplantation
Bibliography
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