I.S. EN ISO 5840-1:2021
Current
The latest, up-to-date edition.
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
Hardcopy , PDF
English
21-02-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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) Rationale for the provisions of ISO 5840-1
Annex B (normative) Packaging
Annex C (normative) Product labels, instructions for use, and training
Annex D (normative) Sterilization
Annex E (normative) In vitro test guidelines for paediatric devices
Annex F (informative) Corrosion assessment
Annex G (informative) Echocardiographic protocol
Annex H (informative) Assessment of implant thrombogenic and haemolytic potential
Annex I (informative) Guidelines for hydrodynamic performance characterization by steady flow testing
Annex J (normative) Durability testing
Annex K (informative) Fatigue assessment
Annex L (normative) Clinical investigation endpoints for heart valve replacement devices
Bibliography
This document is applicable to heart valve substitutes intended for implantation and provides general requirements.
| Committee |
TC 150
|
| DocumentType |
Standard
|
| Pages |
96
|
| 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 |
| ISO 5840-1:2021 | Identical |
| EN ISO 5840-1:2021 | Identical |
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