Abstract

This document is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of this International Standard provide specific requirements. This document is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. This document outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document defines operational conditions for heart valve substitutes. This document excludes homografts.

Begin

2023-12-01

WI

00285146

Planned document number

DIN EN ISO 5840-1/A1

Project number

02703420

Responsible national committee

NA 027-05-06 AA - Cardiovascular implants  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

Responsible international committee

ISO/TC 150/SC 2/WG 1 - Cardiac valves  

draft standard

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/DAM 1:2024); German and English version EN ISO 5840-1:2021/prA1:2024
2024-03
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previous edition(s)

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021); German version EN ISO 5840-1:2021
2021-05

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