Abstract

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labeling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This document outlines an approach for qualifying the design and manufacture of a surgical 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 surgical 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 surgical heart valve substitute. This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For novel surgical heart valve substitutes (e.g., sutureless), the requirements of both this International Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis. This document excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This document excludes homografts.

Begin

2023-12-01

WI

00285147

Planned document number

DIN EN ISO 5840-2/A1

Project number

02703421

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 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024); German and English version EN ISO 5840-2:2021/prA1:2024
2024-03
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previous edition(s)

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021); German version EN ISO 5840-2:2021
2021-05

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