Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/DAM 1:2024); German and English version EN ISO 5840-3:2021/prA1:2024
Abstract
This document specifies requirements for all devices intended for implantation in human hearts as a minimally invasive implanted heart valve substitute. This document is applicable to both newly developed and modified minimally invasive implanted heart valve substitutes and to the accessory devices, packaging and labeling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. It outlines an approach for qualifying the design and manufacture of a minimally invasive heart valve substitute through risk management. The selection of appropriate qualification tests and methods are to be 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 preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document imposes design specifications and minimum performance specifications for minimally invasive implanted heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This document is not applicable to heart valve substitutes designed for implantation in artificial hearts or heart assist devices and does not specifically address requirements for valve-in-valve configurations.
Begin
2023-12-01
WI
00285148
Planned document number
DIN EN ISO 5840-3/A1
Project number
02703419
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 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/DAM 1:2024); German and English version EN ISO 5840-3:2021/prA1:2024
2024-03
Order from DIN Media
