标准编号：ISO 5840-3:2021
中文名称：心血管植入物 心脏瓣膜假体 第3部分：通过导管技术植入心脏瓣膜替代品
英文名称：Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
发布日期：2021-01
标准范围
This document is applicable to all devices intended for implantation as a transcatheter heart valve
substitute.
This document is applicable to transcatheter heart valve substitutes and to the accessory devices,
packaging and labelling required for their implantation and for determining the appropriate size of
heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of
a transcatheter heart valve substitute through risk management. The selection of appropriate
verification/validation tests and methods are to be derived from the risk assessment. The tests can
include those to assess the physical, chemical, biological and mechanical properties of heart valve
substitutes and of their materials and components. The tests can also include those for preclinical in
vivo evaluation and clinical evaluation of the finished heart valve substitute.
This document defines operational conditions and performance requirements for transcatheter heart
valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This document includes considerations for implantation of a transcatheter heart valve substitute inside
a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).
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