标准编号：ISO 5840-2:2021
中文名称：心血管植入物 心脏瓣膜假体 第2部分：外科植入心脏瓣膜代用品
英文名称：Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
发布日期：2021-01
标准范围
This document is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for
examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and
to the accessory devices, packaging, and labelling required for their implantation and for determining
the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating 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 can include those to assess the
physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of
their materials and components. The tests can 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 some heart valve substitutes (e.g. sutureless), the requirements of both this document and
ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are
based on the results of the risk analysis.
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