标准编号：ISO 5840-2:2015
中文名称：心血管植入物 心脏瓣膜假体 第2部分：外科手术植入心脏瓣膜替代品
英文名称：Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
发布日期：2015-09
标准范围
This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts,generally requiring cardiopulmonary bypass and generally with direct visualization.This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutesand to the accessories, packaging, and labelling required for their implantation and for determining theappropriate size of the surgical heart valve substitute to be implanted.This part of ISO 5840 outlines an approach for qualifying the design and manufacture of a surgical heartvalve substitute through risk management. The selection of appropriate qualification tests and methodsare 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 andcomponents. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluationof the finished surgical heart valve substitute.This part of ISO 5840 defines performance requirements for surgical heart valve substitutes whereadequate scientific and/or clinical evidence exists for their justification.For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this InternationalStandard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific devicedesign and shall be based on the results of the risk analysis.This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts orheart assist devices.This part of ISO 5840 excludes homografts.
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