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Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 外科瓣膜假体的尺寸参数:关于ISO 5840-2应用的要求
发布日期: 2023-05-17
本文件描述了外科瓣膜(此处和下文仅提及机械瓣膜和带支架的生物假体瓣膜)尺寸参数的体外测量方法。它代表了制造商、独立生物工程师和临床医生之间达成的共识,并以实验室间研究为基础。 本文件涉及外科心脏瓣膜假体,旨在与ISO 5840-1:20 21和ISO 5840-2:20 21结合使用。如有说明,本文件的要求阐明了ISO 5840-1和/或ISO 5840-2的某些要求。包括柔性瓣叶(生物假体)和刚性(机械)瓣膜的具体方法。不包括无缝合瓣膜、无支架瓣膜和带瓣导管。

This document describes in vitro methods of measurement of the sizing parameters for surgical valves (referring to mechanical and stented bioprosthetic valves only here and hereafter). It represents a consensus reached among manufacturers, independent bioengineers and clinicians, and is underpinned by interlaboratory studies.

This document relates to surgical heart valve prostheses and is intended to be used in conjunction with ISO 5840-1:2021 and ISO 5840-2:2021. Where noted, the requirements of this document clarify certain requirements of ISO 5840-1 and/or ISO 5840-2. Specific methodologies are included for flexible leaflet (bioprosthetic) and rigid (mechanical) valves. Sutureless valves, stentless valves and valved conduits are not included.

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归口单位: ISO/TC 150/SC 2
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