ISO/TS 20721:2020 外科植入物 可吸收金属植入物评估的一般指南和要求

标准编号：ISO/TS 20721:2020

中文名称：外科植入物 可吸收金属植入物评估的一般指南和要求

英文名称：Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants

发布日期：2020-09

标准范围

本文件确立了目前公认的方法和评价可吸收金属和全部或部分由其制成的植入物的体外和体内性能时所需的特殊考虑。本文件描述了这些金属的评价如何不同于用于永久性不可吸收可植入植入物（或子组件）的评价，因为可吸收金属植入物（或子组件）通过设计旨在被宿主完全吸收。本文件提供了关于可吸收金属制成的医用植入物的材料考虑、体外降解/疲劳表征和生物学评价的指南。所提供的内容旨在使这些材料和植入物的评价更加清晰，以提高对关键因素的认识，并减少产生错误或误导性试验结果的可能性。虽然本文件和本文描述的参考标准包含对当前实践的程序或规范的许多建议的改变或修改，但所提供的内容旨在补充而不是取代关于可植入植入物评估的当前惯例。本文件涵盖了一般可吸收金属特定属性的评价，并非旨在涵盖应用或植入物的特定考虑因素。因此，咨询相关植入物和/或应用特定标准是很重要的。本文件不适用于与可吸收金属植入物联合使用的不可吸收或非金属部件（如聚合物涂层、药物、不可吸收金属）。

This document established the currently recognized approaches and special considerations needed when evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, in whole or in part, from them. This document describes how the evaluation of these metals can differ from those utilized for permanent non-absorbable implantable implants (or subcomponents), in that absorbable metal implants (or subcomponents) are — by design — intended to be absorbed in their entirety by the host.This document provides guidance regarding the materials considerations, in vitro degradation/fatigue characterization, and biological evaluation of medical implants made of absorbable metals. The provided content is intended to deliver added clarity to the evaluation of these materials and implants to increase awareness of critical factors and reduce potential for generation of erroneous or misleading test results.While this document and the herein described referenced standards contain many suggested alterations or modifications to currently practiced procedures or specifications, the provided content is intended to complement, and not replace, current conventions regarding the assessment of implantable implants.This document covers the evaluation of absorbable metal specific attributes in general and is not intended to cover application or implant specific considerations. Thus, it is important to consult relevant implant and/or application specific standards.This document does not apply to non-absorbable or non-metallic components (e.g. polymeric coatings, pharmaceuticals, non-absorbable metals) used in conjunction with absorbable metal implants.

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