ISO/TS 17137:2019 心血管植入物和体外系统 心血管可吸收植入物

标准编号：ISO/TS 17137:2019

中文名称：心血管植入物和体外系统 心血管可吸收植入物

英文名称：Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

发布日期：2019-09

标准范围

本文件概述了可吸收心血管植入物的设计评估指南，该植入物用于治疗循环系统内的血管和/或血管空间，包括心脏和所有脉管系统。本文件旨在通过提供可吸收植入物和/或组件的特定指南来补充设备特定标准本文件适用于直接接触心血管系统的植入物，其预期作用是作用于循环系统。本文件不涉及与活组织、活细胞和/或含有非活生物材料及其衍生物的植入物相关的问题的具体评估。此外，可吸收心血管植入物（e。g、 如果球囊血管成形术设备不影响植入物的吸收，则不在本文件的范围内。心血管可吸收植入物可包含物质，如果单独使用，可被视为药物产品（药物产品），但药物的作用是辅助于植入物的作用，并支持植入物的主要作用模式。

This document outlines design evaluation guidelines for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is meant to supplement device-specific standards by providing guidelines specific for absorbable implants and/or componentsThis document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non- viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of This document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant.

标准预览图