ISO/TS 17137:2021 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 17137:2021

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：2021-09

标准范围

本文件规定了可吸收心血管植入物的设计评估要求和建议，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或组件或两者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，在引入可吸收心血管植入物之前和之后使用的程序和设备（例如球囊血管成形术设备）如果不影响植入物的吸收方面，则不在本文件范围内。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。注？1？ISO？12417-1阐述了心血管装置药物组合产品（例如涂层）的可吸收成分与装置药物相关方面的一些方面。注2:吸收、降解和相关术语的术语解释见附件A。

This document establishes design evaluation requirements and recommendations 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 intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both.

This 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 can 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.

NOTE 1    Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1.

NOTE 2    An explanation of the nomenclature of absorb, degrade and related terms can be found in Annex A.

标准预览图