ISO/TR 12417-2:2017 心血管移植和体外系统 血管设备药物组合产品 第2部分：地方法规信息

标准编号：ISO/TR 12417-2:2017

中文名称：心血管移植和体外系统 血管设备药物组合产品 第2部分：地方法规信息

英文名称：Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information

发布日期：2017-11

标准范围

ISO/TR 12417-2:2017提供了以下方面的区域特定信息:-世界各国和地区的血管装置药物组合产品（VDDCPs）的本地提交和批准；-与含药部分相关的变化，以及不同地区如何评估这些变化。对于植入产品，本文件被视为ISO 14630的补充，ISO 14630规定了非活性外科植入物性能的一般要求。ISO/TR 12417-2:2017也被视为对ISO 12417？1和任何相关设备特定标准的补充，如规定血管内设备要求的ISO 25539系列。本文件中列出的要求也涉及不一定是永久植入物的VDDCP。

ISO/TR 12417-2:2017 provides region-specific information for- local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;- changes related to the drug containing part and how they are evaluated by the different local regions.For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.ISO/TR 12417-2:2017 is considered also as a supplement to ISO 12417？1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.

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