ISO/TR 12417-2:2022 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 12417-2:2022

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：2022-07

标准范围

本文档提供以下区域的特定信息:—？世界各国和地区血管器械药物组合产品（VDDCP）的本地提交和批准；—？与药物成分有关的变化，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？的补充14630，其中规定了非活性外科植入物性能的一般要求。本文件也被视为ISO12417-1，以及任何相关设备特定标准，如ISO25539系列血管内器械的具体要求。本文件还涉及不一定是永久植入物的VDDCP。

This document 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 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.This document 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. This document also addresses VDDCPs that are not necessarily permanent implants.

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