根据当前的技术和医学知识，规定了血管装置药物组合产品（VDDCP）的要求。VDDCP是具有各种临床适应症的医疗设备，用于人类血管血液系统。VDDCP包含作为一个整体部分的物质，如果单独使用，可被视为药物产品（药品），但药物的作用是辅助于设备的作用，并支持设备的主要作用模式。关于安全，概述了预期性能、设计属性、材料、设计评估、制造、灭菌包装和制造商提供信息的要求。对于植入产品，ISO/TS 12417应被视为ISO 14630的补充，ISO 14630规定了非植入产品性能的一般要求- 主动外科植入物。还应被视为相关设备特定标准的补充，如ISO 25539系列，规定了血管内设备的要求。列出的要求还涉及不一定是永久性植入物的VDDCP。

Specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, 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 device and supports the primary mode of action of the device. With regard to safety, outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information supplied by the manufacturer. For implanted products, ISO/TS 12417 should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. Should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed also address VDDCPs that are not necessarily permanent implants.