ISO/TS 12417:2011 心血管植入物和体外系统 血管器具-药物组合产品

标准编号：ISO/TS 12417:2011

中文名称：心血管植入物和体外系统 血管器具-药物组合产品

英文名称：Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products

发布日期：2011-06

标准范围

ISO/TS 12417:2011规定了基于当前技术和医学知识的血管装置药物组合产品（VDDCPs）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，ISO/TS 12417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的信息的要求。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。ISO/TS 12417还应被视为相关设备特定标准的补充，如ISO 25539系列，其中规定了血管内设备的要求。ISO/TS 12417中列出的要求也涉及不一定是永久性植入物的VDDCP。如果输送系统或输送系统的部件构成血管装置的一个组成部分，并且是药物覆盖的（例如，药物覆盖的球囊导管和药物覆盖的导丝），则其包含在ISO/TS 12417的范围内。ISO/TS 12417中未涉及不含药物覆盖物且主要作用方式为输送药物的泵和输液导管。在VDDCP引入之前和之后使用的程序和设备（例如球囊血管成形术设备）如果不影响药物，则不在ISO/TS 12417的范围内-设备的相关方面。ISO/TS 12417在VDDCPs的药理学评估方面并不全面。关于不同相关国家和地区当局要求的一些信息见附件。ISO/TS 12417针对VDDCP的生物可吸收成分（例如涂层）与装置的药物相关方面进行了阐述。ISO/TS 12417没有解决与活组织和非活生物材料相关的问题。

ISO/TS 12417:2011 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, ISO/TS 12417 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. ISO/TS 12417 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 in ISO/TS 12417 also address VDDCPs that are not necessarily permanent implants.Delivery systems or parts of the delivery system are included in the scope of ISO/TS 12417 if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).Pumps and infusion catheters which do not contain drug coverings, and whose primary mode of action is to deliver a drug, are not addressed in ISO/TS 12417.Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of ISO/TS 12417 if they do not affect the drug-related aspects of the device.ISO/TS 12417 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different related national and regional authorities is given in an annex.Bioabsorbable components of VDDCPs (e.g. coatings) are addressed by ISO/TS 12417 in their connection with drug-related aspects of the device.ISO/TS 12417 does not address issues associated with viable tissues and non-viable biological materials.

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