ISO 12417-1:2024 心血管植入物和体外系统 血管装置-药物组合产品 第1部分：一般要求

标准编号：ISO 12417-1:2024

中文名称：心血管植入物和体外系统 血管装置-药物组合产品 第1部分：一般要求

英文名称：Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements

发布日期：2024-02

标准范围

本文件规定了血管器械—药物组合产品（VDDCPs）的要求。关于安全性，本文件概述了预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供的信息的要求。对于植入产品，本文件旨在作为ISO？14630，其规定了非活性外科植入物性能的一般要求。本文件旨在作为相关器械特定标准的补充，如ISO？25539系列规定了血管内器械的要求。本文件中列出的要求还涉及非永久性植入物的VDDCP。注1？由于本文件涵盖的组合产品的设计存在差异，并且由于其中一些组合产品的开发相对较新，可接受的标准化体外试验结果和临床研究结果并不总是可用的。随着进一步的科学和临床数据的获得，可能需要对本文件进行适当的修订。本文件适用于输送系统或输送系统的一部分，其是血管装置的组成部分，并且是药物包覆的（例如，药物包覆的球囊导管和药物包覆的导丝）。本文件不适用于PMOA提供药物递送导管的器械（例如输注导管），除非其含有旨在对器械部件具有辅助作用的药物成分（例如抗菌涂层输注导管）。本文件不适用于引入VDDCP之前和之后使用的不影响药物的手术和器械（例如球囊血管成形术器械）-设备的相关方面。本文件未提供VDDCPs的全面药理学评价。注2？关于某些国家和区域当局的要求的一些信息见附件？B.本文件讨论了VDDCP的可吸收组分（例如涂层）与器械药物相关方面的连接。本文件未提供可吸收植入物和涂层的降解和其他时间依赖性方面的详尽列表。注3？有关可吸收涂层的更多信息，请参阅ISO/TS？17137和ASTM？F3036-13。本文件不涉及与有活力或无活力的生物材料如组织、细胞或蛋白质相关的问题。本文件不涉及与有源手术植入物（即需要不由人体或重力产生的动力的植入物）相关的问题。

This document specifies requirements for vascular device-drug combination products (VDDCPs).

With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to 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 permanent implants.

NOTE 1        Due to variations in the design of combination products covered by this document and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this document can be necessary.

This document applies to delivery systems or parts of the delivery system that are an integral component of the vascular device and that are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).

This document does not apply to devices whose PMOA provide a conduit for delivery of a drug (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter).

This document does not apply to procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) that do not affect the drug-related aspects of the device.

This document does not provide a comprehensive pharmacological evaluation of VDDCPs.

NOTE 2        Some information about the requirements of certain national and regional authorities is given in Annex B.

The connection of absorbable components of VDDCPs (e.g. coatings) with drug-related aspects of the device are addressed in this document. This document does not provide an exhaustive list of the degradation and other time-dependent aspects of absorbable implants and coatings.

NOTE 3        For more information on absorbable coatings, refer to ISO/TS 17137 and ASTM F3036-13.

This document does not address issues associated with viable or non-viable biological materials such as tissues, cells or proteins.

This document does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).

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