心血管植入物. 血管内器械. 第1部分: 血管内假体

[中文适用范围]： 本文件规定了血管内系统（假体和输送系统）的评估要求，以及制造商根据当前医学知识提供的术语、设计属性和信息的要求。 体外测试方法开发指南包含在本文件的资料性附件中。 本文件可被视为 ISO 14630 的补充，该标准规定了无源手术植入物性能的一般要求。 本文件适用于用于治疗动脉瘤、狭窄或其他血管异常或病变（例如解剖、横断）或在血管之间创建分流[例如创建经颈静脉肝内门体分流（TIPS）]的血管内系统。 有些要求是针对动脉瘤或狭窄的血管内治疗的。 尽管除了治疗动脉瘤或狭窄（例如夹层、横切、分流）之外，血管内系统的使用也在本文件的范围内，但没有描述具体的要求和测试。 类似地，特定的假体配置（例如有孔、分支）也在范围内，但没有描述这些装置的特定要求和测试。 本文件不适用于血管封堵器，但用作主动脉-单髂血管内假体组成部分的对侧髂动脉封堵器除外。 尽管对侧髂动脉封堵器用作主动脉单髂血管内假体的组成部分时在本文件的范围内，但没有描述这些设备的具体要求和测试。 用于实现假体与血管壁或重叠部件的充分并置的球囊在本文件的范围内，即使它们不是血管内系统的组成部分。 本文件提供了超出 ISO 10555-4 要求的要求，特别是针对血管内假体球囊的使用。 本文件不适用于引入血管内系统之前使用的程序和设备，例如球囊血管成形术设备。 用血管内假体部件构造的带阀导管的阀部件以及带阀部件和血管内假体部件的组合被排除在本文件的范围之外。 本文件有助于确定对带阀导管的血管内假体组件的适当评估，但没有描述这些设备的具体要求和测试。 注 1：心脏阀门导管在 ISO 5840-1 的范围内。 本文件未涉及药物洗脱或药物涂层血管内假体的药理学方面。 注 2：血管器械-药物组合产品属于 ISO 12417 的范围。 本文件不涉及用于构建血管内假体的活组织和非活生物材料的要求和评估。  本文件未涉及血管内假体构造中使用的可吸收材料的降解和其他与时间相关的方面的要求和评估。 注 3：可吸收材料在 ISO/TS 17137 和 ISO/TR 37137 的范围内。 [外文原描述]： ISO 25539-1:2017 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. ISO 25539-1:2017 is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices. ISO 25539-1:2017 is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices. Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555‑4, specific to the use of balloons with endovascular prostheses. ISO 25539-1:2017 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices. The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. NOTE 1 Cardiac valved conduits are within the scope of ISO 5840‑1. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417. ISO 25539-1:2017 does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of endovascular prostheses. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document. NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.