ISO 25539-1:2017规定了血管内系统（假体和交付系统）的评估要求，以及制造商基于当前医学知识提供的有关命名、设计属性和信息的要求。体外试验方法的制定指南包含在本文件的资料性附录中。本文件可被视为ISO 14630的补充，ISO 14630规定了非活性外科植入物性能的一般要求。 ISO 25539-1:2017适用于血管内系统，用于治疗动脉瘤、狭窄或其他血管异常或病理（如解剖、横断）或在血管之间建立分流[如建立经颈静脉肝内门体分流术（TIPS）]。有些要求针对动脉瘤或狭窄的血管内治疗。 虽然血管内系统的使用不包括动脉瘤或狭窄的治疗（例如解剖、横断、分流）在本文件的范围内，但具体要求和测试未作说明。类似地，特定的假体配置（如开窗、分支）也在范围内，但没有对这些设备的具体要求和测试进行说明。 ISO 25539-1:2017不适用于血管封堵器，对侧髂动脉封堵器作为主动脉-单髂血管内假体的组成部分除外。尽管对侧髂动脉封堵器作为主动脉-单髂动脉血管内假体的组成部分使用时在本文件的范围内，但并未对这些装置的具体要求和测试进行说明。 用于使假体与血管壁或重叠部件充分并置的球囊在本文件范围内，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，特别是球囊与血管内假体的使用。 ISO 25539-1:2017不适用于引入血管内系统之前使用的程序和设备，如球囊血管成形术设备。 由血管内假体组件构成的带瓣导管的瓣膜组件以及带瓣组件和血管内假体组件的组合不在本文件范围内。本文件有助于确定带瓣导管的血管内假体组件的适当评估，但未描述这些设备的具体要求和测试。 注1:心脏瓣膜导管在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:血管装置药物组合产品在ISO 12417的范围内。 ISO 25539-1:2017未涉及用于血管内假体构建的活组织和非活生物材料的要求和评估。 本文件不涉及用于血管内假体构建的可吸收材料的降解和其他时间相关方面的要求和评估。 注3:可吸收材料在ISO/TS 17137和ISO/TR 37137的范围内。

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.