ISO 25539-1:2017规定了根据当前医学知识对制造商提供的术语，设计属性和信息对血管内系统（假体和输送系统）进行评估和要求的要求。本文件资料性附录中列出了体外测试方法的发展指导。该文件可以被认为是ISO 14630的补充，其规定了非活性外科植入物的性能的一般要求。 ISO 25539-1:2017适用于用于治疗动脉瘤，狭窄或其他血管异常或病理（例如解剖，横切）或在血管之间产生分流的血管内系统[例如，创建经颈静脉肝内门体分流术（TIPS）]。一些要求是特定于血管内治疗动脉瘤或狭窄的。虽然除了治疗动脉瘤或狭窄（例如解剖，横切，分流）之外的血管内系统的使用在本文档的范围内，但是没有描述具体要求和测试。类似地，具体的假体构造（例如，开窗，分支）在范围内，但是没有描述这些装置的具体要求和测试

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.