BS EN 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.

This document 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.

This document 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 contralateral 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.

This document 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.

This document does not address the requirements for, and the evaluation of, viable tissues and nonviable biologic materials used in the construction of endovascular prostheses.


Cross References:
ISO 7198:2016
ISO 10993-1
ISO 11135
ISO 11137
ISO 11607-1
ISO 13485
ISO 14160
ISO 14630:2012
ISO 14937
ISO 14971
ASTM F2503
ISO 594-1
ISO 594-2
ISO 5840-1
ISO 10555-1
ISO 10555-4
ISO 11070
ISO 14155
ISO 15223-1
ISO 16429
ISO 17475
ISO 17665-1
ISO/IEC 17025
ISO/TS 17137
ISO/TR 37137
ANSI/AAMI ST67
ASTM F640
ASTM F746
ASTM F2052
ASTM F2119
ASTM F2129
ASTM F2182
ASTM F2213
ASTM F2394
ASTM F2477
ASTM F2914
ASTM F2942
ASTM F3044
ASTM F3067
ASTM F3044
ASTM G5
ASTM G61
ASTM G71
ASTM G102
EN 556
93/42/EEC


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