DANSK DSF/FPREN ISO 25539-1 PDF

1.1 Part 1 of ISO 25539 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 standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. 1.2 This part of ISO 25539 is applicable to endovascular systems used to treat aneurysms, stenoses, or other vascular anomalies or pathologies, 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 the other uses of endovascular systems are within the scope of this standard, 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.