DIN EN ISO 25539-1:2018
心血管植入物.心血管裝置.第1部分:心血管假體(ISO 25539-1-2017);德文版本EN ISO 25539-1-2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017

標準號

DIN EN ISO 25539-1:2018

發布

2018年

發布單位

德國標準化學會

當前最新

DIN EN ISO 25539-1:2018

 

 

引用標準

A ANSI/AAMI ST 67-2011 ASTM F2052-15 ASTM F2119-07 ASTM F640-12 ASTM F746-04 DIN EN ISO 10555-1:2018 DIN EN ISO 10555-4:2013 DIN EN ISO 10993-1:2010 DIN EN ISO 11070:2015 DIN EN ISO 11135:2014 DIN EN ISO 11607-1:2017 DIN EN ISO 13485:2016 DIN EN ISO 14155:2012 DIN EN ISO 14160:2011 DIN EN ISO 14630:2013 DIN EN ISO 14937:2010 DIN EN ISO 14971:2013 DIN EN ISO 15223-1:2017 DIN EN ISO 17475:2008 DIN EN ISO 17665-1:2006 DIN EN ISO 5840-1:2015 DIN EN ISO 7198:2017 DIN EN ISO/IEC 17025:2018

被代替標準

DIN EN ISO 25539-1:2017

適用范圍

Part 1 of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630. This International Standard is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. This International Standard is in addition applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.

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