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  • DIN EN ISO 25539-1-2017
    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


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    標準號
    DIN EN ISO 25539-1-2017
    發布日期
    2017年09月
    實施日期
    2017年09月01日
    廢止日期
    中國標準分類號
    C45
    國際標準分類號
    11.040.40
    發布單位
    DE-DIN
    引用標準
    DIN EN ISO 5840-1-2015 DIN EN ISO 7198-2017 DIN EN ISO 10555-1-2013 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 11607-1-2014 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/IEC 17025-2005 DIN EN ISO 17475-2008 DIN EN ISO 17665-1-2006 ANSI/AAMI ST 67-2011 ASTM F 640-2012 ASTM F 746-2004 ASTM F 2052-2015 ASTM F 2119-2007 A
    代替標準
    DIN EN ISO 25539-1-2018
    被代替標準
    DIN EN ISO 25539-1-2009 DIN EN ISO 25539-1-2015
    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.

    DIN EN ISO 25539-1-2017系列標準





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