标准号：ISO 25539-1-2003
实施状态：作废
中文名称：心血管植入物.血管内器械.第1部分:血管内假体
英文名称：Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
发布日期：2003-03
被替代标准：ISO 25539-1-2017
代替标准：ISO/FDIS 25539-1-2002
采用标准：DIN EN ISO 25539-1-2009,IDT;DIN EN ISO 25539-1-2009,IDT;DIN EN ISO 25539-1-2008,IDT;DIN EN ISO 25539-1/A1-2009,IDT;ANSI/AAMI/ISO 25539-1-2003,IDT;BS EN ISO 25539-1-2009,IDT;EN ISO 25539-1-2008,IDT;EN ISO 25539-1-2009,IDT;prEN ISO 25539-1-2008,IDT;prEN ISO 25539-1-2008,IDT;NF S94-203-1-2008,IDT;NF S94-203-1-2009,IDT;S94-203-1PR,IDT;SN EN ISO 25539-1-2008,IDT;SN EN ISO 25539-1-2009,IDT;OENORM EN ISO 25539-1-2009,IDT;OENORM EN ISO 25539-1-2009,IDT;OENORM EN ISO 25539-1-2008,IDT;PN-EN ISO 25539-1-2009,IDT;PN-EN ISO 25539-1-2009,IDT;UNE-EN ISO 25539-1-2009,IDT;UNE-EN ISO 25539-1 V2-2009,IDT
起草单位：ISO/TC 150
标准简介：1 This part 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, which specifies general requirements for the performance of non-active surgical implants.
2 This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
3 This part of ISO 25539 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
4 This part of ISO 25539 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.
5 This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the endovascular system (defined in 3.6), such as balloon angioplasty devices.
文件格式：PDF
文件大小：328.58KB
文件页数：50
（以上信息更新时间为：2019-11-23）
ISO 25539-1-2003 心血管植入物.血管内器械.第1部分_血管内假体.pdf
(328.58 KB)
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