SS-EN-ISO-25539-1 › Historical Revision Information
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
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1.1 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. 1.2 This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. 1.3 This part of ISO 25539 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses. 1.4 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. 1.5 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.
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Designation Name
SS-EN ISO 25539-1:2009
Revision Level
2009 EDITION
Status
Superseded
Publication Date
May 25, 2009
Language(s)
English
Page Count
104
International Equivalent
EN ISO 25539-1:2009(IDT); ISO 25539-12003 incl Amd 1:2005(IDT)