Abstract

ISO 25539-1:2003 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.

ISO 25539-1:2003 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.

ISO 25539-1:2003 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.

ISO 25539-1:2003 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.

ISO 25539-1:2003 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.