AS ISO 15539-2003

Specifies, based on current medical knowledge, the evaluation of the ability of an endovascular device to meet specified medical situations. Additional recommendations on packaging and sterilization are also provided. This draft Standard will supplement ASISO14630, which specifies general requirements for the performance of non-active surgical implants. It is applicable to endovascular devices, such as endovascular prostheses, vascular stents and filters.