AS ISO 25539.1-2003现行
Cardiovascular implants - Endovascular devices Endovascular prostheses
出版：Standards Australia
专家解读视频
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 AS ISO 14630, which specifies general requirements for the performance of non-active surgical implants. It is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
ISO 25539-1:2003 - Identical
