Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008, IDT)
This Malaysian Standard specifies requirements for vascular stents, 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 MS ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
This standard includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of MS ISO 25539-1. The stent design might dictate the need to address functional requirements identified in both MS ISO 25539-1 and this standard.
Delivery systems are included in this s
Published
• (none) / (none) / (none)
PDF
02/05/2019
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NSC 18 - Medical Devices and Facilities for Healthcare
