YY/T 0663-2008 Replaced Industry standards-Medicine

YY/T 0663-2008 Non active surgical implants—Particular requirements for cardiac and vascular implants—Specific requirements for arterial stents

Publish Date: 2008-04-25 Implement Date: 2009-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0663-2008

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2008-04-25

Implement Date: 2009-06-01

Pages: 23 pages

Scope

This standard specifies the specific requirements for arterial stents, endovascular prostheses, and their release processes used to correct or compensate for arterial defects. For safety reasons, based on EN ISO 14630 and EN 12006-3, this standard sets forth specific requirements in terms of expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information. This standard applies to arterial stents and endovascular prostheses used in the aorta, the neck portion of intracranial arteries, coronary arteries, intracranial arteries, peripheral arteries, pulmonary arteries, ascending aorta, and visceral arteries. This standard also includes endovascular prostheses used to treat aneurysms, arterial stenosis, or other vascular abnormalities.