GB 12279-2008
AbolishedCardiovasular implants - Cardiac valve prostheses
心血管植入物 人工心脏瓣膜
Application Summary AI generated
GB 12279-2008 specifies safety, performance, and testing requirements for cardiac valve prostheses used in cardiovascular implant surgery. It applies to both mechanical and bioprosthetic heart valves intended for human implantation, covering design, materials, durability, and biocompatibility. This standard is used by medical device manufacturers, regulatory bodies, and testing laboratories in China to ensure the quality and reliability of artificial heart valves before clinical use.
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