GB/T 12279.2-2024
ActiveCardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
心血管植入器械 人工心脏瓣膜 第2部分：外科植入式人工心脏瓣膜
Application Summary AI generated
This standard specifies the requirements, test methods, and labeling for surgically implanted heart valve substitutes used to replace diseased or damaged native heart valves. It is applied in the medical device industry for the design, manufacturing, and quality control of mechanical and bioprosthetic heart valves intended for surgical implantation in patients. The standard ensures safety and performance in clinical use, particularly during regulatory evaluation and pre-market testing.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.