GB/T 12279.3-2025
ActiveCardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
心血管植入器械 人工心脏瓣膜 第3部分：经导管植入式人工心脏瓣膜
Application Summary AI generated
This standard specifies requirements and test methods for heart valve substitutes delivered via transcatheter techniques, such as transcatheter aortic valve implantation (TAVI) devices. It is applied in the medical device industry for the design, preclinical evaluation, and quality control of these minimally invasive implants. The standard ensures safety and performance for devices used to treat valvular heart disease without open-heart surgery.
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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.