GB/T 12279.1-2024
ActiveCardiovascular implants—Cardiac valve prostheses—Part 1:General requirements
心血管植入器械 人工心脏瓣膜 第1部分：通用要求
Application Summary AI generated
This standard specifies the general requirements for cardiac valve prostheses used as cardiovascular implants, covering aspects such as materials, design, performance, and testing. It is applied in the medical device industry for the development, manufacturing, and quality control of artificial heart valves intended for surgical implantation. The standard ensures safety and efficacy in clinical use, guiding regulatory compliance and evaluation for both manufacturers and testing laboratories.
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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.