The State Administration for Market Regulation (National Standards Committee) has approved the release of the national standard "Cardiovascular Implanted Devices - Artificial Heart Valves - Part 3: Transcatheter Implanted Artificial Heart Valves". The technology of artificial heart valves has developed rapidly in recent years, including mechanical valves, biological valves, and transcatheter implanted artificial heart valves. Transcatheter implantable artificial heart valve (hereinafter referred to as transcatheter valve) is an artificial heart valve implanted into the human body through minimally invasive intervention, used to treat heart valve diseases or defects. This standard specifies the operating conditions and performance requirements for transcatheter valves, establishes a series of design, manufacturing, and testing methods, including their physical, chemical, biological, and mechanical performance evaluations, as well as preclinical in vivo evaluations. In order to ensure the quality and safety of artificial heart valve products and regulate the healthy development of the industry, China has adopted the International Organization for Standardization (ISO 5840) series standards for artificial heart valves, and since 2024, has released the national standards for artificial heart valves (GB/T 12279) series. The release and implementation of this series of standards will help improve the safety and effectiveness of artificial heart valve products, better build a standard defense line to ensure heart health and safety, enhance the competitiveness of China's artificial heart valve products in the global market, and narrow the gap with the international advanced level. (New Society)
Edit:XieEnQi Responsible editor:XieEnQi
Source:people.cn
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