GB/T 12279.1-2024 Active

This document specifies the general requirements for artificial heart valves intended for implantation into the human body and the operating conditions of artificial heart valves. This document describes the methods of verifying/confirming the design and manufacturing of artificial heart valves through risk management. Appropriate verification/confirmation tests and methods are selected through risk assessment, including physical, chemical, biological, and mechanical performance tests of artificial heart valves and their materials and components, as well as preclinical in vivo evaluations of finished artificial heart valves. This document applies to newly developed and modified artificial heart valves, as well as accessories, packaging, and markings required for implanting artificial heart valves and determining their sizes. Some provisions in this document apply to valves made from inactivated human tissue. This document does not apply to allograft valves, tissue-engineered heart valves (e.g., valves intended to regenerate in vivo), or heart valves specifically designed for implantation into circulatory support devices. Note: Appendix A explains the basic principles of this document.