GB/T 12279.2-2024 Active National standards

GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes

Publish Date: 2024-06-29 Implement Date: 2025-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 12279.2-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-06-29

Implement Date: 2025-07-01

Pages: 36 pages

Scope

This document specifies the operating conditions and performance requirements for surgical implantable artificial heart valves, and 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, which include 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 artificial heart valves that are typically implanted into humans using direct visual methods under extracorporeal circulation. It also applies to newly developed and modified artificial heart valves, as well as to the accessories, packaging, and markings required for implanting and determining the appropriate size of implanted artificial heart valves.