GB/T 12279.3-2025 Active National standards

GB/T 12279.3-2025 Cardiovascular implants—Cardiac valve prostheses—Part 3:Heart valve substitutes implanted by transcatheter techniques

Publish Date: 2025-04-25 Implement Date: 2026-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 12279.3-2025

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: 2025-04-25

Implement Date: 2026-05-01

Pages: 36 pages

Scope

This document specifies the operating conditions and performance requirements for catheter-implanted artificial heart valves (hereinafter referred to as catheter valves). This document establishes the design and manufacturing methods of catheter valves through risk management verification/validation. Appropriate verification/validation tests and methods are selected through risk assessment, which include evaluating the physical, chemical, biological, and mechanical properties of catheter valves and their materials and components, as well as preclinical in vivo evaluation of finished catheter valves. This document applies to all devices intended for catheter valve implantation, as well as newly developed and modified catheter valves. It also applies to accessories, packaging, and markings required for implanting and determining the appropriate size of catheter valves. This document includes precautions for implanting catheter valves into existing devices (such as intra-valve and intra-annular valves).