GB/T 12279.3-2025 Active
GB/T 12279.3-2025 Cardiovascular implants—Cardiac valve prostheses—Part 3:Heart valve substitutes implanted by transcatheter techniques
Abstract
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).
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 12279.3-2025 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2026-05-01 |