T/CSBME 045-2022 Active Group standards

T/CSBME 045-2022 Transcatheter Implantable Artificial Heart Valve Ex Vivo Fluid Dynamics Testing Method

Publish Date: 2022-01-15 Implement Date: 2022-03-01 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: T/CSBME 045-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2022-01-15

Implement Date: 2022-03-01

Pages: 32 pages

Scope

This document specifies the test methods for the in vitro hydrodynamics of transcatheter implantable artificial heart valves.
This document is applicable to transcatheter implantable artificial heart valves, mainly including: artificial heart valves for the left heart aortic valve and mitral valve, and artificial heart valves for the right heart pulmonary artery valve and tricuspid valve. The supporting structures of such valves can be made of metal materials and/or polymer materials, and the valve leaflets can be made of animal-derived and/or non-animal-derived materials.

Development Information

Word Count: 56 Thousand words Pages: 32 pages

Referenced Standards

YY/T 1449.3-2016 Cardiovascular implants—Cardiac valve prostheses—Part 3:Heart valve substitutes implanted by transcatheter techniques ISO 5840-1:2021 ISO 5840-2:2021 ISO 5840-3:2021