GB/T 18375-2024 Active National standards

GB/T 18375-2024 Prosthetics—Structural testing of lower-limb prostheses—Requirements and test methods

Publish Date: 2024-11-28 Implement Date: 2025-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 18375-2024

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: 2024-11-28

Implement Date: 2025-03-01

Pages: 118 pages

Scope

Important Note: This document is applicable to evaluating whether lower limb prosthetic devices (structures) meet the strength requirements specified in GB/T 30659-2014, Section 4.4 (see Note 1). If prosthetic ankle-foot devices and foot components on the market have passed the relevant tests in this document and meet the strength requirements specified in GB/T 30659-2014, Section 4.4, they do not need to be re-inspected according to ISO 22675:2016.
Warning: This document is not suitable as a guide for selecting prosthetic devices (structures) in individual lower limb prosthetic prescriptions! Ignoring this warning may pose safety risks to amputees.
This document specifies the procedures for static and dynamic strength tests of lower limb prostheses (see Note 2), typically generating a composite test load with a single test force. The peak values of the various components of the composite load on the test samples typically occur at different moments during the support phase of walking.
The tests described in this document include:
——Static and dynamic tests of the main structures of all components;
——Static torsion tests of the substructures of all components;
——Static and dynamic tests of the substructures of ankle-foot devices and foot components, including the entire ankle device as a single component, or the ankle connection and all foot components as a single component, conducting static and dynamic tests separately;
——Static limit strength tests of the substructures of knee joints and all their connecting components or knee-tibia components and their adjacent components, when the knee joints provide knee-bending limit functions in the maximum flexion angle in the overall prosthesis;
——Static and dynamic tests of the substructures of all mechanical devices that lock the knee joint or knee-tibia components in the extended position.
The tests described in this document are applicable to specific types of a