YY/T 0651.4-2025 Pending Industry standards-Medicine

YY/T 0651.4-2025 Joint replacements—Wear of total hip-joint prostheses—Part 4:Testing hip prostheses under variations in component positioning which results in direct edge loading

Publish Date: 2025-09-15 Implement Date: 2026-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0651.4-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-09-15

Implement Date: 2026-10-01

Publisher: 国家药品监督管理局

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会骨科植入物分技术委员会(SAC/TC 110/SC 1)

Pages: 20 pages

Scope

本文件描述了模拟髋臼部件大倾斜角和动态分离条件下髋关节假体边缘加载的测试条件。
本文件与YY/T 0651.1-2016或YY/T 0651.3结合使用。
本文件适用于全髋关节假体。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、苏州微创骨科学(集团)有限公司、凯尔测控技术(天津)有限公司、国家药品监督管理局医疗器械技术审评检查大湾区分中心、西安交通大学、北京科仪邦恩医疗器械科技有限公司

Drafting Persons:

张述、张博洋、王颖、俞天白、李炫、林强、孟雨柔、高进涛、韩丹、王玲、聂永嘉、江丽

Word Count: 26 Thousand words Pages: 20 pages

Referenced Standards

YY/T 0651.1-2016 Implants for surgery—Wear of total hip-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test YY/T 0651.2-2008 Implant for surgery—Wear of total hip-joint prostheses—Part 2:Methods of measurement YY/T 0651.2-2020 Implants for surgery—Wear of total hip-joint prostheses—Part 2:Methods of measurement YY/T 0651.3-2020 Implants for surgery—Wear of total hip-joint prostheses—Part 3:Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test

Adopt standards

ISO 14242-4:2018

Related Standards

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