YY/T 0651.2-2020 Active Industry standards-Medicine

YY/T 0651.2-2020 Implants 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

Publish Date: 2020-09-27 Implement Date: 2021-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0651.2-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2020-09-27

Implement Date: 2021-09-01

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: 12 pages

Scope

YY/T 0651的本部分规定了按YY/T 0651.1或YY/T 0651.3进行全髋关节假体磨损试验后利用质量法和体积法来评估髋臼组件磨损的方法。本标准适用于全髋关节假体。
注：有些研究者曾遇到有机物沉积明显影响本测试结果的问题，尤其是硬面和硬面组合时，此问题更加严重。本部分并没有给出具体的预防措施，但如果能够采用本部分列出的清洗技术，可以减少此种杂质产生的影响。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、西安交通大学机械工程学院、上海大学机电工程与自动化学院、苏州微创关节医疗科技有限公司

Drafting Persons:

李文娇、李楠、王玲、华子恺、俞天白、董恩纯、贾海立、许敏

Word Count: 12 Thousand words Pages: 12 pages

Same series standard

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

Replace the following standards

YY/T 0651.2-2008 Implant for surgery—Wear of total hip-joint prostheses—Part 2:Methods of measurement

Referenced Standards

YY/T 0651.1-2008 Implant 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 0651.1-2016 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 0651.3-2020 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 14242-2:2016

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26

GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04