YY/T 0809.10-2022 Active Industry standards-Medicine

YY/T 0809.10-2022 Implants for surgery—Partial and total hip-joint prostheses—Part 10:Determination of resistance to static load of modular femoral heads

Publish Date: 2022-05-18 Implement Date: 2023-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0809.10-2022

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: 2022-05-18

Implement Date: 2023-06-01

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: 13 pages

Scope

本文件规定了在特定的试验条件下导致股骨头压缩（断裂)或拉伸（解体)的静态力测量试验方法。
本文件适用于金属和非金属材料制成的部分或全髋关节置换中的组合式股骨头结构（例如：一个股骨头/股骨颈的锥形连接)。
本文件不涉及试验样品的检查和报告方法。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、苏州微创关节医疗科技有限公司、国家药品监督管理局医疗器械技术审评中心、创生医疗器械(中国)有限公司、北京蒙太因医疗器械有限公司、北京纳通科技集团有限公司、山东威高骨科材料股份有限公司

Drafting Persons:

赵丙辉、李沅、张路、李佳、俞天白、李炫、张家振、翟豹、陈长胜、王剑、许志勇、盛文杰、赵文文、李仁耀、鲁成林、魏悦

Word Count: 27 Thousand words Pages: 13 pages

Replace the following standards

YY/T 0809.10-2014 Implants for surgery—Partial and total hip joint prostheses—Part 10:Determination of resistance to static load of modular femoral heads

Referenced Standards

GB/T 231.1-2002 Metallic materials—Brinell hardness test—Part 1:Test method GB/T 231.1-2009 Metallic materials—Brinell hardness test—Part 1:Test method GB/T 231.1-2018 Metallic materials—Brinell hardness test—Part 1:Test method GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 16825.1-2002 Verification of static uniaxial testing machines—Part 1:Tension/compression testing machines—Verification and calibration of the force-measuring system GB/T 16825.1-2008 Verification of static uniaxial testing machines—Part 1:Tension/compression testing machines—Verification and calibration of the force-measuring system GB/T 16825.1-2022 Metallic materials—Calibration and verification of static uniaxial testing machines—Part 1:Tension/compression testing machines—Calibration and verification of the force-measuring system YY/T 0809.1-2010 Implants for surgery—Partial and total hip joint prostheses—Part 1:Classification and designation of dimensions

Adopt standards

ISO 7206-10:2018

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