GB 12264-1990
Replaced
YY/T 0809.13-2020
Active
Industry standards-Medicine
YY/T 0809.13-2020 Implants for surgery—Partial and total hip joint prostheses—Part 13:Determination of resistance to torque of head fixation of stemmed femoral components
YY/T 0809.13-2020 Implants for surgery—Partial and total hip joint prostheses—Part 13:Determination of resistance to torque of head fixation of stemmed femoral components
Basic Information
Standard Code:
YY/T 0809.13-2020
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:
2020-02-21
Implement Date:
2021-01-01
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:
8 pages
Scope
YY/T 0809的本部分规定了在特定的实验室条件下测定使髋关节假体股骨球头的固定发生松脱(在髋关节假体中球头预期相对于颈部不能旋转)所需扭矩的方法。
本部分适用于部分或全髋关节假体的股骨部件，其中股骨球头和股骨颈/柄(在下文中称为锥体)通过圆锥锁定或其他方式固定在一起，其中股骨球头和锥体是独立的部件，它们由金属或非金属材料制成。
本部分不包括检查试样的方法；试样检查应由测试实验室和试样提供方协商。
Development Information
Drafting Units:
天津市医疗器械质量监督检验中心、创生医疗器械(中国)有限公司、上海大学机电工程与自动化学院、北京纳通科技集团有限公司
Drafting Persons:
董双鹏、李文娇、陈长胜、王剑、华子恺、蔡鹏、李仁耀、赵文文
Same series standard
Referenced Standards
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
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
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
Adopt standards
ISO 7206-13:2016
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced