GB 12264-1990
Replaced
YY/T 0810.1-2024
Active
Industry standards-Medicine
YY/T 0810.1-2024 Joint replacements—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays
YY/T 0810.1-2024 Joint replacements—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays
Basic Information
Standard Code:
YY/T 0810.1-2024
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:
2024-07-08
Implement Date:
2025-07-20
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:
16 pages
Scope
本文件描述了在特定实验室条件下，测定膝关节假体中支持和保护塑料关节面的胫骨托疲劳性能的试验方法。
本文件适用于覆盖内外侧胫骨的胫骨托。
本文件不适用于只用塑料材料制成的胫骨部件。
本文件不涉及试样最终状态的测试和报告方法，这些内容由测试实验室和试样提供方协商确定。
Development Information
Drafting Units:
天津市医疗器械质量监督检验中心、国家药品监督管理局医疗器械技术审评中心、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、北京市医疗器械审评检查中心、创生医疗器械(中国)有限公司
Drafting Persons:
张路、王涛、张皓成、史新立、郭晓磊、韩丹、张坤、郭旭、杨群、刘慧芬
Replace the following standards
Referenced Standards
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 0924.1-2014 Implants for surgery—Components for partial and total knee joint prostheses—Part 1:Classification, definitions and designation of dimensions
Adopt standards
ISO 14879-1:2020
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