YY 0502-2026 Pending Industry standards-Medicine

YY 0502-2026 Joint replacement implants—Knee joint prostheses—Fundamental requirements

YY 0502-2026 Joint replacement implants—Knee joint prostheses—Fundamental requirements

Publish Date: 2026-03-09 Implement Date: 2029-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0502-2026
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: 2026-03-09
Implement Date: 2029-03-01
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

本文件规定了膝关节假体的基本要求,描述了相应的试验方法。
本文件适用于由金属、常规超高分子量聚乙烯、陶瓷材料制成的膝关节置换术使用的部分与全膝关节假体。

Development Information

Word Count: 21 Thousand words Pages: 20 pages

Replace the following standards

Referenced Standards

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 12417.2-2025 Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 2:Particular requirements for joint replacement implants GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.3-2024 Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological test methods GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 19701.1-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1:Powder form GB/T 19701.2-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2:Moulded forms GB/T 22750.1-2024 Implants for surgery—Ceramic materials—Part 1:Ceramic materials based on high purity alumina GB/T 22750.2-2024 Implants for surgery—Ceramic materials—Part 2:Composite materials based on a high purity alumina matrix with zirconia reinforcement GB 23101.2-2008 Implants for surgery—Hydroxyapatite—Part 2:Coatings of hydroxyapatite GB/T 23101.3-2010 Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity and phase purity GB/T 23101.3-2023 Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity ratio and phase purity GB/T 23101.4-2008 Implants for surgery—Hydroxyapatite—Part 4:Determination of coating adhesion strength GB/T 23101.4-2023 Implants for surgery—Hydroxyapatite—Part 4:Determination of coating adhesion strength YY 0117.2-2005 Implants for surgery—Forgings, castings for bone joint prostheses—ZTi6Al4V titanium alloy castings YY 0117.2-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 2:ZTi6Al4V titanium alloy castings YY 0117.3-2005 Implants for surgery—Forgings,castings for bone joint prostheses—Cobalt chromium molybdenum alloy castings YY 0117.3-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 3:Cobalt chromium molybdenum alloy castings YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants YY/T 0810.1-2010 Implants for surgery—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 YY/T 0924.2-2014 Implants for surgery—Components for partial and total knee joint prostheses—Part 2:Articulating surfaces made of metal,ceramic and plastics materials YY/T 0924.2-2024 Joint replacements—Components for partial and total knee joint prostheses—Part 2:Articulating surfaces made of metal,ceramic and plastics materials YY/T 0988.2-2016 Coatings of surgical implants—Part 2:Titanium and titanium-6 aluminum-4 vanadium alloy powders YY/T 0988.11-2016 Coatings of surgical implants—Part 11:Tension testing method of calcium phosphate coating and metallic coatings YY/T 0988.12-2016 Coatings of surgical implants—Part 12:Shear testing method of calcium phosphate coating and metallic coatings YY/T 0988.13-2016 Coatings of surgical implants—Part 13:Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating YY/T 0988.15-2016 Coatings of surgical implants—Part 15:Test methord for abrasion resistance testing of metallic thermal spray coatings YY/T 1507.1-2016 Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder—Part 1:Determination of titanium by ICP-MS YY/T 1507.2-2016 Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder—Part 2:Determination of chlorine by ion chromatography YY/T 1507.3-2016 Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder—Part 3:Determination of calcium by ICP-MS YY/T 1507.4-2016 Determination the content of impurity element in the implant for surgery ultra-igh molecular weight polyethylene powder—Part 4:Determination of aluminum by ICP-MS YY/T 1706.1-2020 Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic surgical implants—Part 1:General requirements YY/T 1715-2020 Implants for surgery—Ceramic materials based on yttria-stabilized tetragonal zirconia(Y-TZP) 中华人民共和国药典

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