GB 12264-1990
Replaced
YY 0118-2026
Pending
Industry standards-Medicine
YY 0118-2026 Joint replacement implants—Hip joint prostheses—Fundamental requirements
YY 0118-2026 Joint replacement implants—Hip joint prostheses—Fundamental requirements
Basic Information
Standard Code:
YY 0118-2026
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
本文件规定了部分和全髋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、陶瓷材料制成的髋关节置换术使用的部分与全髋关节假体。
Development Information
Replace the following standards
Referenced Standards
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 0809.2-2010 Implants for surgery—Partial and total hip joint prostheses—Part 2:Articulating surfaces made of metallic,ceramic and plastics materials
YY/T 0809.2-2020 Implants for surgery—Partial and total hip joint prostheses—Part 2:Articulating surfaces made of metallic,ceramic and plastics materials
YY/T 0809.4-2010 Implants for surgery—Partial and total hip joint prostheses—Part 4:Determination of endurance properties of stemmed femoral components
YY/T 0809.4-2018 Implants for surgery—Partial and total hip joint prostheses—Part 4:Determination of endurance properties and performance of stemmed femoral components
YY/T 0809.6-2010 Implants for surgery—Partial and total hip joint prostheses—Part 6:Determination of endurance properties of head and neck region of stemmed femoral components
YY/T 0809.6-2018 Implants for surgery—Partial and total hip joint prostheses—Part 6:Endurance properties testing and performance requirements of neck region of stemmed femoral components
YY/T 0920-2014 Non-active surgical implants—Joint replacement implants—Specific requirements for hip-joint replacement implants
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
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