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YY 0502-2016 English Version, YY 0502-2016 Joint replacement implants―Knee joint prostheses (English Version) - Code of China
Position: Chinese Standard in English/YY 0502-2016
YY 0502-2016 Joint replacement implants―Knee joint prostheses (English Version)
Standard No.: YY 0502-2016 Status: valid remind me the status change
Word Count: 10500 words Price(USD): 160.0 remind me the price change
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Detail of YY 0502-2016
Introduction of YY 0502-2016
Contents of YY 0502-2016
Standard No.: YY 0502-2016
English Name: Joint replacement implants―Knee joint prostheses
Chinese Name: 关节置换植入物膝关节假体
Superseding: YY 0502-2005 Knee joint prostheses
1 Scope This standard specifies the terms and definitions and requirements for classification and designation of dimensions, expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer of knee joint prostheses. This standard is applicable to partial and total knee joint prostheses made of materials and by techniques specified in this standard. 2 Normative references The following documents for the application of this document are essential. Any dated reference, just dated edition applies to this document. For undated references, the latest edition of the normative document (including any amendments) applies. GB/T 10610	Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture GB/T 14233.1	Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods GB/T 14233.2	Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB/T 16886.7	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals GB 18278	Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization GB 18279	Medical devices - Validation and routine control of ethylene oxide sterilization GB 18280	Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization GB/T 19701.1	Implants for surgery - Ultra-high molecular weight polyethylene - Part 1: Powder form GB/T 19701.2	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms GB 23101.2	Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite YY 0117.1	Implants for surgery - Forgings, castings for bone joint prostheses - Ti6Al4V titanium alloy forgings YY 0117.2	Implants for surgery - Forgings, castings for bone joint prostheses - ZTi6Al4V titanium alloy castings YY 0117.3	Implants for surgery - Forgings, castings for bone joint prostheses - Cobalt chromium molybdenum alloy castings YY/T 0343	Liquid penetrant inspection of metallic surgical implants YY/T 0772.3	Implants for surgery Ultra-high-molecular-weight polyethylene Part 3: Accelerated ageing methods YY/T 0772.4	Implants for surgery Ultra-high-molecular-weight polyethylene Part 4: Oxidation index measurement method YY/T 0772.5	Implants for surgery Ultra-high-molecular-weight polyethylene Part 5: Morphology assessment method YY/T 0810.1	Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays YY/T 0811	Standard guide for extensively irradiation - Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications YY/T 0919	Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants YY/T 0924.1	Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions YY/T 0924.2	Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials ISO 6474-1	Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina ISO 6474-2	Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement ISO 13356	Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zireonia (Y-TZP) ISO 14630	Non-active surgical implants - General requirements ISO 14243-1	Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test ISO 14243-2	Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement ISO 14243-3	Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test ISO 21534	Non-active surgical implants - Joint replacement implants - Particular requirements ASTM F1044	Standard test method for shear testing of calcium phosphate coatings and metallic coatings ASTM F1147	Standard test method for tension testing of calcium phosphate and metallic coatings ASTM F1160	Standard test method for shear and bending fatigue testing of calcium phosphate and metallic medical and composite calcium phosphate/metallic coatings ASTM F1377	Standard specification for cobalt-28 chromium-6 molybdenum power for coating of orthopedic implants (UNS-R30075) ASTM F1580	Standard specification for titanium and titanium-6 aluminum-4 vanadium alloy powders for coatings of surgical implants ASTM F1854	Standard test method for stereological evaluation of porous coatings on medical implants ASTM Fl978	Standard test method for measuring abrasion resistance of metallic thermal spray coatings by using the taber abraser 3 Terms and definitions For the purpose of this document, the terms and definitions given in YY/T 0919, YY/T 0924.1 and ISO 21534 and the following apply. 3.1 conventional UHMWPE UHMWPE manufacture by compression or extrusion molding and not crosslinked prior to final sterilization 3.2 extensively radiation-cross-linked UHMWPE UHMWPE manufactured by compression or extrusion molding and subjected to the irradiation from gamma rays or electron beam at a dose higher than 40 kGy for improving wear resistance
Foreword	I 1 Scope 2 Normative references 3 Terms and definitions 4 Classification and designation of dimensions 5 Intended performance 6 Design attributes 7 Materials 8 Design evaluation 9 Manufacture 10 Sterilization 11 Packaging 12 Information supplied by the manufacturer Annex A (Normative) List of standards for materials found acceptable for the manufacture of knee joint prostheses Annex B (Normative) List of materials found acceptable or not acceptable for the manufacture of articulating surfaces of knee joint prostheses Annex C (Normative) List of materials found acceptable or non-acceptable for metallic combinations for use for non-articulating contacting surfaces of knee joint prostheses Annex D (Normative) List of standards for approved method for chemical analysis
*YY/T 0810.1-2010 Implants for surgery—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays
*YY/T 0919-2014 Non-active surgical implants―Joint replacement implants―Specific requirements for knee-joint replacement implants
*YY/T 0924.1-2014 Implants for surgery―Components for partial and total knee joint prostheses―Part 1:Classification, definitions and designation of dimensions
*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
Referred in YY 0502-2016:
Standard No. YY 0502-2016
YY 0502-2016
Joint replacement implants―Knee joint prostheses
关节置换植入物膝关节假体
YY 0502-2005 Knee joint prostheses
YY 0502-2016, YY/T 0502-2016, YYT 0502-2016, YY0502-2016, YY 0502, YY0502, YY/T0502-2016, YY/T 0502, YY/T0502, YYT0502-2016, YYT 0502, YYT0502