標準編號:	YY 0502-2016
中文名稱:	關節置換植入物膝關節假體
英文名稱:	Joint replacement implants―Knee joint prostheses
中標分類:	C35    矯形外科、骨科器械
行業分類:	YY    醫藥行業標準
ICS分類:	11.040.40 11.040.40    外科植入物、假體和矯形 11.040.40
發布機構:	國家食品藥品監督管理總局
發布日期:	2016-01-26
實施日期:	2018-1-1
標準狀態:	valid
替代舊標準:	YY 0502-2005 膝關節假體
翻譯語言:	英文
文件格式:	PDF
中文字符數:	21000 字
翻譯價格(元):	400.0
交付時間:	付款后 1 個工作日

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