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YY 0502-2016 English PDF (YY 0502-2005)

YY 0502-2016_English: PDF (YY0502-2016)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0502-2016English155 Add to Cart 0--9 seconds. Auto-delivery Joint replacement implants - Knee joint prostheses Valid YY 0502-2016
YY 0502-2005English105 Add to Cart 0--9 seconds. Auto-delivery Knee joint prostheses Obsolete YY 0502-2005


BASIC DATA
Standard ID YY 0502-2016 (YY0502-2016)
Description (Translated English) Joint replacement implants. Knee joint prostheses
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 14,181
Date of Issue 1/26/2016
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0502-2005
Quoted Standard GB/T 10610; GB/T 14233.1; GB/T 14233.2; GB/T 16886.7; GB 18278; GB 18279; GB 18280; GB/T 19701.1; GB/T 19701.2; GB 23101.2; YY 0117.1; YY 0117.2; YY 0117.3; YY/T 0343; YY/T 0772.3; YY/T 0772.4; YY/T 0772.5; YY/T 0810.1; YY/T 0919; YY/T 0924.1; YY/T 0924.2; ISO 6474-1; ISO 6474
Drafting Organization Tianjin Medical Device Quality Supervision and Inspection Center, Shi Lehui Surgical Implants (Beijing) Co., Ltd., Beijing 100 Screen Aviation Materials High Technology Co., Ltd.
Administrative Organization National Technical Committee on Orthopedic Implants for Orthopedic Implants and Orthopedic Devices Technical Committee (SAC/TC 110/SC 1)
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the terms and definitions, classification and dimensioning, expected properties, design properties, materials, design evaluation, manufacturing, sterilization, packaging, and information requirements of the manufacturer of knee prostheses. This standard applies to partial and total knee prostheses made using the materials and processes specified in this standard.

BASIC DATA
Standard ID YY 0502-2005 (YY0502-2005)
Description (Translated English) Knee joint prostheses
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 22,238
Date of Issue 2005-12-07
Date of Implementation 2006-12-01
Quoted Standard GB/T 2828.1; GB/T 2829; GB/T 14233.1; GB/T 14233.2; GB/T 16886.7; GB/T 19701.2; GB/T 19633; YY 0117-2005; YY 0341; YY 0343; HB/Z 60; ISO 7207-1; ISO 7207-2; ISO 13779-3
Adopted Standard ISO 14630-1997, NEQ; ISO 21534-2002, NEQ; ISO 21536-2002, NEQ; ISO 7207-1-1994, NEQ; ISO/FDIS 7207-2-1998, NE
Drafting Organization Beijing Air Materiel Bermuda tech stock company
Administrative Organization National standardization technical committee of Surgical characters and orthopedic implant device
Regulation (derived from) Industry Standard Notice 2006 No. 2 (No. 74 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the knee prosthesis definition, classification, expected performance, requirements, test methods, inspection rules, marking, manual, packaging, transportation and storage requirements. This standard applies to the human body part or all of the purposes of the passive knee replacement surgical implants.


YY 0502-2016 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.40 C 35 Replacing YY 0502-2005 Joint Replacement Implants – Knee Joint Prostheses 关节置换植入物 膝关节假体 ISSUED ON. JANUARY 26, 2016 IMPLEMENTED ON. JANUARY 01, 2018 Issued by. China Food and Drug Administration Table of Contents Foreword . 3 1 Scope .. 4 2 Normative References . 4 3 Terms and Definitions . 7 4 Classification and Dimension Marking . 7 5 Expected Performance . 7 6 Design Attributes .. 7 7 Materials . 7 8 Design Evaluation . 10 9 Manufacture . 12 10 Sterilization . 12 11 Package . 13 12 Information Provided by the Manufacturer .. 13 Appendix A (Normative) Approved Material Standard List on Manufacturing the Knee Joint Prostheses . 14 Appendix B (Normative) Approved and Non-Approved Material List on Manufacturing Articular Surface of Knee Joint Prostheses .. 16 Appendix C (Normative) Approved and Non-Approved Metal Combination List on Non-Articular Contact Surface of Knee Joint Prostheses . 18 Appendix D (Normative) Approved Standard List for Chemical Analysis Method . 19 Joint Replacement Implants – Knee Joint Prostheses 1 Scope This Standard specifies the requirements for terms and definitions, classification and dimension marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, package, and information provided by the manufacturer of the knee joint prostheses. This Standard is applicable to partial or total knee joint prostheses manufactured by the materials and processes specified in this Standard. 2 Normative References The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document. 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 Equipment 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 - Requirement 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 Form 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-Cross-linked 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, Definition and Designation of Dimensions YY/T 0924.2 Implants for Surgery – Components for Partial and Total Knee Joint Prostheses – Part 2. Articulating Surface Made of Metal, Ceramic and Plastic Materials ISO 6474-1 Implants for Surgery – Ceramic Materials – Part 1. Ceramic Materials Based on High Purity Alumina 7.2 Metallic materials 7.2.1 The chemical composition of the metallic materials used for manufacturing the knee joint prostheses shall conform to the provisions of corresponding standard. 7.2.2 The microstructure of the forgings shall conform to the provisions of corresponding standard. 7.2.3 The mechanical properties shall conform to the provisions of corresponding standard. 7.2.4 The internal quality of the castings shall conform to the provisions of corresponding standard. NOTE. when the material of knee joint prostheses adopts Ti6Al4V titanium alloy forgings, ZTi6Al4V titanium alloy castings, cobalt chromium molybdenum alloy castings, its chemical compositions, mechanical properties, the microstructure of the forgings, the internal quality of the castings shall conform to the provisions of YY0117.1~0117.3. 7.3 UHMWPE material 7.3.1 The physical properties of conventional UHMWPE material used for manufacturing the knee joint prostheses shall conform to the provisions of GB/T 19701.2; the content of impurity elements shall conform to the provisions of GB/T19701.1. The manufacturers shall evaluate the oxidative stability (e.g.. oxidation index and mechanical properties before and after aging) and morphology of the conventional UHMWPE material according to the method given in YY/T 0772.3~YY 0772.5. 7.3.2 The manufacturer shall specify the performance index of extensively radiation- cross-linked UHMWPE material according to the requirements of YY/T 0811. 7.4 Ceramic material The physical and chemical properties of ceramic material used for manufacturing knee joint prostheses shall conform to the provisions of ISO 6474-1, ISO 6474-2 or ISO 13356. 7.5 Coating material 7.5.1 Hydroxyapatite coating The hydroxyapatite coating for knee joint prostheses shall conform to the provisions of GB 23101.2. 7.5.2 Plasma sprayed metallic coating 8 Design Evaluation 8.1 General The requirements of YY/T 0919 and the following contents are applicable to this Standard. 8.2 Appearance 8.2.1 Metallic surface When visually examining with normal or corrected vision, the metal part surface of knee joint prostheses shall be free of oxide scales, knife marks, small gaps, scratches, cracks, depressions, traps, sharp edges, burrs, and other defects; the surface shall also be free of inlays, final processed deposits and other contaminants. NOTE. for the metal parts with coatings, the manufacturer shall specify the requirements of coating surface quality. 8.2.2 Plastic surface When visually examining with normal or corrected vision, the articular surface of the plastic parts of the knee joint prostheses shall be free from particulate contamination. 8.2.3 Ceramic surface When visually examining with normal or corrected vision, the articular surface of the ceramic parts of knee joint prostheses shall be free of particulate contamination, spot- like or larger chemical color change, knife marks, small gaps, debris, depressions, cracks and the like defects. 8.3 Surface defects When testing as per the test method given in YY/T 0343, the surface of the uncoated metal parts and the surface of ceramic parts shall be free of discontinuous defects. NOTE. for the metal parts with coatings, the manufacturer shall perform surface defect inspection of the product before coating. 8.4 Surface roughness 8.4.1 The articular surface roughness Ra value of partial or full knee joint prostheses metal or ceramic femoral components shall be no greater than 0.1µm. 8.4.2 The articular surface roughness Ra value of particular or full knee joint prostheses plastic tibial and patellar components shall be no greater than 2µm. NOTE. The tibial tray test method in YY/T 0810.1 is a simplified method to evaluate the performance and modelling part rather than all clinical failure modes. Minimum performance level of 900N is determined as per the literature and t he experience of several test institutes. Some researchers have used other test methods to evaluate similar or different failure modes of the full knee joint tibial components; their practice is also recognized. 8.6.3 Wear test for full knee replacement (recommended) The wear characteristics of full knee replacement consisting of metal or ceramic femoral components or tibial components shall be tested as per ISO 14243-1, ISO 14243-2 and ISO 14243-3. 8.7 Relative angular motion range The relative angular motion range between femoral component and tibial component shall be tested as per the provisions of ISO 21534; YY/T 0919 gives an applicable method for measuring the range of motion of a fully constrained knee joint. 9 Manufacture It shall meet the requirements of YY/T 0919. 10 Sterilization 10.1 General The requirements of YY/T 0919 and the following contents are applicable to this Standard. 10.2 Products supplied in sterilized state For the products supplied in sterilized state, the sterilization process shall be effective and routinely controlled. NOTE. GB/T 14233.2 specifies a sterility test method; but this method can’t prove the effectiv... ......


YY 0502-2005 YY ICS 11.040.40 C 35 Pharmaceutical Industry Standard of the People’s Republic of China Knee Joint Prostheses 膝关节假体 ISSUED ON. DECEMBER 7, 2005 IMPLEMENTED ON. DECEMBER 1, 2006 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Terms and definitions ... 5  4 Classification, dimensions and schematic diagrams ... 9  5 Intended performance ... 16  6 Requirements ... 17  7 Test methods ... 20  8 Inspection rules ... 21  9 Packaging ... 23  10 Information provided by the manufacturer ... 23  11 Transportation and storage ... 26  Annex A ... 27  Annex B ... 29  Annex C ... 31  Bibliography ... 33  Foreword This Standard was prepared by reference to relevant contents of international standards ISO 14630.1997 "Non-active Surgical Implants - General Requirements", ISO 21534.2002 "Non-active Surgical Implants - Joint Replacement Implants - Particular Requirements", ISO 21536.2002 "Non-active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee-Joint Replacement Implants", ISO 7207-1.1994 "Implants for Surgery - Femoral and Tibial Components for Partial and Total Knee Joint Prostheses", and ISO /FDIS 7207-2.1998 "Implants for Surgery - Femoral and Tibial Components for Partial and Total Knee Joint Prostheses - Part 2. Articulating Surfaces Made of Metal, Ceramic and Plastics Materials". This Standard was proposed by the China Food and Drug Administration. This Standard shall be under the jurisdiction of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China (SAC/TC 110). Drafting organization of this Standard. Beijing Baimtec Material Co., Ltd. Main drafters of this Standard. Huang Yongling, Sun Jianwen, and Cui Jian. Knee Joint Prostheses 1 Scope  This Standard specifies the definitions, classification, intended performance, requirements, test methods, inspection rules, marking, instructions for use, packaging, transportation, and storage of knee joint prostheses. This Standard is applicable to non-active surgical implants that replace partial or full knee joint of human body. 2 Normative references  The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 2828.1 Sampling Procedures for Inspection by Attributes - Part 1. Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection (GB/T 2828.1-2003, ISO 2859-1.1999, IDT) GB/T 2829 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection of Process Stability) GB/T 14233.1 Test Methods for Infusion, Transfusion, Injection Equipment 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/T 16886.7-2001, ISO 10993-7.1995, IDT) GB/T 19701.2 Implants for Surgery - Ultrahigh Molecular Weight Polyethylene - Part 2. Moulded Forms (ISO 5834-2, IDT) GB/T 19633 Packaging for Terminally Sterilized Medical Devices (GB/T 19633-2005, ISO 11607.2003, IDT) YY 0117-2005 (all the parts) Implants for Surgery - Forgings, Castings for Bone Joint Prostheses YY 0341 General Technological Requirements for Non-active Metallic Surgery Implants of Osteosynthesis YY 0343 Liquid Penetrant Inspection of Metallic Surgical Implants (ISO 9583, NEQ) HB/Z 60 Instructions for X-ray Examination ISO 7207-1 Implants for Surgery - Femoral and Tibial Components for Partial and Total Knee Joint Prostheses - Part 1. Classification, Definitions and Designation of Dimensions ISO 7207-2 Implants for Surgery - Femoral and Tibial Components for Partial and Total Knee Joint Prostheses - Part 2. Articulating Surfaces Made of Metal, Ceramic and Plastics Materials ISO 13779-2 Implants for Surgery - Hydroxyapatite - Part 2. Coatings of Hydroxyapatite ISO 14630 Non-active Surgical Implants - General Requirements ISO 21534 Non-active Surgical Implants - Joint Replacement Implants - Particular Requirements ISO 21536 Non-active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee-Joint Replacement Implants ISO 6474 Implants for Surgery - Ceramic Materials Based on High Purity Alumina ISO 13356 Implants for Surgery - Ceramic Materials Based on Yttria-stabilized Tetragonal Zirconia 3 Terms and definitions  The following terms and definitions apply to this Standard. 3.1 Unicompartmental knee joint prostheses Knee joint prostheses that is designed to replace the femoral and tibial bearing surfaces in one compartment of the knee. 3.2 Partial unicompartmental knee joint component Knee joint prostheses that is designed to replace the bearing surface of one condyle OF either the femur or the tibia (See Figure 1, position A, B, C or D). 3.3 Partial bicompartmental knee joint component Knee joint prostheses that is designed to replace the bearing surfaces of both condyles OF either the femur or the tibia (See Figure 1, positions A and B, or C and D). Note 1. In surgical practice, unicondylar components can be used either for unicondylar replacements, for partial replacements, or for total replacements; whereas generally bicondylar components are used only for total knee joint replacement. 3.4 Unicompartmental knee joint replacement Procedure of replacing the bearing surfaces of the contiguous condyles of the femur and tibia in one compartment of the knee (See Figure 1, positions A and C, or B and D). 3.5 Total replacement of the knee joint Procedure of replacing the femoral and tibial bearing surfaces in both compartments of the knee (See Figure 1, positions A, B, C and D). Note 2. Patella attachment device may or may not be provided. 3.6 Non-constrained total knee joint prostheses Total knee joint prostheses in which there is no mechanical attachment between the tibial and femoral components, and which allows movement in all three planes (see figures 2, 3, and 4). 3.7 Partially-constrained total knee joint prostheses Total knee joint prostheses that have some mechanical constraint between the tibial and femoral components, and which allows movement in more than one plane (see Figure 5). 3.8 Fully-constrained total knee joint prostheses Total knee joint prostheses in which the two parts are mechanically articulated and which allows movement principally in one plane (see Figure 6). 3.9 Effective bone resection distance Minimum distance between resected surfaces of the femur and/or tibia in contact with the plateau of the implant. 3.10 Stem The part of bicondylar component that enters into the medullary cavity (see figures 2, 5, and 6, dimensions t and f). 3.11 Femoral stem angle Acute angle BETWEEN the axis of the femoral stem AND the normal of installation plateau, as viewed from the front-back direction. Note 3. The direction of this angle determines whether the prostheses is used in the right or left leg of the patient. 3.12 Tibial stem angle Angle BETWEEN the axis of the tibial stem AND the normal of installation plateau, as viewed from the front-back direction. 3.13 Intracondylar projection The part that is used to position and fix the condylar component in the condyle (see Figures 3 and 4, dimensions tp and fp). 3.14 Overall width The maximum dimension between two planes (see figures 2 to 5, dimension w). 3.15 Tibial tray The sub-component that is used to support and secure the articulating sub-component of a tibial component of a unicompartmental or total knee joint prostheses. 3.23 Patella component Component of a total or partial knee joint replacement which is used to replace the articulating surface of the patella. 3.24 Patella tray The sub-component that is used to support and secure the articulating sub-component of a patella component. 3.25 Meniscal component The component ... ......

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