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YY 0502-2016 English PDF (YY0502-2016)

YY 0502-2016 English PDF (YY0502-2016)

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YY 0502-2016: Joint replacement implants - Knee joint prostheses

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.
YY 0502-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0502-2005
Joint Replacement Implants ?€? Knee Joint Prostheses
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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 0.1??m.
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 2??m. 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...

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