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YY 0118-2016 English PDF (YY0118-2016)

YY 0118-2016 English PDF (YY0118-2016)

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YY 0118-2016: Joint replacement implants - Hip joint prostheses

This Standard specifies the terms and definitions, classification and size marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, packing, and manufacturer information requirements for the total-hip and partial-hip joint prostheses.
YY 0118-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0118-2005
Joint Replacement Implants ?€?
Hip Joint Prostheses
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ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 8
4 Classification and Size Marking ... 8
5 Expected Performance ... 8
6 Design Attributes ... 8
7 Materials ... 8
8 Design Evaluation ... 11
9 Manufacture ... 15
10 Sterilization ... 15
11 Package ... 16
12 Information Provided by Manufacturer ... 16
Appendix A ... 17
Appendix B ... 19
Appendix C ... 21
Appendix D ... 23
Foreword
Clause 7.7.4 of this Standard is recommendatory, while the rest are mandatory. This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaces YY 0118-2005 Hip Joint Prostheses. Compared with YY 0118-2005, the main changes in this Standard are as follows.
--- Add the oxidation stability and morphological evaluation of ultrahigh molecular weight polyethylene (see Clause 7.3.1 of this version);
--- Add the requirements for extensively radiation cross-linked ultrahigh molecular weight polyethylene (see Clause 7.3.2 of this version);
--- Add the requirements for plasma spraying metal coating (see Clause 7.5.2 of this version);
--- Modify the applicable scope of surface defects (see Clause 8.3 of this version; and Clause 4.2.2 of Version 2005);
--- Add femoral head fixed anti-torque performance measurement against the stemmed femoral component (see Clause 8.6.1 of this version);
--- Add the combined femoral head anti-static load force (see Clause 8.6.2 of this version);
--- Add metal acetabular resistance to deformation (see Clause 8.6.3 of this version);
--- Modify the shank fatigue performance of stemmed femoral components, and amending it as mandatory clause (see Clause 8.7.2 of this version; and Clause 5.3.1 of Version 2005);
--- Modify the head and neck fatigue performance of stemmed femoral components, and amending it as mandatory clause (see Clause 8.7.3 of this version; and Clause 5.3.2 of Version 2005);
--- Add the maximum and minimum angles (see Clause 8.8 of this version); --- Delete the inspection rules in the original standard (see Chapter 7 of Version 2005).
Please note that some contents of this document may involve patents. The releasing organization of this document shall not assume the responsibility for identifying these patents.
Joint Replacement Implants - Hip Joint
Prostheses
1 Scope
This Standard specifies the terms and definitions, classification and size marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, packing, and manufacturer?€?s information requirements for the total-hip and partial-hip joint prostheses.
This Standard is applicable to manufacture total-hip and partial-hip joint prostheses used 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 standard.
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 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 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 0809.1 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1. Classification and Designation of Dimensions (YY/T 0809.1-2010, ISO
7206-1.2008, IDT)
YY/T 0809.2 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 2. Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials (YY/T 0809.2-2010, ISO 7206-2.1996, IDT)
YY/T 0811 Standard Guide for Extensively Irradiation - Crosslinked Ultrahigh Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications YY/T 0920 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants (YY/T 0920-2014, ISO
21535.2007, IDT)
ISO 4287 Geometrical Product Specification (GPS) - Surface Texture. Profile Method - Terms, Definitions and Surface Texture Parameters
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 7206-4 Implants for Surgery ?€? Partial and Total Hip Joint Prostheses ?€? Part 4. Determination of Endurance Properties of Stemmed Femoral Components
ISO 7206-6 Implants for Surgery ?€? Partial and Total Hip Joint Prostheses ?€? Part 6. Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components
ISO 7206-10 Implants for Surgery - Partial and Total Hip Joint Prostheses ?€? Part 10. Determination of Resistance to Static Load of Modular Femoral Heads
ISO 13356 Implants for Surgery ?€? Ceramic Materials Based on Yttria-Stablized Tetragonal Zirconia (Y-TZP)
ISO 14242-1 Implants for Surgery ?€? Wear of Total Hip-Joint Prostheses - Part 1. Loading and Displacement Parameters for Wear-Testing Machines Corresponding Environmental Conditions for Test
ISO 4242-2 Implants for Surgery ?€? Wear of Total Hip-Joint Prostheses ?€? Part 2. Methods of Measurement
ISO 4242-3 Implants for Surgery ?€? Wear of Total Hip-Joint prostheses - Part 3. Loading and Displacement Parameters for Orbital Bearing Type Wear Testing Machines and Corresponding Environmental Conditions for Test
ISO 14630 Non-Active Surgical Implants ?€? General Requirements
ISO 21534 Non-Active Surgery Implants ?€? Joint Replacement Implants ?€? particular Requirements
ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate
Coating and Metallic Coating
ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate Coating and Metallic Coating
ASTM F1160 Standard Test Method for Shear and Bending Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/metallic coating
ASTM F1377 Standard Specification for Cobalt-28Chromium-6Molybdenum Power for Coating of Orthopaedic Implants
ASTM F1580 Standard Specification for Titanium and
Titanium-6Aluminum-4Vanadium Alloy Powders for Coating of Surgical Implants ASTM F1854 Standard Test Method for Stereo-Logical Evaluation of Porous Coating on Medical Implants
ASTM F1978 Stand...

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