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YY 0118-2016 PDF English

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YY 0118-2016: Joint replacement implants - Hip joint prostheses
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YY 0118: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY 0118-2016English145 Add to Cart 0-9 seconds. Auto-delivery Joint replacement implants - Hip joint prostheses Valid
YY 0118-2005English105 Add to Cart 0-9 seconds. Auto-delivery Hip joint prostheses Obsolete
YY 0118-1993English639 Add to Cart 5 days (Hip prosthesis) Obsolete

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YY/T 0119.1   YY/T 0119.4   YY 0117.2   

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

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0118-2016
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.40 C 35 Replacing YY 0118-2005 Joint Replacement Implants – Hip Joint Prostheses 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. This Standard was proposed by the China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China, Bone Implants Technical Sub Committee (SAC/TC 110/SC 1). Drafting organizations of this Standard. Tianjing Medical Device Quality Supervision and Testing Center, Baimtec Material Co., Ltd., Smith & Nephew Orthopaedics (Beijing) Co., Ltd., and Center for MD Evaluation SFDA. Chief drafting staffs of this Standard. Jiao Yongzhe, Ma Chunbao, Liang Fanghui, Cheng Buyuan, Shi Xinli, Liu Bin, Fan You,.Song Feng, Qi Baofen, and Zhao Geji. The historical edition replaced by this Standard is as follows. --- YY 0118-1993, YY 0118-2005. 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

3 Terms and Definitions

The following terms and definitions defined in YY/T 0809.1, YY/T 0920, and ISO 21534 are applicable to this document. 3.1 Conventional UHMWPE UHMWPE manufactured through molding or extrusion forming, undergone no cross-linked treatment before the final sterilization.

4 Classification and Size Marking

4.1 Classification It shall conform to the requirements of YY/T 0809.1.

5 Expected Performance

It shall conform to the requirements of YY/T 0920.

6 Design Attributes

It shall conform to the requirements of YY/T 0920.

7 Materials

7.1 General It shall conform to the requirements of YY/T 0920. 7.2 Metal materials 7.2.1 Chemical composition of metal materials manufactured hip joint prostheses shall conform to the provisions of corresponding standard. 7.2.2 Microstructure of forging and machining materials shall conform to the provisions of corresponding standard. 7.3 UHMWPE materials 7.3.1 Physical properties of conventional UHMWPE materials manufactured hip joint prostheses shall conform to the provision of GB/T 19701.2, impurity element content shall conform to the provision of GB/T 19701.1.Manufacturer shall evaluate the oxidation stability (oxidation index and mechanical properties before and after aging) and morphology against the UHMWPE materials as per the method specified in YY/T 0772.3 ~ YY/T 0772.5. 7.4 Ceramic materials Physical and Chemical properties of ceramic materials manufactured hip joint prostheses shall conform to the provision of ISO 6474-1, ISO 6474-2, or ISO 13356. 7.5 Coating materials 7.5.1 Hydroxyapatite coating Hydroxyapatite coating of hip joint prostheses shall conform to the provision of GB 23101.2.

8 Design Evaluation

8.1 General It shall conform to the requirements of YY/T 0920 and the following requirements. 8.2 Appearance 8.2.1 Metal surface When implement visual inspection with normal and corrected vision, the metal part surface shall not have the defects that may influence the parts, such as oxide scales, knife marks, small gaps, scratches, cracks, dents,, burrs, and etc. nether there shall be final processing deposits nor other pollutants. 8.3 Surface defects When test as per the method specified in YY/T 0343, the surface of non-coated metal parts and ceramic components shall not have discontinuous defects. 8.4 Surface roughness 8.4.1 Articulating surface roughness 8.4.2 Tapered joint surface roughness Manufacturer shall specify the requirements of tapered joint surface roughness Ra and/or Rz, which shall be tested as per the method specified in GB/T 10610. 8.4.3 Coating surface roughness Manufacturer shall specify the requirements of coating surface roughness Ra or Rz, which shall be tested as per the method specified in GB/T 10610. 8.5 Dimensions and tolerances of important parts Test of each part’s dimension and tolerance is implemented through the measuring tool, special gages or measuring instrument, while spherical roundness radial deviation of articulating surface shall be carried out as per the provision in YY/T 0809.2. 8.5.1 Dimension and tolerance of tapered connection Manufacturer shall specify the dimension and tolerance of diameter, cone skin, straightness and roundness at least. 8.5.2 Dimension and tolerance of articulating surface 8.6 Static mechanical properties 8.6.1 Femoral fixed anti-torque performance measurement of stemmed femoral components It shall be carried out as per the method specified in ISO 7206-10. 8.6.3 Metal acetabular resistance to deformation Note. Relevant standard of test method is under preparation, which shall be implemented after the publication. 8.7 Dynamic performance 8.8 Minimum and maximum angles It shall conform to the requirements of minimum and maximum angles specified in YY/T 0920.

9 Manufacture

It shall conform to the requirements specified in YY/T 0920.

10 Sterilization

10.1 General Requirements from YY/T 0920, and the following contents are applicable to this standard. 10.2 Product supplied in sterile state As for product supplied in sterile state, the sterilization process shall be effective and be carried out as per the convention. Note. GB/T 14233.2 specifies the sterile test method, but such method can’t prove the effectiveness of the sterilization process. The sterilization process can refer to GB 18278 ~ GB 18280.

11 Package

It shall conform to the requirements specified in YY/T 0920.

12 Information Provided by Manufacturer

It shall conform to the requirements specified in YY/T 0920. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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