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YY 0118-2016

Chinese Standard: 'YY 0118-2016'
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Detail Information of YY 0118-2016; YY0118-2016
Description (Translated English): Joint replacement implants. Hip joint prostheses
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 15,158
Date of Issue: 1/26/2016
Date of Implementation: 2018-01-01
Older Standard (superseded by this standard): YY 0118-2005
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 0177.2; YY 0177.3; YY/T 0343; YY/T 0772.3; YY/T 0772.4; YY/T 0772.5; YY/T 0809.1; YY/T 0809.2; YY/T 0811; YY/T 0920; ISO 4287; ISO 6474-1
Drafting Organization: (Beijing) Co., Ltd., the State Food and Drug Administration Medical Device Technology Review Center (Beijing) Co., Ltd., Beijing Medical Device Quality Supervision and Inspection Center, Beijing 100 Screen Aviation Materials High-tech Co., Ltd., Shi Lehui Surgical Implants
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 of partial and total hip prostheses, the requirements for classification and dimensioning, expected performance, design properties, materials, design evaluation, manufacture, sterilization, packaging and information provided by the manufacturer. This standard applies to partial and total hip prostheses made using the materials and processes specified in this standard.

YY 0118-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0118-2005
Joint Replacement Implants –
Hip Joint Prostheses
关节置换植入物-髋关节假体
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 Requi......
Related standard:   YY/T 0119.1-2014  YY/T 0119.2-2014
   
 
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