YY 0502-2016 PDF English
US$155.00 · In stock · Download in 9 secondsYY 0502-2016: Joint Replacement Implants - Knee Joint Prostheses Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY 0502: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0502-2016 | English | 155 |
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Joint Replacement Implants - Knee Joint Prostheses
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| YY 0502-2005 | English | 105 |
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Knee joint prostheses
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Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY 0502-2016
YY 0502-2016: Joint Replacement Implants - Knee 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/YY0502-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
C 35
Replacing YY 0502-2005
Joint Replacement Implants – Knee Joint Prostheses
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
Foreword
The Sub-clause 8.6.3 in this Standard is recommended, while the rest are
mandatory.
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaced YY 0502-2005 Knee Joint Prostheses; compared with YY
0502-2005, this Standard has the major technical differences as follows.
--- Add evaluation of oxidation stability and morphology of UHMWPE materials (see
7.3.1 of this Edition);
--- Add requirements for extensively radiation-cross-linked UHMWPE (see 7.3.2 of
this Edition);
--- Add plasma sprayed metal coating (see 7.5.2 of this Edition);
--- Modify the applicable scope of the surface defects (see 8.3 of this Edition; 6.2.2
of Edition 2005);
--- Modify the minimum thickness of UHMWPE component without tibial tray (see
8.5.2 of this Edition; 6.2.4.2 of Edition 2005);
--- Add dynamic mechanical properties (see 8.6 of this Edition);
--- Add requirements for relative angular motion range (see 8.7 of this Edition);
--- Delete inspection rules (see Clause 8 of Edition 2005).
Please note some contents of this document may involve the patents. The issuing
agency of this document doesn’t assume the responsibility to identify these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of Subcommittee on Orthopedics Implants
of National Technical Committee for Standardization of Surgery Implants and
Orthopedic Device (SAC/TC 110/SC 1).
Drafting organizations of this Standard. Tianjin Medical Device Quality Supervision and
Testing Center, Smith & Nephew Orthopedics (Beijing) Co., Ltd., and Beijing Baimtech
Materials Co., Ltd.
Chief drafting staffs of this Standard. Ma Chunbao, Jiao Yongzhe, Cheng Buyuan,
Liang Fanghui, Fan Bo, Song Duo, Qi Baofen, and He Juan.
This Standard was first-time published in December 2005.
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
3 Terms and Definitions
The following terms and definitions and those ones stipulated in YY/T 0919, YY/T
0924.1 and ISO 21534 are applicable to this document.
3.1 Conventional UHMWPE
The UHMWPE manufactured by mold pressing or extrusion molding, without cross-
linked treatment prior to the final sterilization.
4 Classification and Dimension Marking
4.1 Classification
It shall meet the requirements of YY/T 0924.1.
5 Expected Performance
It shall meet the requirements of YY/T 0919.
6 Design Attributes
It shall meet the requirements of YY/T 0919.
7 Materials
7.1 General
The requirements in YY/T 0919 and the following contents are applicable to this
Standard.
7.2 Metallic materials
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.
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
7.5.2.3 Mechanical properties
7.5.2.3.1 Perform the shear fatigue test of coatings as per the test method in ASTM
F1160; the test at specified shear fatigue strength shall at least finish 107 times cycles.
7.5.2.3.2 When testing as per the test method given in ASTM F1044, the shear
strength between coating and matrix shall reach 20MPa above.
7.5.2.3.3 When testing as per the test method given in ASTM F1147, the tensile
strength between coating and matrix shall reach 22MPa above.
8 Design Evaluation
8.1 General
The requirements of YY/T 0919 and the following contents are applicable to this
Standard.
8.2 Appearance
8.2.3 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.
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.
8.5 Dimensions and tolerances on important positions
8.5.1 The dimension marking shall be performed as per the requirements of YY/T
0924.1; the manufacturer shall specify the dimension and tolerance range of the
corresponding product; the inspection of dimension and tolerance on each position
shall be tested with general measuring tool, special inspecting tool or measuring
instrument.
8.6 Dynamic performance
8.6.1 Test principles
When testing the dynamic performance, the worst case (for instance, the stress level
is largest, and wearing degree is most serious) in the same serial prostheses shall be
tested correspondingly. The evaluation of worst case shall be performed with
combination of product expected performance and design attributes by the finite
element analysis and other inspection method.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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