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YY/T 0810.1-2010 English PDF (YYT0810.1-2010)

YY/T 0810.1-2010 English PDF (YYT0810.1-2010)

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YY/T 0810.1-2010: Implants for surgery. Total knee joint prostheses. Part 1: Determination of endurance properties of knee tibial trays

YY/T 0810.1-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
YY/T 0810.1-2010 / ISO 14879-1:2000
Implants for surgery - Total knee-joint prostheses - Part 1:
Determination of endurance properties of knee tibial trays
外科植入物 全膝关节假体
(ISO 14879-1:2000, IDT)
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Principle ... 5
5 Apparatus ... 5
6 Procedure ... 8
7 Test report ... 9
8 Disposal of test specimens ... 10
Bibliography ... 11
Foreword
YY/T 0810 "Implants for surgery - Total knee-joint prostheses" is expected to be divided into the following parts:
- Part 1: Determination of endurance properties of knee tibial trays;
- Part 2: (Reserved).
This Part is Part 1 of YY/T 0810.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009. This Part, using translation method, is identical to ISO 14879-1:2000 "Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays".
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority of this document shall not be held responsible for identifying any or all such patent rights.
This Part shall be under the jurisdiction of Subcommittee 1 on Materials and Orthopedic Implants, National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China (SAC/TC 110/SC 1).
Drafting organizations of this Part: Tianjin Medical Devices Quality Supervision and Testing Center, China Food and Drug Administration; Baimtec Material Co., Ltd. Main drafters of this Part: Jiao Yongzhe, Wang Zuoyan, Dong Shuangpeng, Hou Baoyi, Liang Fanghui.
Implants for surgery - Total knee-joint prostheses - Part 1:
Determination of endurance properties of knee tibial trays
1 Scope
This Part of YY/T 0810 specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastics articulating surface. This test method applies to tibial trays which cover both the medial and lateral plateaux of the tibia.
The test method does not apply to tibial components manufactured solely from plastics materials.
This Part does not cover methods of examining and reporting the final condition of the test specimen; these may be the subject of agreement between the test laboratory and the parties submitting the specimen for test.
2 Normative references
The following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.
ISO 4965:1979 Axial load fatigue testing machines - Dynamic force calibration - Strain gauge technique
ISO 7207-1:1994 Implants for surgery - Components for partial and total knee-joint prostheses - Part 1: Classification, definitions and designation of dimensions 3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7207-1 apply, together with the following.
3.1
Anteroposterior centreline
Line which passes through the centre of the tibial tray, parallel to the sagittal. tibial tray design being tested, but any deviations from these specified dimensions shall be included in the test report.
Note: Material in accordance with grade 1 or grade 2 of GB/T 19701.2 has been found suitable. 5.4 Load applicator, a rod of diameter 32 mm ± 1 mm with a spherical indentor end. It is recommended that the indentor be manufactured from a steel or cobalt-chrome alloy.
Note: The load applicator may be modified to accommodate aspects of the tray design, such as a rim around the periphery.
6 Procedure
6.1 Determine the overall mediolateral and anteroposterior dimensions in accordance with ISO 7207-1:1994, Figures 2 and 3.
6.2 Fix the test specimen in accordance with 5.2 c). If the test specimen is asymmetrical, ensure that it is fixed so that the bending moment is a maximum at the junction of the tray with the stem, or at the division between the medial and lateral compartments if no stem is present. Ensure that there is a clearance of at least 5 mm between the undersurface of the loaded compartment on the tibial tray and any part of the fixture. Ensure that the loaded part of the tibial tray does not make contact with any part of the fixture during testing.
6.3 Position the test specimen so that the load axis is perpendicular to the undeflected superior surface of the tray.
Note 1: The tray surface will not remain perpendicular to the load axis during loading. Note 2: The loading point will be located at a distance dml from the anteroposterior and dap from the mediolateral centreline in the position where it is expected to be loaded in vivo at 0° flexion. 6.4 Use one of the following methods to determine the position of the loading point. a) For biconcave tibial designs, the loading point shall be at the intersection with the tray of a line drawn normal to the tray which intersects the deepest part of the recess in the articular surface.
b) For other tibial components, the femoral component, the tibial articulating surface component and the tibial tray shall be assembled at 0° flexion and the position of the centre of pressure determined. The centre of pressure shall be on the line perpendicular to the tray which passes through the loading point.
Note: The position of the centre of pressure may be determined using pressure-sensitive film,

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