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YY/T 0810.1-2010 English PDF (YY/T0810.1-2010)
YY/T 0810.1-2010 English PDF (YY/T0810.1-2010)
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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
Implants for surgery.Total knee joint prostheses.Part 1. Determination of endurance properties of knee tibial trays
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Surgical implants in total knee prosthesis
Part 1. Determination of fatigue properties of the tibial tray
Part 1. Determinationofendurancepropertiesofkneetibialtrays
(ISO 14879-1.2000, IDT)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0810 "surgical implants for total knee prosthesis" is expected to be divided into the following sections.
--- Part 1. Determination of the tibial tray fatigue properties;
--- Part 2 .( reserve).
This section YY/T Section 10810 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 14879-1.2000 "surgical implants in total knee prostheses - Part 1. tibial tray tired
Determination of labor performance. "
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC /
TC110/SC1) centralized.
This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Beijing Air Materiel Biam tech
CO., LTD.
The main drafters of this section. Jiaoyong Zhe, Wang Haiyan Jo, Dong Shuangpeng, Houbao Yi, Liang Fanghui.
Surgical implants in total knee prosthesis
Part 1. Determination of fatigue properties of the tibial tray
1 Scope
YY/T 0810 This section provides detailed under certain laboratory conditions, the determination of the knee prosthesis support and protect the articular surface of the plastic
Test methods for fatigue properties of the tibial tray. This test method is suitable for covering the lateral tibial tibial tray.
This test method is not applicable to the tibial component with only a plastic material.
This part of the test sample and reporting the final state is not involved. These content providers negotiated by the testing laboratory and the sample.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 4965. 1979 Axial load fatigue testing machine dynamic force calibration strain measurement technology (Axialloadfatiguetesting
machines-Dynamicforcecalibration-Straingaugetechnique)
ISO 7207-1.1994 Part 1 of the femoral and tibial components Implants and total knee prosthesis. classifications, definitions
And dimension (Implantsforsurgery-Componentsforpartialandtotalknee-jointprostheses-Part 1.
Classification, definitionanddesignationofdimensions)
3 Terms and Definitions
As defined in ISO 7207-1 and the following terms and definitions apply to this document.
3.1
Before and after the midline anteroposteriorcentreline
After the tibial tray and the center line parallel to the sagittal plane.
3.2
The side of the midline mediolateralcentreline
After the center of the tibial tray and a straight line parallel to the coronal or frontal plane.
3.3
Arm momentarm
dml
The vertical distance between the center line and load is applied to the axis of the front and rear tibial component.
NOTE. If you load point after the midline, the distance is positive.
3.4
Arm momentarm
dap
The vertical distance between the side and the middle load is applied between the axes of the tibial component.
Principle 4
Sample fixed on the test equipment, so that a condyle of the tibial tray is cantilevered structure. Through an ultrahigh molecular weight polyethylene
Get Quotation: Click YY/T 0810.1-2010 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 0810.1-2010
Preview True-PDF (Reload/Scroll-down if blank)
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
Implants for surgery.Total knee joint prostheses.Part 1. Determination of endurance properties of knee tibial trays
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Surgical implants in total knee prosthesis
Part 1. Determination of fatigue properties of the tibial tray
Part 1. Determinationofendurancepropertiesofkneetibialtrays
(ISO 14879-1.2000, IDT)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0810 "surgical implants for total knee prosthesis" is expected to be divided into the following sections.
--- Part 1. Determination of the tibial tray fatigue properties;
--- Part 2 .( reserve).
This section YY/T Section 10810 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 14879-1.2000 "surgical implants in total knee prostheses - Part 1. tibial tray tired
Determination of labor performance. "
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC /
TC110/SC1) centralized.
This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Beijing Air Materiel Biam tech
CO., LTD.
The main drafters of this section. Jiaoyong Zhe, Wang Haiyan Jo, Dong Shuangpeng, Houbao Yi, Liang Fanghui.
Surgical implants in total knee prosthesis
Part 1. Determination of fatigue properties of the tibial tray
1 Scope
YY/T 0810 This section provides detailed under certain laboratory conditions, the determination of the knee prosthesis support and protect the articular surface of the plastic
Test methods for fatigue properties of the tibial tray. This test method is suitable for covering the lateral tibial tibial tray.
This test method is not applicable to the tibial component with only a plastic material.
This part of the test sample and reporting the final state is not involved. These content providers negotiated by the testing laboratory and the sample.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 4965. 1979 Axial load fatigue testing machine dynamic force calibration strain measurement technology (Axialloadfatiguetesting
machines-Dynamicforcecalibration-Straingaugetechnique)
ISO 7207-1.1994 Part 1 of the femoral and tibial components Implants and total knee prosthesis. classifications, definitions
And dimension (Implantsforsurgery-Componentsforpartialandtotalknee-jointprostheses-Part 1.
Classification, definitionanddesignationofdimensions)
3 Terms and Definitions
As defined in ISO 7207-1 and the following terms and definitions apply to this document.
3.1
Before and after the midline anteroposteriorcentreline
After the tibial tray and the center line parallel to the sagittal plane.
3.2
The side of the midline mediolateralcentreline
After the center of the tibial tray and a straight line parallel to the coronal or frontal plane.
3.3
Arm momentarm
dml
The vertical distance between the center line and load is applied to the axis of the front and rear tibial component.
NOTE. If you load point after the midline, the distance is positive.
3.4
Arm momentarm
dap
The vertical distance between the side and the middle load is applied between the axes of the tibial component.
Principle 4
Sample fixed on the test equipment, so that a condyle of the tibial tray is cantilevered structure. Through an ultrahigh molecular weight polyethylene
