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YY/T 0809.4-2018: Implants for surgery. Partial and total hip joint prostheses. Part 4: Determination of endurance properties and performance of stemmed femoral components
Status: Valid YY/T 0809.4: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0809.4-2018 | English | 284 |
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Implants for surgery. Partial and total hip joint prostheses. Part 4: Determination of endurance properties and performance of stemmed femoral components
| Valid |
YY/T 0809.4-2018
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| YY/T 0809.4-2010 | English | 519 |
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[Replaced by YY/T 0809.4-2018] Implants for surgery. Partial and total hip joint prostheses. Part 4: Determination of endurance properties of stemmed femoral components
| Obsolete |
YY/T 0809.4-2010
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PDF similar to YY/T 0809.4-2018
Basic data | Standard ID | YY/T 0809.4-2018 (YY/T0809.4-2018) | | Description (Translated English) | Implants for surgery. Partial and total hip joint prostheses. Part 4: Determination of endurance properties and performance of stemmed femoral components | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 15,179 | | Date of Issue | 2018-09-29 | | Date of Implementation | 2019-10-01 | | Older Standard (superseded by this standard) | YY/T 0809.4-2010 | | Quoted Standard | ISO 3696; ISO 4965; ISO 7206-1 | | Adopted Standard | ISO 7206-4-2010, IDT | | Regulation (derived from) | State Drug Administration Announcement No. 72 of 2018 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the test method for determining the fatigue performance of a shank femoral component in partial and total hip arthroplasty under specific test conditions. This section also specifies test conditions to consider important parameters affecting the test components and describes the method of installation of the test specimens. This section also specifies test parameters and femoral component fatigue limit requirements, including fatigue limit values ??and the corresponding number of load cycles. This section applies to prostheses with a symmetrical plane or prefabricated forward or double-sided shank. This part does not include the inspection method of the sample after the completion of the fatigue test. The content of this part is determined by the laboratory and the sample provider. For the fatigue test of the combined femoral component, a liquid test environment for the femoral component is specified. | YY/T 0809.4-2018: Implants for surgery. Partial and total hip joint prostheses. Part 4: Determination of endurance properties and performance of stemmed femoral components
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for surgery.Partial and total hip joint prostheses.Part 4. Determination of endurance properties and performance of stemmed femoral components
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0809.4-2010
Surgical implant part and total hip prosthesis
Part 4. Fatigue properties of femoral components with shank
Test and performance requirements
Part 4.Determinationofendurancepropertiesand
(ISO 7206-4.2010, IDT)
2018-09-28 released.2019-10-01 implementation
State Drug Administration issued
Foreword
YY/T 0809 "Surgical Implant Part and Total Hip Prosthesis" is divided into the following sections.
--- Part 1. Classification and dimensioning;
--- Part 2. Metal, ceramic and plastic joint surfaces;
--- Part 3. (reserved);
--- Part 4. Fatigue performance test and performance requirements for shank femoral components;
--- Part 5. (reserved);
--- Part 6. neck fatigue performance test and performance requirements for shank femoral components;
--- Part 7. (reserved);
--- Part 8. Fatigue performance of shank femoral components with torque;
--- Part 9. (reserved);
--- Part 10. Determination of the antistatic force of the combined femoral head.
This part is the fourth part of YY/T 0809.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY/T 0809.4-2010. Compared with YY/T 0809.4-2010, major technical changes except editorial changes
as follows.
---The standard name was modified from "Determination of fatigue performance of shank femoral components" to "Fatigue performance test and performance of shank femoral components"
Seeking", the standard has increased the fatigue performance requirements;
--- Adjusted the test parameters.
This section uses the translation method equivalent to ISO 7206-4.2010 "Surgical Implant Part and Total Hip Prosthesis Part 4. Belt
Fatigue performance test and performance requirements for shank femoral components.
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
---GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD);
---GB/T 25917-2010 axial force fatigue testing machine dynamic force calibration (ISO 4965. 1979, MOD);
---YY/T 0809.1-2010 Surgical implant part and total hip prosthesis Part 1. Classification and dimensioning
(ISO 7206-1.2008, IDT).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, orthopedic implants subcommittee (SAC/TC110/
SC1).
This section drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai University, Chuangsheng Medical Devices (China) Co., Ltd., strong
Health (Suzhou) Medical Equipment Co., Ltd.
The main drafters of this section. Dong Shuangpeng, Zhang Zhenghui, Wang Wei, Hua Zikai, Chen Changsheng, Wang Jian, Zhao Yuanyi, Chen Ruiqi.
The previous versions of the standards replaced by this standard are.
---YY/T 0809.4-2010.
Introduction
Some aspects of the previous version are not fully described, and some aspects of the test method do not reflect actual test practices, as follows
Said.
a) The test conditions of the anteversion femoral stem result in a significant reduction in the bending force in the sagittal plane. Compared to the "worst case" of the non-forwardly inclined femoral stem
Condition, this test condition becomes the "best case" because it does not consider the rotation of such a femoral stem when implanted in the human body, so it cannot be reversed.
Reflects high stress conditions in the human body.
b) The test of the femoral stem with a CT value less than 120 mm was not considered.
Note. The CT value is the distance from the center of the femoral head to the most distal point of the femoral stem.
c) The level of embedding has changed compared to YY/T 0809.4-2010, but is specified in the corresponding YY/T 0809.8-2010
The performance requirements have not changed.
To compensate for these deficiencies, test conditions were defined for three types of femoral stems with different length ranges; more precise description of the test procedure and
The definition of the stem axis, especially the forward-tilt stem; and the specified test conditions and performance requirements in YY/T 0809.8-2010
Adapted.
This standard makes laboratory operations more precise and simple, and clearly divides the femoral stem into three types.
---CT ≤ 120mm femoral stem;
---CT > 250mm femoral stem.
This standard covers the performance requirements of these components, which improves the acceptability of test methods and the reproducibility of test results.
Surgical implant part and total hip prosthesis
Part 4. Fatigue properties of femoral components with shank
Test and performance requirements
1 Scope
This section of YY/T 0809 specifies the fatigue of shank femoral components in partial and total hip arthroplasty under specific test conditions.
Test method for performance. This section also specifies test conditions to consider important parameters affecting the test components and describes the installation of the test specimens.
method.
This section also specifies test parameters and femoral component fatigue limit requirements, including fatigue limit values and the corresponding number of load cycles.
This section applies to prostheses with a symmetrical plane or prefabricated forward or double-sided shank.
This part does not include the inspection method of the sample after the completion of the fatigue test. The content of this part is determined by the laboratory and the sample provider.
For the fatigue test of the combined femoral component, a liquid test environment for the femoral component is specified.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
ISO 3696 Laboratory Analytical Water Specification and Test Method (Waterforanalyticallaboratoryuse-Specification)
Andtestmethods)
ISO 4965 axial load fatigue tester dynamic force calibration strain measurement technology (Axialloadfatiguetestingma-
chines-Dynamicforcecalibration-Straingaugetechnique)
ISO 7206-1 Surgical Implant Part and Total Hip Prosthesis Part 1. Classification and Dimensioning (Implantsforsur-
gery-Partialandtotalhipjointprostheses-Part 1. Classification and designationofdimensions)
3 Terms and definitions
The following terms and definitions as defined by ISO 7206-1 apply to this document.
3.1
Neck combination handle modularneckstem
A handle that is used by taper fitting with a proximal end of the femoral neck with a self-locking taper.
3.2
Fatigue limit endurancelimit
FD
After ND cycle tests, the sample does not have maximum force for damage and deformation.
3.3
Fatigue cycle number endurancecycles
ND
The number of specified cycles under the test force value.
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