YY/T 0809.8-2010 English PDF (YY/T0809.8-2010)

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YY/T 0809.8-2010: Implants for surgery. Partial and total hip joint prostheses. Part 8: Endurance performance of stemmed femoral components with application of torsion
YY/T 0809.8-2010
Implants for surgery.Partial and total hip joint prostheses.Part 8. Endurance performance of stemmed femoral components with application of torsion
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Implants and total hip prostheses
Part 8. There TORQUE
Fatigue properties of stemmed femoral components
Part 8. Enduranceperformanceofstemmedfemoral
(ISO 7206-8.1995, MOD)
Issued on. 2012-06-01 2010-12-27 implementation
State Food and Drug Administration issued
Foreword
YY/T 0809 "Implants and total hip prosthesis" is expected to be divided into the following sections.
--- Part 1. Classification and dimensioning;
--- Part 2. metal, ceramic and plastic joint surfaces;
--- Part 4. Determination of fatigue properties of stemmed femoral component;
--- Part 6. Determination of stemmed femoral component head and neck fatigue properties;
--- Part 8. a torque acts of stemmed femoral component fatigue performance;
--- Part 10. Combined femoral anti-static load force measurement.
This section YY/T 0809 Part 8.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses redrafted law revision adopted 7206-8 ISO .1995 department "surgical implants Partial and total hip prosthesis Article 8
Points. a torque acting stemmed femoral component fatigue performance. "
This part of ISO 7206-8.1995 as compared to only normative references have been adjusted to technical differences, in order to adapt to China
Technical conditions, adjust the focus reflected in Chapter 2, "Normative references", the specific adjustments are as follows.
--- With YY/T 0809.4-2010 instead of ISO 7206-4. 1989.
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.
The main drafters of this section. Dongshuang Peng, Zhang Lu, Jiaoyong Zhe.
Implants and total hip prostheses
Part 8. There TORQUE
Fatigue properties of stemmed femoral components
1 Scope
YY/T 0809 provisions of this part of the test under certain conditions, the torque acting portion and a total hip prosthesis stemmed femoral portion
Fatigue performance pieces.
This section does not apply to the following.
a) special clinical use of the prosthesis;
Midline b) handle three-dimensional curves, not in the same plane with the axis of the neck.
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.
YY/T 0809.4-2010 Implants and total hip joint prostheses - Part 4. Fatigue properties of stemmed femoral components
Determination (ISO 7206-4.2002, MOD)
Test Conditions
The femoral component should be tested in a finished state.
4 fatigue properties
According to the provisions of YY/T 0809.4 when tested in 2kN cyclic loading (minimum load of 300N, the maximum load of 2.3kN)
Through the action of 5 × 106 cycles, the femoral component should not be broken. Loading mechanism (see YY/T 0809.4-2010,7.9) can not be completed before the end
Stop testing, unless the sample occurs in the embedded media loose.