YY/T0809.4-2018 Partial and total hip joint prostheses Fatigue Test
→YY/T0809.4-2018 surgical implants and total hip prostheses - part 4: fatigue performance tests and performance requirements for shank femoral components.
→It will take effect from October 1, 2019.YY/T0809.4-2018 replaces YY/T0809.4-2010Announcement of 15 standards for the medical device industry of the state drug administration (no.72 of 2018).
→YY/T0809.4-2018 stipulates the test method for determining the fatigue performance of femoral components with shank in partial and total hip replacement under specific test conditions.
→YY/T0809.4-2018 stipulates the test conditions to consider the important parameters affecting the test parts, and describes the installation method of the sample.
→YY/T0809.4-2018 is suitable for the prosthesis with symmetrical plane or precast anteversion or double-curved shank.
→YY/T0809.4-2018 does not include the test method of the sample after the completion of the fatigue test, and the content of this part shall be determined by the laboratory and the sample provider through consultation.For the fatigue test of the combined femoral component, the liquid test environment for the femoral component is specified.
→Fatigue performance test of 10kN shank femoral component, Fatigue test of 5kN planar femoral prosthesis, Fatigue test of 5kN prefabricated pretilting femoral prosthesis, Fatigue test of femoral prosthesis with double curved shank, Fatigue test of femoral component head, Neck fatigue test of femoral component, Determination of static load resistance of combined femoral head, Femoral neck static load test, Static force test for failure of metal femoral head, Non-metallic femoral head prosthesis for physical strength measurement, Static force test of fracture of femoral head, Vertebral body spinal implant test, Fatigue test of tibial bracket, Constant amplitude stress-strain fatigue test, Fatigue test of 5kN bone material, Axial load fatigue test for 5kN bone components, Dynamic fatigue test for 1kN/3kN/10kN bone components, ISO 7206-4;5kN surgical implant fatigue test system, 10kN medical device fatigue life test, 10kN bone plate bending fatigue testing machine, HRJ medical testing machine, Mechanical test of 50kN ~ 300kN bone plate, Torque test for bone screws,10kN bone graft fatigue test, 3kN bone nail fatigue testing machine, 5kN bone needle fatigue testing machine, 10kN bone bar fatigue testing machine, 10kN patellar concentrator fatigue testing machine