Standard Number: YY/T 0809.4-2018(YY/T0809.4-2018)
Chinese:外科植入物 部分和全髋关节假体 第4部分：带柄股骨部件疲劳性能试验和性能要求
English:Implants for surgery – Partial and total hip joint prostheses – Part 4:Determination of endurance properties and performance of stemmed femoral components
Effective Date:2019-10-01
ICS:11.040.40
Standard Applicability:This standard specifies test methods for determining the fatigue performance of stemmed femoral components in partial and total hip replacements under specified test conditions. This standard also specifies test conditions to take into account important parameters affecting the test components and describes specimen mounting methods. In addition, this standard specifies the test parameters and fatigue limit requirements for the femoral component, specifying the fatigue limit values and the corresponding number of load cycles. This standard applies to prostheses with symmetrically planar or prefabricated anteriorly inclined or shanks bent on both sides. This standard does not include methods for examining specimens after completion of the fatigue test; this section is to be determined by the laboratory in consultation with the specimen provider. For the fatigue test of combined femoral components, the liquid test environment of femoral components is specified. This standard replaces YY/T 0809.4-2010 “Surgical implants Partial and total hip prosthesis Part 4: Determination of fatigue properties of femoral components with stem”.
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