YY/T 0809.4-2018Implants for surgery—Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components (English PDF)

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).

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.

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 document. 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.