YY/T 0809.6-2018Implants for surgery—Partial and total hip joint prostheses - Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components (English PDF)

Foreword

YY/T 0809 "Surgical Implant Part 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. Fatigue performance test and performance requirements for shank femoral components;

--- Part 6. neck fatigue performance test and performance requirements for shank femoral components;

--- Part 8. Fatigue performance of shank femoral components with torque;

--- Part 10. Determination of the antistatic force of the combined femoral head. This part is part 6 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 0809.6-2010 "Surgical Implant Part and Total Hip Prosthesis Part 6. Head with Mandible Femur And determination of neck fatigue performance. Compared with YY/T 0809.6-2010, the main technical changes except editorial changes are as follows.

---The standard name was modified from "Determination of fatigue performance of head and neck with shank femoral components" to "Neck fatigue performance of shank femoral components" Test and performance requirements", the standard has increased fatigue performance requirements;

--- Adjusted the test parameters.

This section uses the translation method equivalent to ISO 7206-6:2013 "Surgical Implant Part and Total Hip Prosthesis Part 6. Belt Neck 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).

1 Scope

This section of YY/T 0809 specifies neck fatigue of the femoral component with partial and total hip arthroplasty under specific test conditions.

Test methods and performance requirements for performance. This section does not include studies on the performance of the femoral head or head and neck.

This section applies to both combined and non-combined designs made of metal or non-metallic materials.

This section also specifies the conditions of the test, considers the important parameters that affect the test femur components, and describes the method of installation of the specimen.

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 3696:1987 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specifica- Tionandtestmethods)

ISO 4965 Metallic material uniaxial fatigue test dynamic force calibration (Metalicmaterials-Dynamicforcecalibration Foruniaxialfatiguetesting)

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.

4 Principle

The sample is embedded in the medium. For the combined femoral stem, the unembedded portion of the sample is submerged in the liquid medium. Applying to the head of the sample Add cyclic load until any of the conditions described in 8.10 occur.

5 Materials

5.1 Embedding medium. A casting medium, which should.