YY/T 0651.1-2016Implants for surgery—Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test (English PDF)

Foreword

YY/T 0651 "Surgical implants for total hip prosthesis wear" is divided into the following three parts.

- Part 1. Load and displacement parameters for wear testing machines and associated test environmental conditions;

- Part 2. Methods of measurement;

Part 3. Load and displacement parameters for track bearing wear testing machines and associated test environmental conditions. This part is part 1 of YY/T 0651.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This part uses the translation method equivalent to ISO 14242-1.:2012 "Surgical implants for total hip prosthesis wear Part 1. hip Joint load test machine load and displacement parameters and related test environmental conditions ". Appendix A lists the parameters for obtaining the rotation and load curves Formula.

This part replaces YY/T 0651.1-2008 "Surgical implants for total hip prosthesis wear Part 1. Hip wear test Machine load and displacement parameters and related test environmental conditions ", compared with YY/T 0651.1-2008, in addition to editorial modification of the main technology The changes are as follows.

--- YY/T 0651.1-2008 only includes internal rotation/external rotation movement, this standard includes three kinds of movement, namely the internal rotation/external rotation movement, adduction / Outreach and flexion/stretching;

--- YY/T 0651.1-2008 in the test medium in the protein concentration of not less than 17g/L, the standard provisions of the test medium Of the protein concentration of 30g/L ± 2g/L;

--- YY/T 0651.1-2008 does not include the contents of the temperature control system, without considering the impact of temperature on the wear and tear, this standard Including the contents of the temperature control system;

--- YY/T 0651.1-2008 does not include the contents of the loading and motion curves. This standard includes the loading and motion curves of the test.

In this part of the normative reference to the international documents have a consistent correspondence between the following documents.

Analysis of laboratory water specifications and test methods (ISO 3696. 1987, MOD); GB/T 6682-2008;

Surgical implants and full hip prostheses - Part 1. Classification and dimensioning - YY/T 0809.1-2010 (ISO 7206-1.:2008, IDT);

- YY/T 0651.2-2008 Surgical implants for wearing all hip prostheses Part 2. Methods of measurement (ISO 14242- 2..2000, IDT).

1 Scope

This part of YY/T 0651 specifies the relative angular motion of the joint parts during the total hip prosthesis wear test, the test loading mode, Test speed and duration, sample assembly, and test environment requirements.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

ISO 3696 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specification andtestmethods)

ISO 7206-1 Surgical Implants Part and Total Hip Joints Part 1. Classification and Dimensioning (Implantsforsur- gery-Partialandtotalhip-jointprostheses-Part 1. Classificationanddesignationofdimensions)

ISO 14242-2 Peripheral prosthesis implantation of surgical implants - Part 2. Methods of measurement (Implantsforsurgery- Wearoftotalhip-jointprostheses-Part 2. Methodsofmeasurement)

3 Terms and definitions ISO 7206-1 and the following

terms and definitions apply to this document.

4 Principle

The femoral component and acetabular component of the test sample were assembled in the intended combination. Through the test device to make between the two at any time