Foreword

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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacements.

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Introduction

Evaluation of the wear of shoulder-joint replacement prostheses plays an important role in the development of bearing materials and designs and in the continual assessment of current products.

This document is applied for the quantitative and qualitative assessment of the wear of anatomic total shoulder-joint prostheses.

A reliable testing method is provided that allows for testing on commonly used knee wear simulators (see ISO 14243-1:2009, 4.3). Other types of simulators can be used provided they meet the requirements described in this document.

1 Scope

This document describes a wear testing method of anatomic total shoulder-joint prostheses that specifies relative motion between the implant components and the pattern of the applied forces. This document includes the basic configuration of the simulator, sample number and alignment, test environment, speed and duration of testing, verification of inputs, measurement of kinematics and other details of the procedure and reporting.

The primary outcome is the evaluation of wear performance of total anatomic shoulder-joint prostheses, which includes both qualitative and quantitative methods. The qualitative methods of wear evaluation are included in this document and the methods of quantitative wear measurement are covered in ISO 14243-2 .

2 Normative references

3 Terms and definitions

4 Principle

4.1 Reference position

4.2 Physiological motion simulated

4.3 Component alignment in the knee simulator

5 Test specimens, soak control specimen, sample size and lubricant

5.1 Test specimens

5.2 Soak control specimen

5.3 Sample size

5.4 Lubricant (fluid test medium)

6 Apparatus

6.1

6.2

6.3

6.4

6.5

6.6

6.7

6.8

6.9

6.10

6.11

6.12

7 Procedure

7.1

7.2

7.3

7.4

7.5

7.6

7.7

7.8

7.9

7.10

7.11

7.12

7.13

7.14

7.15

8 Test report

9 Disposal of test specimens

Bibliography