BS ISO 16428:2005

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Significance and application
  4.1 Significance of test solution
  4.2 Application
5 Environmental testing conditions
  5.1 Test solution
  5.2 Testing temperature
  5.3 pH value
  5.4 Aeration
  5.5 Volume of test solution
  5.6 Circulation of the solution
  5.7 Test chamber
6 Test specimens
7 Evaluation and reporting
  7.1 Evaluation of test results
  7.2 Test report
Annex A (informative) Additional test solutions
Annex B (informative) Considerations for surface
                      preparation and test evaluation
Bibliography

Provides standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices.

This International Standard specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The test conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution.

These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests.

Typical articulating joint simulator tests and aspects particular to the dental field are not considered by this International Standard. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of this International Standard.