BS ISO 16428:2005 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.
ISO 16428:2005