Draft
International Standard
ISO/DIS 16428
Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
Reference number
ISO/DIS 16428
Edition 2
© ISO 2026
Draft International Standard
Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 16428:2005

Abstract

ISO 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The testing 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 ISO 16428:2005. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of ISO 16428:2005.

General information

  • Status
     : Under development
    Stage
    : DIS registered [40.00]
  • Edition
     : 2
    Number of pages
     : 8
  • Technical Committee :
    ISO/TC 150/SC 1
    ICS :
    11.040.40 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

Got a question?

Check out our Help and Support

  2. Store
  3. Store
  4. ICS
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO/DIS 16428