ISO 16429:2004 PDF

Scope: This International Standard specifies a test method for measurements over extended time periods of the open-circuit potential of implant materials and surgically implantable devices immersed in a test environment related to body fluid, using a standard corrosion test cell to study the electrochemical corrosion properties of the devices. This method of monitoring the open-circuit potential can also be combined with mechanical static or dynamic loading tests. This International Standard is applicable in particular to metallic materials which form passive layers with protective properties against corrosion, as typical for surgical implant materials. This test method is intended for the investigation of single metallic materials or alloys. It is not applicable to dissimilar material combinations, which require particular considerations in measuring and interpreting the results.

ISO 16429:2004 Referenced Document

ISO 16428 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices*， 2005-04-01 Update
ISO 3696 Water for analytical laboratory use; Specification and test methods

2004 ISO 16429:2004 Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods