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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

Publication date:   Jul 13, 2004

General information

90.93 Standard confirmed   Jun 12, 2024

ISO

ISO/TC 150/SC 1 Materials

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

ISO 16429:2004 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.
ISO 16429:2004 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.

Life cycle

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PUBLISHED
ISO 16429:2004
90.93 Standard confirmed
Jun 12, 2024