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

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.

Implants chirurgicaux — Mesurages sur de longues périodes du potentiel en circuit ouvert pour l'évaluation du comportement à la corrosion des matériaux métalliques et dispositifs médicaux implantables

General Information

Status
Published
Publication Date
12-Jul-2004
Technical Committee
Drafting Committee
Current Stage
9020 - International Standard under periodical review
Start Date
15-Jan-2024
Completion Date
15-Jan-2024
Ref Project

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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
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 16429
First edition
2004-07-01
Implants for surgery — Measurements of
open-circuit potential to assess corrosion
behaviour of metallic implantable
materials and medical devices over
extended time periods
Implants chirurgicaux — Mesurages sur de longues périodes du
potentiel en circuit ouvert pour l'évaluation du comportement à la
corrosion des matériaux métalliques et dispositifs médicaux
implantables

Reference number
ISO 16429:2004(E)
©
ISO 2004

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ISO 16429:2004(E)
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ISO 16429:2004(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Significance and application . 2
4.1 Principle . 2
4.2 Significance of the measurements . 4
4.3 Application . 4
5 Apparatus . 5
6 Specimen preparation . 5
6.1 Type of specimen . 5
6.2 Surface preparation . 6
6.3 Specimen mounting . 6
7 Environmental conditions . 6
7.1 General . 6
7.2 Testing solution . 6
7.3 Testing temperature . 6
7.4 pH value . 7
7.5 Aeration . 7
7.6 Volume of testing solution .
...

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