ISO 16429:2004
(Main)Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
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
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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
---------------------- Page: 1 ----------------------
ISO 16429:2004(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
©
ii ISO 2004 – All rights reserved
---------------------- Page: 2 ----------------------
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 .
...
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
---------------------- Page: 1 ----------------------
ISO 16429:2004(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
©
ii ISO 2004 – All rights reserved
---------------------- Page: 2 ----------------------
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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