ISO 16429:2004
Current
The latest, up-to-date edition.
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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13-07-2004
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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.
| Committee |
ISO/TC 150/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 16429 (07/2004)
|
| DocumentType |
Standard
|
| Pages |
10
|
| ProductNote |
THIS STANDARD ALSO REFERS TO JIS T 0302
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NEN ISO 16429 : 2004 | Identical |
| DIN EN ISO 12417-1:2016-02 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| 04/300654 DC : DRAFT JAN 2004 | BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
| ISO 13179-1:2014 | Implants for surgery Plasma-sprayed unalloyed titanium coatings on metallic surgical implants Part 1: General requirements |
| BS EN ISO 14630:2012 | Non-active surgical implants. General requirements |
| 14/30251609 DC : 0 | BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| BS ISO 13179-1:2014 | Implants for surgery. Plasma-sprayed unalloyed titanium coatings on metallic surgical implants General requirements |
| 12/30212355 DC : 0 | BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA SPRAYED COATINGS OF UNALLOYED TITANIUM - PART 1: GENERAL REQUIREMENTS |
| UNE 112086:2016 | Tribocorrosion testing procedure for passivating materials. |
| I.S. EN ISO 14630:2012 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| DD ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| BS EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements |
| ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| UNI EN ISO 14630 : 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| 13/30283636 DC : 0 | BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 12417-1:2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
| UNE-EN ISO 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| ISO/TR 12417-2:2017 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
| AAMI ISO 12417-1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| UNE-EN ISO 14630:2013 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| AAMI ISO TIR 12417 : 2011 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ISO 3585:1998 | Borosilicate glass 3.3 — Properties |
| ISO 11845:1995 | Corrosion of metals and alloys General principles for corrosion testing |
| ISO 8044:2015 | Corrosion of metals and alloys Basic terms and definitions |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 16428:2005 | Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices |
| ASTM G 3 : 2014 | Standard Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing |
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