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  • 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

    Available format(s):  PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  13-07-2004

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 150/SC 1
    Development Note Supersedes ISO/DIS 16429 (07/2004)
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO JIS T 0302
    Publisher International Organization for Standardization
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    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)

    Standards Referencing This Book - (Show below) - (Hide below)

    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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