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  • ISO 16428:2005

    Current The latest, up-to-date edition.

    Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

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

    Language(s):  English, Russian

    Published date:  12-04-2005

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The testing conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution.

    These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests.

    Typical articulating joint simulator tests and aspects particular to the dental field are not considered by ISO 16428:2005. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of ISO 16428:2005.

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

    Committee ISO/TC 150/SC 1
    Development Note Supersedes ISO/DIS 16428 (04/2005)
    Document Type Standard
    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)
    16/30332223 DC : 0 BS ISO 6474-1 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 1: CERAMIC MATERIALS BASED ON HIGH PURITY ALUMINA
    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)
    ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
    BS ISO 6474-2:2012 Implants for surgery. Ceramic materials Composite materials based on a high-purity alumina matrix with zirconia reinforcement
    14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    ISO 6474-2:2012 Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
    17/30361518 DC : 0 BS ISO 6474-2 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 2: COMPOSITE MATERIALS BASED ON A HIGH-PURITY ALUMINA MATRIX WITH ZIRCONIA REINFORCEMENT
    ISO 16402:2008 Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics
    BS ISO 16402:2008 Implants for surgery. Acrylic resin cement. Flexural fatigue testing of acrylic resin cements used in orthopaedics
    UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
    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
    DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
    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
    03/305240 DC : 0 BS ISO 16429 - IMPLANTS FOR SURGERY - LONG-TERM MEASUREMENTS OF OPEN-CIRCUIT POTENTIAL TO ASSESS CORROSION BEHAVIOUR OF METALLIC IMPLANTABLE MATERIALS AND MEDICAL DEVICES
    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)

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

    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
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