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iso-16163-corrosion-of-metals-in-medical-implants
Corrosion and Salt Spray Testing ASTM B117 Salt Spray (Fog) Testing for Corrosion ResistanceASTM B117 Salt Spray TestingASTM B368 Corrosion of Stainless SteelsASTM B537 Galvanic Corrosion TestingASTM B845 Cyclic Corrosion TestingASTM D5894 Cyclic Exposure of Painted PanelsASTM D610 Evaluation of Rust on Painted SurfacesASTM D714 Blistering Resistance of PaintsASTM D870 Water Resistance Testing of CoatingsASTM F2129 Corrosion Testing of Cardiovascular DevicesASTM F2129 Cyclic Potentiodynamic Polarization for StentsASTM F746 Crevice Corrosion EvaluationASTM F746 Crevice Corrosion TestingASTM G123 Cyclic Corrosion TestASTM G123 Cyclic Corrosion TestingASTM G142 Evaluation of Corrosion in Condensed EnvironmentsASTM G15 Electrochemical Testing MethodsASTM G150 Cyclic Corrosion Tests Using Alternate ExposuresASTM G18 Accelerated Corrosion TestingASTM G18 Accelerated Corrosion Testing of MetalsASTM G182 Cyclic Corrosion Testing for CoatingsASTM G2 Salt Fog Testing for Coated SurfacesASTM G28 Methods for Accelerated Corrosion TestingASTM G31 Immersion Corrosion Test MethodASTM G31 Immersion Corrosion TestsASTM G31 Laboratory Immersion Corrosion TestingASTM G31 Laboratory Immersion TestASTM G31-12 Corrosion Immersion Test for MetalsASTM G44 Corrosion Fatigue TestASTM G44 Corrosion Fatigue TestingASTM G46 Evaluation of Corrosion Under InsulationASTM G48 Pitting and Crevice Corrosion TestingASTM G48A Pitting and Crevice Corrosion Resistance TestASTM G49 Pitting Corrosion ResistanceASTM G5 Potentiostatic and Potentiodynamic Anodic PolarizationASTM G50 Evaluation of Corrosion in Aqueous MediaASTM G61 Corrosion Fatigue of MetalsASTM G61 Corrosion Fatigue of MetalsASTM G85 Annex A1 – Acetic Acid Salt SprayASTM G85 Annex A2 – Acidified Salt Fog TestASTM G85 Annex A3 – Prohesion TestASTM G85 Annex A4 – Acetic Acid Salt Spray TestASTM G85 Annex A5 – SO2 Salt Fog TestASTM G85 Cyclic Corrosion TestASTM G85 Modified Salt Spray Testing ProceduresASTM G95 Cyclic Corrosion Test ProceduresASTM G96 Corrosion Testing of Metals in BiofluidsISO 10289 Corrosion Testing in Simulated Body FluidsISO 10289 Corrosion Testing in Synthetic Body FluidsISO 10289 Electrochemical Tests for Medical DevicesISO 10993-18 Chemical Characterization Considering CorrosionISO 11130 Microbial Corrosion TestingISO 11130 Microbiologically Influenced Corrosion TestingISO 11474 Electrochemical Testing of Corrosion InhibitorsISO 11845 Corrosion of Metallic Materials in Blood ContactISO 11845 Corrosion Resistance of Materials in Medical ApplicationsISO 11955-2 Determination of Corrosion ResistanceISO 12944 Corrosion Protection of Steel Structures by PaintsISO 12944 Protective Coatings for Steel StructuresISO 14971 Risk Management Including Corrosion EffectsISO 16701 Corrosion Testing of Medical DevicesISO 16701-1 Corrosion Testing for Implant DevicesISO 16772 Corrosion Protection SystemsISO 16772 Protective Coatings and Corrosion PreventionISO 16773-1 Corrosion Protection by Organic CoatingsISO 17474 Corrosion Tests on MetalsISO 17475 Electrochemical Techniques in Corrosion TestingISO 19277 Guidelines for Corrosion Testing in Medical DevicesISO 20340 Performance Requirements for Protective CoatingsISO 20340 Specification for Paint PerformanceISO 2360 Measurement of Metal ThicknessISO 2360 Measurement of Metal Thickness by Eddy CurrentISO 2812 Paint Resistance to HumidityISO 2812 Paints and Varnishes – Determination of Resistance to HumidityISO 3651-2 Evaluation of Metallic Corrosion Using Salt SprayISO 4628 Visual Evaluation of CorrosionISO 4628 Visual Examination of Paints and CorrosionISO 4628-1 Visual Rating of Corrosion and Coating DefectsISO 6270-1 Resistance to HumidityISO 8044 Corrosion Testing MethodsISO 8044 General Principles of CorrosionISO 8044 General Principles of Corrosion TestingISO 8407 Cleaning of Corroded SurfacesISO 8407 Corrosion Removal from Corroded SurfacesISO 8407 Removal of Corrosion Products from Test SpecimensISO 9223 Corrosivity of AtmospheresISO 9224 Corrosion Rate MeasurementISO 9226 Corrosion Product AnalysisISO 9226 Corrosion Product Analysis TechniquesISO 9227 Corrosion Tests in Artificial Atmospheres - Salt Spray TestISO 9227 Salt Spray Testing

Comprehensive Guide to ISO 16163 Corrosion of Metals in Medical Implants Laboratory Testing Service Provided by Eurolab

ISO 16163 is an international standard that specifies the requirements for the laboratory testing of corrosion of metals in medical implants. This standard is developed and published by the International Organization for Standardization (ISO), which brings together experts from around the world to establish common standards for a wide range of industries.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 16163 Corrosion of Metals in Medical Implants testing is governed by various national and international regulations. In the European Union, for example, medical devices must comply with Directive 2007/47/EC, which requires manufacturers to conduct biocompatibility testing, including corrosion testing, on their products. Similarly, in the United States, the FDA regulates medical devices under Title 21 of the Code of Federal Regulations (CFR), which includes requirements for biocompatibility testing.

International and National Standards

The following international and national standards apply to ISO 16163 Corrosion of Metals in Medical Implants testing:

  • ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood

  • ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

  • EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from corrosion or extraction

  • TSE (Turkish Standards Institution) EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from corrosion or extraction

    • Standard Development Organizations

    The standard development organizations involved in the creation and maintenance of ISO 16163 include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution and Updates of Standards

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, or new scientific knowledge. The standard development process typically involves the following steps:

    1. Identification of a need for a new standard or update

    2. Formation of a technical committee to develop the standard

    3. Publication of the draft standard for public comment

    4. Finalization and publication of the standard

    Standard Numbers and Scope

    The following standard numbers and their scope are relevant to ISO 16163 Corrosion of Metals in Medical Implants testing:

  • ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from corrosion or extraction

    • This standard specifies the requirements for identifying and quantifying degradation products from corrosion or extraction.

  • EN ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood

    • This standard specifies the requirements for selecting tests for interaction with blood.

    Standard Compliance Requirements

    The following industries require compliance with ISO 16163 Corrosion of Metals in Medical Implants testing:

  • Medical device manufacturers

  • Orthopedic implant manufacturers

  • Cardiovascular device manufacturers

    • Compliance with this standard is necessary to ensure the safety and efficacy of medical implants, which are subject to rigorous regulatory requirements.

    In addition to ISO 16163 Corrosion of Metals in Medical Implants testing, other relevant standards include:

  • ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood

  • ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

    • These standards provide a framework for evaluating the biocompatibility of medical devices, including corrosion testing.

    Why this Specific Test is Needed and Required

    ISO 16163 Corrosion of Metals in Medical Implants testing is necessary to ensure the safety and efficacy of medical implants. Corrosion can lead to the release of toxic substances, which can cause adverse reactions in patients.

    Business and Technical Reasons for Conducting Testing

    The business and technical reasons for conducting ISO 16163 Corrosion of Metals in Medical Implants testing include:

  • Compliance with regulatory requirements

  • Ensuring product safety and efficacy

  • Reducing liability risks

    • Consequences of Not Performing this Test

    Failure to perform ISO 16163 Corrosion of Metals in Medical Implants testing can result in the following consequences:

  • Non-compliance with regulatory requirements

  • Product recalls or withdrawals

  • Financial losses due to liability claims

    • Industries and Sectors that Require Testing

    The industries and sectors that require ISO 16163 Corrosion of Metals in Medical Implants testing include:

  • Medical device manufacturers

  • Orthopedic implant manufacturers

  • Cardiovascular device manufacturers

    • These industries must ensure the biocompatibility of their products, including corrosion testing.

    In addition to ISO 16163 Corrosion of Metals in Medical Implants testing, other relevant standards include:

  • ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood

  • ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

    • These standards provide a framework for evaluating the biocompatibility of medical devices, including corrosion testing.

    ...

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