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iso-10993-18-chemical-characterization-considering-corrosion
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 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 16163 Corrosion of Metals in Medical ImplantsISO 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 10993-18 Chemical Characterization Considering Corrosion Laboratory Testing Service by Eurolab

ISO 10993-18 is a standard that governs the chemical characterization considering corrosion testing of medical devices. This standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices.

The ISO 10993 series is developed by the International Organization for Standardization (ISO) in collaboration with the International Electrotechnical Commission (IEC). The standards are designed to ensure that medical devices meet specific safety and performance requirements.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-18 chemical characterization considering corrosion testing is governed by various international and national standards. These standards include:

  • ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)

  • ISO 10993-17:2019 (Biological evaluation of medical devices - Part 17: Tests for cytotoxicity in vitro)

  • ISO 10993-18:2020 (Biological evaluation of medical devices - Part 18: Chemical characterization considering corrosion)

  • EU Medical Device Regulation (MDR) 2017/745

  • US FDA Guidance on Cytotoxicity Testing

    • International and National Standards

    The following standards are applicable to ISO 10993-18 chemical characterization considering corrosion testing:

  • ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)

  • ISO 10993-17:2019 (Biological evaluation of medical devices - Part 17: Tests for cytotoxicity in vitro)

  • ISO 10993-18:2020 (Biological evaluation of medical devices - Part 18: Chemical characterization considering corrosion)

  • EN ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)

  • ASTM F748-12 (Standard Practice for Selecting, Testing, and Specifying Biomedical Materials)

    • Standard Development Organizations

    The standard development organizations involved in the development of ISO 10993-18 are:

  • International Organization for Standardization (ISO)

  • International Electrotechnical Commission (IEC)

  • European Committee for Standardization (CEN)

  • American Society for Testing and Materials (ASTM)

    • Evolution of Standards

    Standards evolve and get updated to reflect changes in technology, scientific knowledge, and regulatory requirements. The ISO 10993 series is regularly reviewed and updated to ensure that it remains relevant and effective.

    Standard Numbers and Scope

    The standard numbers and scope are as follows:

  • ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    • Scope: Provides guidelines for the biological evaluation of medical devices.

  • ISO 10993-17:2019 - Biological evaluation of medical devices - Part 17: Tests for cytotoxicity in vitro

    • Scope: Specifies tests for cytotoxicity in vitro.

  • ISO 10993-18:2020 - Biological evaluation of medical devices - Part 18: Chemical characterization considering corrosion

    • Scope: Provides guidelines for the chemical characterization considering corrosion testing of medical devices.

    Standard Compliance Requirements

    Compliance with ISO 10993-18 is required for medical devices that are subject to biological evaluation. The standard applies to all types of medical devices, including implants, surgical instruments, and diagnostic equipment.

    Why this specific test is needed and required

    ISO 10993-18 chemical characterization considering corrosion testing is necessary to evaluate the potential toxicity and corrosion of medical devices. This testing helps ensure that medical devices are safe for use in humans and do not cause harm or injury.

    Business and Technical Reasons

    The business and technical reasons for conducting ISO 10993-18 chemical characterization considering corrosion testing include:

  • To comply with regulatory requirements

  • To ensure product safety and performance

  • To reduce the risk of adverse events

  • To improve customer confidence and trust

    • Consequences of not performing this test

    Failure to perform ISO 10993-18 chemical characterization considering corrosion testing can result in:

  • Non-compliance with regulatory requirements

  • Product recalls or withdrawals

  • Loss of customer confidence and trust

  • Damage to business reputation

    • Industries and Sectors that Require this Testing

    The following industries and sectors require ISO 10993-18 chemical characterization considering corrosion testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Research institutions

    • Risk Factors and Safety Implications

    The risk factors and safety implications associated with medical devices include:

  • Toxicity and cytotoxicity

  • Corrosion and biodegradation

  • Infection and inflammation

  • Tissue damage and necrosis

    • ISO 10993-18 chemical characterization considering corrosion testing helps to mitigate these risks by evaluating the potential toxicity and corrosion of medical devices.

    The business and technical reasons for conducting ISO 10993-18 chemical characterization considering corrosion testing include:

  • To ensure product safety and performance

  • To reduce the risk of adverse events

  • To improve customer confidence and trust

  • To comply with regulatory requirements

    • Failure to perform ISO 10993-18 chemical characterization considering corrosion testing can result in:

  • Non-compliance with regulatory requirements

  • Product recalls or withdrawals

  • Loss of customer confidence and trust

  • Damage to business reputation

    • The following industries and sectors require ISO 10993-18 chemical characterization considering corrosion testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Research institutions

    • The risk factors and safety implications associated with medical devices include:

  • Toxicity and cytotoxicity

  • Corrosion and biodegradation

  • Infection and inflammation

  • Tissue damage and necrosis

    • ISO 10993-18 chemical characterization considering corrosion testing helps to mitigate these risks by evaluating the potential toxicity and corrosion of medical devices.

    The business and technical reasons for conducting ISO 10993-18 chemical characterization considering corrosion testing include:

  • To ensure product safety and performance

  • To reduce the risk of adverse events

  • To improve customer confidence and trust

  • To comply with regulatory requirements

    • Failure to perform ISO 10993-18 chemical characterization considering corrosion testing can result in:

  • Non-compliance with regulatory requirements

  • Product recalls or withdrawals

  • Loss of customer confidence and trust

  • Damage to business reputation

    • The following industries and sectors require ISO 10993-18 chemical characterization considering corrosion testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Research institutions

    • The risk factors and safety implications associated with medical devices include:

  • Toxicity and cytotoxicity

  • Corrosion and biodegradation

  • Infection and inflammation

  • Tissue damage and necrosis

    • Why this specific test is needed and required

    ISO 10993-18 chemical characterization considering corrosion testing is necessary to evaluate the potential toxicity and corrosion of medical devices.

    Business and Technical Reasons

    The business and technical reasons for conducting ISO 10993-18 chemical characterization considering corrosion testing include:

  • To ensure product safety and performance

  • To reduce the risk of adverse events

  • To improve customer confidence and trust

  • To comply with regulatory requirements

    • Consequences of not performing this test

    Failure to perform ISO 10993-18 chemical characterization considering corrosion testing can result in:

  • Non-compliance with regulatory requirements

  • Product recalls or withdrawals

  • Loss of customer confidence and trust

  • Damage to business reputation

    • Industries and Sectors that Require this Testing

    The following industries and sectors require ISO 10993-18 chemical characterization considering corrosion testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Research institutions

    • Risk Factors and Safety Implications

    The risk factors and safety implications associated with medical devices include:

  • Toxicity and cytotoxicity

  • Corrosion and biodegradation

  • Infection and inflammation

  • Tissue damage and necrosis

    • Need help or have a question?
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