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iso-10993-18-chemical-characterization-considering-thermal-exposure
Thermal Resistance and Environmental Testing ASTM D1500 Heat Aging of Insulating MaterialsASTM D1929 Thermal Ignition of PolymersASTM D2240 Hardness Testing After Thermal ExposureASTM D2765 Thermal Stability of PolymersASTM D3039 Thermal Fatigue Testing of CompositesASTM D3045 Thermal Aging of PlasticsASTM D3895 Oxygen Index and Thermal StabilityASTM D3895 Thermal Degradation of PolymersASTM D4065 Dynamic Mechanical Thermal AnalysisASTM D412 Thermal Aging of ElastomersASTM D573 Heat Resistance of RubberASTM D618 Conditioning for Thermal AnalysisASTM D618 Conditioning of Plastics under Thermal ExposureASTM D648 Heat Deflection Temperature TestingASTM D648 Heat Deflection Testing of PlasticsASTM D695 Compressive Strength After Thermal ExposureASTM D746 Brittleness Temperature TestingASTM D785 Thermal Deformation TestingASTM D7945 Thermal Stability of CompositesASTM E595 Thermal Emission TestingASTM F1278 Thermal Cycling of Medical PolymersASTM F1576 Thermal Conductivity TestingASTM F1980 Accelerated Aging of Sterilized Medical DevicesASTM F1980 Accelerated Thermal Aging of Medical DevicesASTM F1981 Thermal Compatibility of Medical AdhesivesASTM F1983 Thermal Compatibility of MaterialsASTM F1984 Thermal Cycling of Sterilized ProductsASTM F2009 Thermomechanical Testing of DevicesASTM F2461 Thermal Performance of Medical Device CoatingsASTM F2477 Thermal Aging of Silicone ElastomersASTM F2516 Thermal Conductivity of Medical Device MaterialsASTM F2621 Thermal Expansion TestingASTM F3001 Thermal Endurance of ImplantsASTM F392 Thermal Resistance of Medical TubingIEC 60068-2-1 Cold Temperature TestingIEC 60068-2-11 Salt Fog with Thermal ExposureIEC 60068-2-14 Rapid Thermal Shock TestingIEC 60068-2-14 Thermal Shock Test MethodIEC 60068-2-14 Thermal Shock TestingIEC 60068-2-2 Dry Heat TestIEC 60068-2-20 Low Temperature and Thermal CyclingIEC 60068-2-30 Damp Heat, Cyclic (12+12 hour)IEC 60068-2-38 Dry Heat, Steady StateIEC 60068-2-4 Rapid Change of TemperatureIEC 60068-2-5 Combined Environmental Testing Including ThermalIEC 60068-2-78 Damp Heat, Steady StateIEC 60529 Environmental Protection Ratings and Thermal ImpactIEC 60529 Protection Against Environmental Thermal ConditionsIEC 60529 Protection Degree and Thermal ImpactIEC 60601-1 Medical Electrical Equipment Safety at Thermal LimitsIEC 60601-1 Thermal Safety RequirementsIEC 60601-1-11 Environmental Conditions for Medical Electrical EquipmentIEC 60601-1-11 Thermal Performance in Home Healthcare DevicesIEC 60601-1-2 Electromagnetic and Thermal ImmunityIEC 60601-1-8 Temperature Alarm SystemsIEC 60601-2-4 Temperature Limits for DefibrillatorsIEC 60749-23 Thermal Shock for Semiconductor DevicesISO 10993-1 Biological Evaluation Considering Thermal EffectsISO 10993-10 Sensitization Tests under Thermal ExposureISO 10993-10 Thermal Sensitization TestingISO 10993-11 Evaluation of Thermal Effects on Medical DevicesISO 10993-12 Sample Preparation with Thermal ConsiderationsISO 10993-4 Hemocompatibility Testing under Thermal StressISO 10993-5 Cytotoxicity Testing after Thermal ExposureISO 11135 Thermal Effects in Ethylene Oxide SterilizationISO 11135 Thermal Process Validation for EO SterilizationISO 11135-1 EO Gas Thermal Process MonitoringISO 11137-2 Thermal Validation of Sterilization CyclesISO 11137-3 Radiation Sterilization and Thermal EffectsISO 11607 Packaging Performance under Thermal StressISO 11607-2 Packaging System Validation under Thermal StressISO 13485 Quality Management Including Thermal ControlsISO 13485 Thermal Control in Manufacturing ProcessesISO 13485 Thermal Management in Medical Device ManufacturingISO 13485-1 Quality Systems and Thermal ControlsISO 13943 Fire Safety and Thermal Risk in DevicesISO 14644-1 Cleanroom Environmental MonitoringISO 14644-2 Thermal Stability in CleanroomsISO 14644-3 Cleanroom Testing and Thermal ConditionsISO 14644-4 Monitoring Thermal Conditions in CleanroomsISO 14698-1 Biocontamination Control Under Thermal ConditionsISO 14937 Thermal Process ValidationISO 14937 Thermal Validation of Sterilization ProcessesISO 14971 Risk Management for Thermal HazardsISO 14971 Thermal Risk ManagementISO 16750 Environmental Testing for Automotive Electrical EquipmentISO 16750 Environmental Tests Including Thermal CyclingISO 16750-4 Electrical Equipment Environmental Thermal TestingISO 16750-4 Environmental Testing for Electrical EquipmentISO 21789 Environmental Stress Testing for Medical Devices

ISO 10993-18 Chemical Characterization Considering Thermal Exposure Laboratory Testing Service: A Comprehensive Guide

The ISO 10993-18 standard is a part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices. This specific standard focuses on chemical characterization considering thermal exposure testing, which is essential for evaluating the potential biological risks associated with medical devices.

Relevant Standards

  • ISO 10993-1:2009(E) - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ISO 10993-17:2012 - Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances in medical devices

  • ISO 10993-18:2017(E) - Biological evaluation of medical devices Part 18: Chemical characterization considering thermal exposure

    • Legal and Regulatory Framework

    The ISO 10993 series is widely recognized as the international standard for biological evaluation of medical devices. Many countries have adopted this standard, and regulatory agencies require compliance with these guidelines to ensure product safety and efficacy.

  • EU Medical Device Regulation (EU) 2017/745: Requires manufacturers to comply with ISO 10993-1 and other relevant standards

  • FDA 21 CFR Part 820: Good Manufacturing Practice (GMP) for medical devices requires manufacturers to follow the ISO 10993 series

    • International and National Standards

    The standard is developed by Technical Committee 194 of the International Organization for Standardization (ISO), which includes representatives from various countries. Each country may have its own national standards, but these are often based on or aligned with international standards.

  • ASTM F748:2016 - Standard Practice for Selecting Balances and Weighing Equipment for Use in Testing and Inspection

  • EN ISO 10993-1:2009 - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing international standards. National standard development organizations, such as the American Society for Testing and Materials (ASTM), may also develop national standards that align with international guidelines.

  • ISO Technical Committee 194: Biological evaluation of medical devices

  • ASTM F44 Committee on Medical Devices

    • How Standards Evolve

    Standards evolve through a continuous process of review and revision. This involves input from experts, stakeholders, and regulatory agencies to ensure the standard remains relevant and effective.

  • ISO/TC 194/WG 1: Chemical characterization considering thermal exposure

  • ASTM F748 Subcommittee on Biocompatibility

    • Standard Numbers and Scope

    Each standard has a unique number and scope, which defines its focus and requirements. Understanding these standards is essential for ensuring compliance with regulatory requirements.

  • ISO 10993-18:2017(E) - Biological evaluation of medical devices Part 18: Chemical characterization considering thermal exposure

    • Scope: Evaluates the chemical properties of medical devices under various temperature conditions

    Standard Compliance Requirements

    Compliance with these standards is a requirement for many industries, including medical device manufacturers.

  • Medical Device Directive (MDD): EU MDR

  • FDA 21 CFR Part 820: GMP for medical devices

    • Standard-Related Information Conclusion

    The ISO 10993 series provides essential guidelines for the biological evaluation of medical devices. Compliance with these standards is a regulatory requirement, and understanding their scope and requirements is crucial for manufacturers.

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    Why This Test Is Needed and Required

    Medical device manufacturers must comply with regulatory requirements to ensure product safety and efficacy. The ISO 10993 series provides guidelines for the biological evaluation of medical devices, including chemical characterization considering thermal exposure testing.

  • Risk management: Manufacturers need to identify potential risks associated with their products

  • Regulatory compliance: Compliance with standards is a requirement for many industries

    • Business and Technical Reasons

    Conducting ISO 10993-18 Chemical Characterization Considering Thermal Exposure testing ensures product safety and efficacy. This test is essential for manufacturers who want to demonstrate their commitment to quality and regulatory compliance.

  • Business reasons: Manufacturers must comply with regulations to ensure market access

  • Technical reasons: Testing ensures product safety and efficacy

    • Consequences of Not Performing This Test

    Non-compliance with standards can result in significant consequences, including recalls, fines, and loss of business reputation.

  • Recalls: Products may be recalled if they do not meet regulatory requirements

  • Fines: Manufacturers may face fines for non-compliance with regulations

  • Loss of business reputation: Non-compliance can damage a companys reputation and credibility

    • Industries and Sectors That Require This Testing

    Many industries require compliance with the ISO 10993 series, including medical device manufacturers.

  • Medical devices: Manufacturers must comply with ISO 10993-18 to ensure product safety and efficacy

  • Pharmaceutical industry: Companies in this sector may also need to comply with standards related to biological evaluation

    • Standard Requirements and Needs Conclusion

    Manufacturers must comply with regulatory requirements, including the ISO 10993 series. Conducting ISO 10993-18 Chemical Characterization Considering Thermal Exposure testing ensures product safety and efficacy.

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    Standard Requirements and Needs: A Summary

    Standard Title Scope

    --- --- ---

    ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process Evaluates the biological risks associated with medical devices

    ISO 10993-17 Establishment of allowable limits for leachable substances in medical devices Provides guidelines for establishing allowable limits for leachable substances in medical devices

    ISO 10993-18 Chemical characterization considering thermal exposure Evaluates the chemical properties of medical devices under various temperature conditions

    A Closer Look at Standard Requirements and Needs

    The ISO 10993 series provides essential guidelines for the biological evaluation of medical devices. Compliance with these standards is a regulatory requirement, and understanding their scope and requirements is crucial for manufacturers.

  • ISO 10993-1:2009(E) - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Scope: Evaluates the biological risks associated with medical devices

  • ISO 10993-17:2012 - Establishment of allowable limits for leachable substances in medical devices

    • Scope: Provides guidelines for establishing allowable limits for leachable substances in medical devices

  • ISO 10993-18:2017(E) - Biological evaluation of medical devices Part 18: Chemical characterization considering thermal exposure

    • Scope: Evaluates the chemical properties of medical devices under various temperature conditions

    Standard Requirements and Needs Conclusion

    The ISO 10993 series provides essential guidelines for the biological evaluation of medical devices. Compliance with these standards is a regulatory requirement, and understanding their scope and requirements is crucial for manufacturers.

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    This comprehensive guide will cover all aspects of ISO 10993-18 Chemical Characterization Considering Thermal Exposure laboratory testing service, including standard-related information, standard requirements and needs, test procedure, equipment, and sample preparation.

    ISO 10993-18 Chemical Characterization Considering Thermal Exposure Laboratory Testing Service

    The ISO 10993-18 standard provides guidelines for the chemical characterization of medical devices under various temperature conditions. This testing is essential to evaluate the potential biological risks associated with medical devices.

  • Test Procedure

    • Sample preparation: Samples must be prepared according to specific guidelines

    Test equipment: Specialized test equipment is required for this testing

    Test procedure: The test procedure involves evaluating the chemical properties of medical devices under various temperature conditions

    Equipment Needed

    Specialized test equipment is required for ISO 10993-18 Chemical Characterization Considering Thermal Exposure laboratory testing service.

  • Thermal analyzer

    • Measures changes in material properties due to thermal exposure

  • Gas chromatograph (GC)

    • Analyzes volatile compounds released from medical devices

  • High-performance liquid chromatograph (HPLC)

    • Analyzes the chemical composition of medical devices

    Sample Preparation

    Sample preparation is a critical step in ISO 10993-18 Chemical Characterization Considering Thermal Exposure laboratory testing service.

  • Material selection: Selecting the correct sample material for testing

  • Preparation procedures: Preparing samples according to specific guidelines

  • Storage conditions: Storing samples under controlled temperature and humidity conditions

    • ISO 10993-18 Chemical Characterization Considering Thermal Exposure Laboratory Testing Service Conclusion

    The ISO 10993-18 standard provides essential guidelines for the chemical characterization of medical devices under various temperature conditions. Compliance with this standard is a regulatory requirement, and understanding its scope and requirements is crucial for manufacturers.

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    Please note that this is just a sample response, and you may need to modify it based on your specific requirements.

    Also, please keep in mind that this guide is not exhaustive, and you should consult the ISO 10993-18 standard and other relevant guidelines for detailed information.

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