EUROLAB
iso-10993-4-hemocompatibility-testing-under-thermal-stress
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 10993-18 Chemical Characterization Considering Thermal ExposureISO 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 10993-4 Hemocompatibility Testing under Thermal Stress Laboratory Testing Service Provided by Eurolab

Standard-Related Information

ISO 10993-4 is a standard for the biological evaluation of medical devices, specifically for hemocompatibility testing under thermal stress. This standard is part of the larger ISO 10993 series, which provides guidelines for the assessment of the safety and performance of medical devices.

The relevant standards that govern this testing service are:

  • ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

  • ASTM F748-13 Standard Practice for Selecting Generic Biological Tests for Materials and Devices

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

  • TSE (Turkish Standards Institution) equivalent standards

    • The legal and regulatory framework surrounding this testing service is primarily governed by the European Unions Medical Device Regulation (MDR), which requires manufacturers to demonstrate conformity with essential requirements for safety, performance, and clinical evaluation. National regulations in other countries, such as the United States FDA guidelines, also apply.

    Standard development organizations like ISO, ASTM, and EN have a significant role in developing and maintaining standards that ensure consistency and comparability of test results across different laboratories.

    Standards evolve through updates and revisions to reflect new scientific evidence, technological advancements, and changing regulatory requirements. For example, the current version of ISO 10993-4 (2017) supersedes the previous edition (2002).

    Standard Requirements and Needs

    The ISO 10993-4 standard specifies that hemocompatibility testing under thermal stress is necessary to evaluate the potential effects of a medical device on blood compatibility. This includes assessing the risk of thrombosis, embolism, and coagulation disorders.

    Business and technical reasons for conducting this test include:

  • Ensuring compliance with regulatory requirements

  • Preventing injuries or fatalities due to hemocompatibility issues

  • Enhancing product safety and reliability

  • Improving customer trust and confidence

  • Gaining a competitive advantage in the market

    • Consequences of not performing this test can be severe, including recalls, fines, and damage to reputation.

    Test Conditions and Methodology

    The testing service provided by Eurolab involves the following steps:

    1. Sample preparation: Collecting and preparing blood samples from donors for analysis.

    2. Testing equipment and instruments: Using calibrated and validated equipment to perform thermal stress tests, such as thermometers, heat exchangers, and spectrophotometers.

    3. Testing environment requirements: Maintaining precise temperature (37C 0.5C) and humidity control within the testing chamber.

    4. Measurement and analysis methods: Employing techniques like spectroscopy, chromatography, and microscopy to assess hemocompatibility effects.

    5. Calibration and validation procedures: Regularly calibrating equipment and validating test methods to ensure accuracy and precision.

    Test Reporting and Documentation

    The test report provided by Eurolab includes:

  • Introduction and background information

  • Methodology and testing conditions

  • Test results, including tables, figures, and graphs

  • Interpretation of results and conclusions drawn

  • Certification and accreditation details

    • Reports are structured according to international standards (e.g., ISO/IEC 17025) and documented in electronic format for secure sharing with customers.

    Why This Test Should Be Performed

    The benefits of performing this testing service include:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

  • Customer confidence and trust building

    • Why Eurolab Should Provide This Service

    Eurolab is an expert in this field, with:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details (e.g., ISO/IEC 17025)

  • International recognition and partnerships

  • Quality management systems and procedures

    • Eurolabs capabilities provide customers with:

  • Competitive pricing and value proposition

  • Technical support and consultation services

  • Turnaround time and efficiency advantages

    • Conclusion

    ISO 10993-4 Hemocompatibility Testing under Thermal Stress is a critical aspect of medical device testing, ensuring the safety and performance of devices that come into contact with blood. Eurolabs comprehensive testing service provides customers with reliable results, expert support, and compliance assurance.

    By selecting Eurolab for this laboratory testing service, companies can:

  • Enhance product safety and reliability

  • Improve customer trust and confidence

  • Gain a competitive advantage in the market

  • Ensure regulatory compliance and mitigate risks

    • Contact Eurolab today to learn more about our ISO 10993-4 Hemocompatibility Testing under Thermal Stress laboratory testing services.

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    References:

    1. ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.

    2. ASTM F748-13 Standard Practice for Selecting Generic Biological Tests for Materials and Devices.

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

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