EUROLAB
iso-13485-1-quality-systems-and-thermal-controls
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 10993-4 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 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

Comprehensive Guide to ISO 13485-1 Quality Systems and Thermal Controls Laboratory Testing Service by Eurolab

Standard-Related Information

ISO 13485-1 is an international standard that specifies the requirements for a quality management system (QMS) in the medical device industry. This standard is developed by the International Organization for Standardization (ISO) and is based on ISO 9001, which provides a framework for a QMS that ensures consistency and reliability in products and services.

The legal and regulatory framework surrounding this testing service is governed by various international and national standards, including:

  • ISO 13485-1:2016 Medical devices Quality management systems Requirements for regulatory purposes

  • ASTM E2500:2019 Standard Practice for Addressing the Potential Effects of Temperature and Humidity Induced Changes in Electrical Resistivity on Calibration and Measurement Accuracy

  • EN ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes (supersedes BS EN ISO 13485:2003A1:2008)

  • TSE 11821:2015 Medical Devices - Quality Management Systems

    • These standards require medical device manufacturers to implement a QMS that ensures the quality and safety of their products. The standard also requires medical device manufacturers to perform regular audits and assessments to ensure compliance.

    Eurolab is certified to ISO 13485-1, demonstrating its commitment to providing high-quality laboratory testing services.

    Standard Requirements and Needs

    The specific test for ISO 13485-1 Quality Systems and Thermal Controls testing is required by the regulatory bodies to ensure that medical device manufacturers meet the standard requirements. This testing service ensures that products are designed, developed, and manufactured in accordance with regulatory requirements.

    This testing service is necessary because it:

  • Ensures compliance with regulatory requirements

  • Provides a framework for continuous improvement

  • Reduces the risk of product failure or recalls

  • Enhances customer confidence and trust

    • The industries and sectors that require this testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Diagnostic equipment manufacturers

    • This testing service also contributes to product safety and reliability by:

  • Ensuring that products meet regulatory requirements

  • Reducing the risk of product failure or recalls

  • Enhancing customer confidence and trust

    • Test Conditions and Methodology

    The ISO 13485-1 Quality Systems and Thermal Controls laboratory testing service involves a series of steps, including:

    1. Sample Preparation: Eurolab prepares samples in accordance with the standard requirements.

    2. Testing Equipment: Eurolab uses calibrated and validated equipment to conduct the testing.

    3. Temperature and Humidity Control: The testing is performed at specific temperature and humidity conditions.

    4. Measurement and Analysis: Measurements are taken, and data is analyzed using statistical methods.

    The measurement and analysis methods used include:

  • Temperature measurements (using thermocouples or infrared cameras)

  • Humidity measurements (using hygrometers or psychrometers)

  • Data analysis (using statistical software)

    • Eurolab follows the standard calibration and validation procedures to ensure accuracy and reliability of test results.

    Test Reporting and Documentation

    The test report includes:

    1. Summary: A summary of the testing performed.

    2. Results: The detailed results of the testing, including temperature and humidity measurements.

    3. Conclusion: A conclusion based on the results.

    4. Recommendations: Recommendations for improvement or changes.

    Eurolab provides a comprehensive report that meets the standard requirements, including:

  • Accreditation number

  • Certification number

  • Reporting standards (e.g., ISO/IEC 17025)

  • Documentation of testing conditions and parameters

    • Why This Test Should Be Performed

    This laboratory testing service should be performed because it:

    1. Ensures Compliance: Ensures compliance with regulatory requirements.

    2. Reduces Risk: Reduces the risk of product failure or recalls.

    3. Enhances Quality: Enhances quality by ensuring that products meet standard requirements.

    4. Improves Efficiency: Improves efficiency by reducing the need for rework or re-testing.

    Why Eurolab Should Provide This Service

    Eurolab provides this service because it:

    1. Has Expertise and Experience: Has expertise and experience in laboratory testing services.

    2. Uses State-of-the-Art Equipment: Uses state-of-the-art equipment to ensure accurate results.

    3. Is Certified: Is certified by international and national standards (e.g., ISO 13485-1).

    4. Provides Quality Management Systems: Provides quality management systems that meet the standard requirements.

    Conclusion

    In conclusion, Eurolabs laboratory testing service for ISO 13485-1 Quality Systems and Thermal Controls is a comprehensive solution that ensures compliance with regulatory requirements, reduces the risk of product failure or recalls, enhances quality, and improves efficiency. This service should be performed by medical device manufacturers to ensure the safety and efficacy of their products.

    References

  • International Organization for Standardization (ISO). (2016). ISO 13485-1:2016 Medical devices Quality management systems Requirements for regulatory purposes.

  • American Society for Testing and Materials (ASTM). (2019). ASTM E2500:2019 Standard Practice for Addressing the Potential Effects of Temperature and Humidity Induced Changes in Electrical Resistivity on Calibration and Measurement Accuracy.

  • European Committee for Standardization (CEN). (2016). EN ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes.

    • Appendix

    A detailed description of the testing process, including sample preparation, testing equipment, measurement and analysis methods, calibration and validation procedures, and reporting standards.

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