EUROLAB
iso-11137-3-radiation-sterilization-and-thermal-effects
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 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

Comprehensive Guide to ISO 11137-3 Radiation Sterilization and Thermal Effects Testing Services

Introduction

Radiation sterilization is a widely used method for ensuring the sterility of medical devices, pharmaceuticals, and other products. The International Organization for Standardization (ISO) has established guidelines for radiation sterilization, specifically ISO 11137-3, which outlines the requirements for evaluating the effects of radiation on materials and products. This article provides an in-depth guide to the ISO 11137-3 testing services offered by Eurolab, covering standard-related information, standard requirements and needs, test conditions and methodology, test reporting and documentation, and why this service should be performed.

ISO 11137-3 is a part of the ISO 11137 series, which sets out guidelines for radiation sterilization. The standard specifies the requirements for evaluating the effects of radiation on materials and products to ensure that they are sterile after irradiation. The standard also provides guidance on the selection of materials and products for radiation sterilization.

Relevant Standards

  • ISO 11137-1:2019 - Radiation Sterilization - Part 1: General principles

  • ISO 11137-2:2019 - Radiation Sterilization - Part 2: Validation requirements for radiation processing

  • ISO 11137-3:2019 - Radiation Sterilization - Part 3: Monitoring and control of sterilizing dose

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding radiation sterilization is governed by various national and international standards. In the European Union, for example, the Medical Device Regulation (MDR) requires that medical devices undergo radiation sterilization to ensure their safety and effectiveness.

    Standard Development Organizations

    Standards development organizations such as ISO, ASTM, EN, TSE, and others play a crucial role in establishing guidelines for radiation sterilization. These organizations work collaboratively with industry experts, regulatory bodies, and other stakeholders to develop standards that meet the needs of various industries.

    International and National Standards

    International standards, such as ISO 11137-3, are adopted by national standards organizations, which may modify or add to them to suit their specific requirements. For example, in the United States, the FDA requires that medical devices undergo radiation sterilization in accordance with ASTM E1028-14.

    Standard Compliance Requirements

    Compliance with international and national standards is essential for industries that require radiation sterilization. Failure to comply can result in product recalls, regulatory penalties, or even lawsuits.

    Standard Development Process

    Standards are developed through a collaborative process involving industry experts, regulatory bodies, and other stakeholders. The development process involves:

    1. Identifying the need for a standard

    2. Conducting research and gathering data

    3. Drafting the standard

    4. Reviewing and revising the draft

    5. Approving the final standard

    Standard Update Process

    Standards are regularly updated to reflect changes in technology, industry practices, or regulatory requirements. Updates may involve:

    1. Revising existing standards

    2. Issuing new standards

    3. Canceling outdated standards

    Standard Numbers and Scope

    ISO 11137-3 specifies the requirements for evaluating the effects of radiation on materials and products. The standard provides guidelines for selecting materials and products, determining sterilizing doses, monitoring and controlling irradiation processes, and validating radiation processing.

    Industry-Specific Examples and Case Studies

  • Medical devices: ISO 11137-3 is widely used in the medical device industry to ensure that products are sterile after irradiation.

  • Pharmaceutical products: Radiation sterilization is used to sterilize pharmaceutical products, such as injectables and tablets.

  • Food and beverages: Radiation sterilization is used to sterilize food and beverages, such as packaged foods and beverages.

    • Why this Test is Needed

    Radiation sterilization is a critical process in various industries. The test is needed to ensure that products are sterile after irradiation and meet regulatory requirements.

    Business and Technical Reasons for Conducting ISO 11137-3 Testing

    Conducting ISO 11137-3 testing ensures compliance with international and national standards, reduces the risk of product recalls, and maintains customer trust.

    Consequences of Not Performing this Test

    Failure to perform this test can result in product contamination, regulatory penalties, or even lawsuits.

    Industries and Sectors that Require this Testing

    The medical device industry, pharmaceutical products, food and beverages, and other industries require radiation sterilization.

    Risk Factors and Safety Implications

    Radiation sterilization involves risks such as radiation exposure, contamination, and equipment failure. Ensuring compliance with international and national standards reduces these risks.

    Quality Assurance and Quality Control Aspects

    ISO 11137-3 testing ensures that products meet regulatory requirements and industry standards for radiation sterilization.

    Competitive Advantages of Having this Testing Done

    Conducting ISO 11137-3 testing provides a competitive advantage by ensuring compliance with international and national standards, reducing the risk of product recalls, and maintaining customer trust.

    Monitoring and Control of Sterilizing Dose

    ISO 11137-3 specifies the requirements for monitoring and controlling sterilizing doses to ensure that products are sterile after irradiation.

    Validation Requirements for Radiation Processing

    The standard provides guidelines for validating radiation processing, including determining sterilizing doses and monitoring and controlling irradiation processes.

    Reporting Requirements

    ISO 11137-3 specifies the requirements for reporting test results, including:

    1. Providing a detailed report of the testing process

    2. Including data on sterilizing doses, radiation levels, and product characteristics

    3. Specifying any deviations from standard procedures

    Documentation Requirements

    The standard requires that all documentation, including test reports and records, be accurate, complete, and legible.

    Benefits of Radiation Sterilization

    Radiation sterilization provides several benefits, including:

    1. Ensuring product sterility

    2. Reducing the risk of contamination

    3. Maintaining customer trust

    4. Complying with international and national standards

    Cost-Effectiveness

    Conducting ISO 11137-3 testing is cost-effective in the long run by reducing the risk of product recalls, regulatory penalties, or even lawsuits.

    Conclusion

    In conclusion, radiation sterilization is a critical process that requires compliance with international and national standards. Conducting ISO 11137-3 testing ensures that products are sterile after irradiation and meets regulatory requirements. The test provides several benefits, including ensuring product sterility, reducing the risk of contamination, maintaining customer trust, and complying with international and national standards.

    Eurolabs Expertise in Radiation Sterilization

    Eurolab has extensive experience in radiation sterilization, providing a range of services, including:

    1. Testing and certification

    2. Consulting and auditing

    3. Training and workshops

    Contact Eurolab to learn more about our expertise in radiation sterilization and how we can help you meet your testing requirements.

    References

  • ISO 11137-3:2019 - Radiation Sterilization - Part 3: Monitoring and control of sterilizing dose

  • ASTM E1028-14 - Standard Practice for Estimating the Effective Dose from Gamma Irradiation

  • FDA Guidance Document on Radiation Sterilization

    • This comprehensive guide has provided an in-depth overview of ISO 11137-3 testing services, including standard-related information, standard requirements and needs, test conditions and methodology, test reporting and documentation, and why this service should be performed. Eurolab is committed to providing expert guidance and support for radiation sterilization testing and certification.

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