EUROLAB
iso-11137-3-dosimetry-system-for-radiation-sterilization
Sterilization Validation AAMI ST41 Sterilization Biological IndicatorsAAMI TIR12 Guidelines on EO SterilizationAAMI TIR31 Sterilization Residue LimitsAAMI TIR33 Guidance for Sterilization ValidationANSI/AAMI ST79 Comprehensive Sterilization GuideASTM E2197 Surface Decontamination ValidationASTM E2500 Process ValidationASTM E3139 Sterilization Biological Indicator RecoveryASTM F1608 Biological Indicators for EO SterilizationASTM F1635 Validation of Steam Sterilization CyclesASTM F1929 Integrity Testing of Sterilization PackagingASTM F1960 EO Sterilization Residuals TestingASTM F1980 Accelerated Aging for Sterilized DevicesASTM F1980 Accelerated Aging of Sterilized DevicesASTM F1980 Shelf-Life Validation of Sterilized DevicesASTM F1983 Validation of Steam Sterilization ParametersASTM F1989 Validation of Sterilization BioburdenASTM F2096 Bubble Leak Testing for Sterile PackagesASTM F2118 Validation of Packaging Seal IntegrityASTM F2459 Sterilization Residuals AnalysisASTM F2500 Steam Sterilization Cycle EvaluationASTM F2759 Steam Sterilization Performance EvaluationEN 285 Large Steam Sterilizers ValidationEN 866 Sterilization Chemical IndicatorsEN 867 Biological Indicators for SterilizationEN ISO 11135-1 EO Gas Process ControlEN ISO 17665 Steam Sterilizer Equipment QualificationEN ISO 17665 Sterilization Steam ValidationISO 10993-12 Sample Preparation for Sterilization TestsISO 10993-7 Evaluation of Ethylene Oxide ResiduesISO 11135 EO Gas Sterilization Equipment QualificationISO 11135 Ethylene Oxide Sterilization ValidationISO 11135-1 EO Gas Sterilization Process ControlISO 11135-2 EO Sterilization Process MonitoringISO 11137 Radiation Process ValidationISO 11137 Radiation Sterilization DosimetryISO 11137 Radiation Sterilization ValidationISO 11138 Biological Indicators for Steam SterilizationISO 11607 Packaging Integrity TestingISO 11607-1 Packaging Material ValidationISO 11607-2 Packaging System ValidationISO 11737 Microbial Limit Testing for SterilizationISO 11737-1 Sterilization Microbiological MethodsISO 11737-2 Sterilization Sterility AssuranceISO 11737-3 Bioburden Testing and EvaluationISO 13408-1 Aseptic Processing ValidationISO 13408-2 Sterile Filtration ValidationISO 13485 Sterilization Equipment QualificationISO 13485 Sterilization Process ControlISO 13485 Sterilization Process QualityISO 13485 Sterilization Quality ManagementISO 14161 Sterilization Process ValidationISO 14162 Packaging for Sterilized Medical DevicesISO 14937 General Requirements for Sterilizer ValidationISO 14937 Sterilization Process Validation RequirementsISO 14971 Risk Management in SterilizationISO 14971 Sterilization Risk AssessmentISO 17665 Steam Sterilizer Performance TestingISO 17665-1 Steam Sterilization ValidationISO 17665-1 Sterilization Cycle DevelopmentISO 17665-2 Steam Sterilization Process Control

Comprehensive Guide to ISO 11137-3 Dosimetry System for Radiation Sterilization Testing Services by Eurolab

Standard-Related Information

ISO 11137-3 is a standard that governs the dosimetry system for radiation sterilization testing. This standard is part of the ISO 11137 series, which provides guidelines and requirements for achieving sterility assurance in medical devices and other products exposed to ionizing radiation.

The ISO 11137-3 standard specifies the requirements for the dosimetry system used in radiation sterilization processes. It outlines the principles and methods for calibrating, testing, and validating the dosimetry system to ensure accurate measurement of absorbed dose.

International Standards

  • ISO 11137-1:2018 - Sterilization of medical devices - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

  • ISO 11137-2:2018 - Sterilization of medical devices - Radiation - Part 2: Guidance on the selection of conditions for the processing of medical devices

  • ISO 11137-3:2019 - Sterilization of medical devices - Radiation - Part 3: Dosimetry system for radiation sterilization

  • ASTM E2659 - Standard Practice for Calibration and Testing of Dosimeters Used in Radiation Sterilization

    • Regulatory Framework

    The regulatory framework surrounding ISO 11137-3 is governed by international and national standards. These standards ensure that medical devices and other products are properly sterilized to prevent the spread of infection.

  • European Union: Directive 2014/53/EU - Radioactive Substances in Medical Devices

  • United States: FDA Code of Federal Regulations Title 21 Part 800 (Sterilization)

  • International Organization for Standardization (ISO)

    • Standard Development Organizations

    Standard development organizations, such as ISO and ASTM, play a crucial role in developing and updating standards related to radiation sterilization.

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

    • Evolution of Standards

    Standards evolve over time as new technologies and research become available. This ensures that the standards remain relevant and effective in ensuring product safety and quality.

    Standard Numbers and Scope

    The following standard numbers and their scope are relevant to ISO 11137-3:

  • ISO 11137-1:2018 - Sterilization of medical devices - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

  • ISO 11137-2:2018 - Sterilization of medical devices - Radiation - Part 2: Guidance on the selection of conditions for the processing of medical devices

  • ISO 11137-3:2019 - Sterilization of medical devices - Radiation - Part 3: Dosimetry system for radiation sterilization

    • Standard Compliance Requirements

    Standard compliance requirements vary depending on industry and sector. The following industries require compliance with ISO 11137-3:

  • Medical device manufacturers

  • Pharmaceuticals

  • Food processing

    • Standard-Related Costs

    The costs associated with standard compliance can be significant, but they are essential for ensuring product safety and quality.

    Standard-Related Benefits

    Compliance with ISO 11137-3 provides several benefits, including:

  • Improved product safety and reliability

  • Enhanced customer confidence and trust

  • Increased market access and trade facilitation

    • Standard-Related Risks

    Non-compliance with ISO 11137-3 can result in significant risks, including:

  • Product failure and recalls

  • Regulatory fines and penalties

  • Damage to reputation and brand image

    • Standard-Related Training and Education

    Training and education are essential for ensuring compliance with ISO 11137-3. Eurolab provides training and education programs to help customers understand the requirements of this standard.

    Standard-Related Certifications and Accreditation

    Eurolab is certified to ISO 17025:2018 by a recognized certification body, ensuring that our testing services meet international standards for quality and competence.

    Business and Technical Reasons for Conducting ISO 11137-3 Testing

    The business and technical reasons for conducting ISO 11137-3 testing include:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements

  • Enhancing customer confidence and trust

  • Increasing market access and trade facilitation

    • Quality Assurance and Quality Control Aspects

    Quality assurance and quality control aspects are essential for ensuring compliance with ISO 11137-3.

  • Test Conditions and Methodology

    • Eurolabs testing services for ISO 11137-3 include:

  • Sample Preparation: Samples are prepared according to the standard requirements.

  • Testing Equipment and Instruments: Eurolab uses state-of-the-art equipment and instruments, including dosimeters calibrated in accordance with ASTM E2659.

  • Testing Environment Requirements: The testing environment is controlled to ensure accurate measurement of absorbed dose.

  • Data Analysis and Reporting: Data analysis and reporting are performed according to the standard requirements.

    • Test Report

    The test report includes:

  • Summary of Test Results: A summary of the test results, including any deviations from the expected results.

  • Conclusion and Recommendation: A conclusion and recommendation for future testing based on the test results.

    • Data Analysis and Reporting

    Eurolab performs data analysis and reporting in accordance with ISO 11137-3 requirements.

  • Absorbed Dose Measurement: The absorbed dose is measured using a dosimeter calibrated in accordance with ASTM E2659.

  • Radiation Field Mapping: Radiation field mapping is performed to ensure accurate measurement of absorbed dose.

  • Data Analysis: Data analysis is performed to determine the absorbed dose and any deviations from the expected results.

    • Testing Services

    Eurolab provides testing services for ISO 11137-3, including:

  • Calibration and Testing of Dosimeters

  • Radiation Field Mapping

  • Data Analysis and Reporting

    • Conclusion

    ISO 11137-3 is a critical standard for ensuring product safety and quality in medical devices and other products exposed to ionizing radiation. Compliance with this standard requires accurate measurement of absorbed dose using a dosimetry system calibrated in accordance with ASTM E2659. Eurolabs testing services meet international standards for quality and competence, ensuring that customers receive reliable and accurate results.

    References

  • ISO 11137-1:2018 - Sterilization of medical devices - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

  • ISO 11137-2:2018 - Sterilization of medical devices - Radiation - Part 2: Guidance on the selection of conditions for the processing of medical devices

  • ISO 11137-3:2019 - Sterilization of medical devices - Radiation - Part 3: Dosimetry system for radiation sterilization

  • ASTM E2659 - Standard Practice for Calibration and Testing of Dosimeters Used in Radiation Sterilization

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