EUROLAB
iso-11137-radiation-sterilization-validation
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 11137-3 Dosimetry System for Radiation SterilizationISO 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 Radiation Sterilization Validation Laboratory Testing Service Provided by Eurolab

ISO 11137 is an international standard for the validation of radiation sterilization processes, which ensures that products are effectively sterilized without compromising their quality or safety. This standard is widely accepted and adopted globally, and its implementation is mandatory for certain industries.

The relevant standards governing ISO 11137 Radiation Sterilization Validation testing include:

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

  • ISO 11137-2:2018 - Sterilization of health care products -- Radiation -- Part 2: Guidance on the application of the ISO 11137-1

  • ASTM E1704-19 - Standard Practice for Dosimetry in Radiation Research on Living Tissues and Other Materials

  • EN 552-1:2009 - Medical electrical equipment - Sterilization of medical instruments by ionizing radiation

  • TSE (Turkish Standards Institution) EN ISO 11137-1:2018

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

  • European Unions Medical Device Regulation (MDR)

  • US FDAs 21 CFR Part 876 - Medical Devices

  • International Organization for Standardization (ISO) standards

  • Turkish Standards Institution (TSE)

    • International and national standards that apply to this specific laboratory test include ISO 11137-1, ISO 11137-2, ASTM E1704-19, EN 552-1:2009, and TSE EN ISO 11137-1:2018.

    Standard development organizations, such as the International Organization for Standardization (ISO), play a crucial role in developing and maintaining standards. These organizations collaborate with experts from various industries to ensure that standards are relevant, effective, and up-to-date.

    Standards evolve over time to reflect advancements in technology, changes in regulations, and emerging best practices. Eurolab stays abreast of these developments to ensure that our testing services meet the latest requirements.

    Standard compliance is essential for different industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Food processing industries

  • Aerospace and defense sectors

    • Compliance with standards ensures that products are safe, effective, and meet regulatory requirements.

    ISO 11137 Radiation Sterilization Validation testing is required to ensure the safety and effectiveness of medical instruments and other products sterilized using ionizing radiation. This test is necessary for several reasons:

  • Business and technical reasons: The test provides a scientific basis for establishing radiation sterilization processes, ensuring that products are effectively sterilized without compromising their quality or safety.

  • Consequences of not performing the test: Without this testing, there is a risk of product contamination, which can lead to adverse health effects, recalls, and damage to reputation.

  • Industries requiring this testing: Medical device manufacturers, pharmaceutical companies, food processing industries, aerospace and defense sectors.

    • Risk factors associated with radiation sterilization include:

  • Radiation exposure

  • Contamination

  • Inadequate sterilization

    • This test contributes to product safety and reliability by ensuring that products are effectively sterilized using ionizing radiation. Quality assurance and quality control aspects of this testing include:

  • Quality management systems: Eurolab has implemented a comprehensive quality management system to ensure the accuracy, precision, and reliability of our testing services.

  • Calibration and validation procedures: We perform regular calibration and validation of our equipment to ensure that it meets the latest standards.

    • The competitive advantages of having this testing performed include:

  • Compliance with regulations: By performing this test, companies can demonstrate compliance with international and national regulations.

  • Product safety and reliability: The test ensures that products are safe and reliable for use by consumers.

  • Cost savings: Performing this test can reduce the risk of product contamination, recalls, and damage to reputation.

    • The ISO 11137 Radiation Sterilization Validation testing process involves several steps:

    1. Sample preparation: The sample is prepared according to the standard requirements.

    2. Testing equipment and instruments: We use state-of-the-art equipment, including gamma radiation sources and dosimeters.

    3. Testing environment requirements: The test is performed in a controlled environment with precise temperature, humidity, and pressure conditions.

    4. Measurement and analysis methods: The sample is exposed to ionizing radiation, and the sterilization process is monitored using dosimetry techniques.

    The testing parameters and conditions include:

  • Radiation dose rate: We measure the radiation dose rate to ensure that it meets the standard requirements.

  • Exposure time: The exposure time is carefully controlled to ensure effective sterilization without compromising product quality or safety.

    • The calibration and validation procedures involve regular checks on our equipment to ensure that it meets the latest standards. Our experienced technicians perform these checks using standardized protocols.

    Eurolabs Testing Process

    Our testing process involves several stages, including:

    1. Sample preparation: We receive samples from clients, which are then prepared according to standard requirements.

    2. Testing: The sample is exposed to ionizing radiation, and the sterilization process is monitored using dosimetry techniques.

    3. Data analysis: We analyze the data collected during the test to determine whether the product has been effectively sterilized.

    Conclusion

    ISO 11137 Radiation Sterilization Validation testing is essential for ensuring the safety and effectiveness of products sterilized using ionizing radiation. Eurolabs comprehensive quality management system, calibration and validation procedures, and state-of-the-art equipment ensure that our testing services meet the latest standards. By performing this test, companies can demonstrate compliance with international and national regulations, reduce the risk of product contamination, recalls, and damage to reputation, and enhance product safety and reliability.

    Eurolabs Contact Information

    For more information on our ISO 11137 Radiation Sterilization Validation testing services, please contact us at:

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Phone: 1 (800) 123-4567

    Address: Eurolab Inc., 123 Main St, Anytown, USA.

    We look forward to assisting you with your testing needs.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers