EUROLAB
iso-11137-3-guidance-on-dosimetric-aspects-for-radiation-sterilization
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

Comprehensive Guide to ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization Testing Services Provided by Eurolab

ISO 11137-3 is an international standard that provides guidance on the dosimetric aspects of radiation sterilization. This standard is a critical component in ensuring the safety and efficacy of medical devices, pharmaceuticals, and other products that require radiation sterilization.

Overview of Relevant Standards

  • ISO 11137:2017 - Radiation sterilization - Dosimetry requirements for radiation processing in health care applications

  • ASTM E2500-16 - Standard Guide for Dosimetry for Radiation Processing of Materials

  • EN 552-1:2003 - Sterilisation by ionising radiation - Dose-setting and dose delivery to products within the scope of the standard

  • TSE ISO 11137-3:2022 - Radyasyon Sterilizasyonu - 1. Bölüm: Uygulama ve Yönetim Kılavuzu

    • Legal and Regulatory Framework Surrounding This Testing Service

    The legal and regulatory framework surrounding radiation sterilization is governed by international and national standards. These standards provide a framework for ensuring the safety and efficacy of products that require radiation sterilization.

  • International standards: ISO 11137-3, ASTM E2500-16

  • National standards: EN 552-1:2003 (EU), TSE ISO 11137-3:2022 (Turkey)

    • Standard Development Organizations and Their Role

    Standard development organizations play a critical role in developing and maintaining international and national standards. These organizations ensure that the standards are up-to-date, relevant, and meet the needs of industry stakeholders.

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • ENI (European Committee for Electrotechnical Standardization)

    • How Standards Evolve and Get Updated

    Standards evolve and get updated to reflect changes in technology, industry practices, and regulatory requirements. This ensures that the standards remain relevant and effective in ensuring safety and efficacy.

  • ISO 11137-3:2017 - Superseded by ISO 11137-3:2022

  • ASTM E2500-16 - Updated from ASTM E2500-12

    • Standard Compliance Requirements for Different Industries

    Industry compliance with standards is critical to ensure the safety and efficacy of products that require radiation sterilization. The following industries require standard compliance:

  • Medical devices

  • Pharmaceuticals

  • Food processing

  • Aerospace

    • Why This Specific Test Is Needed and Required

    The ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization testing is required to ensure the safety and efficacy of products that require radiation sterilization. The test provides a framework for ensuring that the radiation dose delivered to products meets the required standards.

    Business and Technical Reasons for Conducting This Test

    The business and technical reasons for conducting this test include:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining quality and consistency

  • Reducing risk and liability

    • Consequences of Not Performing This Test

    Not performing the ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization testing can result in:

  • Non-compliance with regulations

  • Risk to product safety and efficacy

  • Financial losses due to recalls, liabilities, and reputation damage

  • Loss of market share and competitive advantage

    • Industries and Sectors That Require This Testing

    The following industries require the ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization testing:

  • Medical devices

  • Pharmaceuticals

  • Food processing

  • Aerospace

    • Risk Factors and Safety Implications

    Radiation sterilization involves risks to product safety, worker safety, and environmental safety. The ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization testing helps mitigate these risks by ensuring that the radiation dose delivered meets the required standards.

  • Radiation exposure to workers

  • Contamination of products with radioactive materials

  • Environmental pollution from radioactive waste

    • Quality Assurance and Control Aspects

    The ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization testing is an essential component of quality assurance and control. The test ensures that the radiation dose delivered meets the required standards, which helps maintain product safety and efficacy.

  • Ensuring consistency and reliability

  • Reducing risk and liability

  • Maintaining regulatory compliance

    • How This Test Contributes to Product Safety and Reliability

    The ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization testing contributes to product safety and reliability by:

  • Ensuring that the radiation dose delivered meets the required standards

  • Reducing risk and liability

  • Maintaining regulatory compliance

    • Cost Savings and Competitive Advantage

    Conducting the ISO 11137-3 Guidance on Dosimetric Aspects for Radiation Sterilization testing can result in cost savings and a competitive advantage by:

  • Ensuring regulatory compliance

  • Reducing risk and liability

  • Maintaining quality and consistency

    • Eurolab offers radiation sterilization testing services that meet the requirements of ISO 11137-3. Our state-of-the-art facilities and expert technicians ensure that your products receive accurate and reliable results.

    Radiation Sterilization Capabilities

  • Gamma radiation

  • Electron beam radiation

  • X-ray radiation

    • Testing Services for Different Industries

    Eurolab provides testing services for a wide range of industries, including:

  • Medical devices

  • Pharmaceuticals

  • Food processing

  • Aerospace

    • Accreditation and Certifications

    Eurolab is accredited by national and international organizations, ensuring that our testing services meet the highest standards.

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

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

    • Why Choose Eurolab?

    Eurolab offers a range of benefits when it comes to radiation sterilization testing, including:

  • Expertise in radiation sterilization testing

  • State-of-the-art facilities and equipment

  • Fast turnaround times and competitive pricing

  • Excellent customer service and support

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

    CONTACT US +902127020000

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