EUROLAB
iso-11737-1-bioburden-determination-on-medical-devices
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 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 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 11737-2 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 11737-1 Bioburden Determination on Medical Devices Laboratory Testing Service by Eurolab

ISO 11737-1 is a widely recognized international standard that governs the bioburden determination of medical devices. The standard, published by the International Organization for Standardization (ISO), provides a framework for testing and evaluating the presence of microorganisms on medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 11737-1 Bioburden Determination on Medical Devices testing is governed by various international, national, and industry-specific regulations. Some of the key regulations include:

  • EU Medical Device Regulation (MDR) 2017/745

  • US FDA Guidance for Industry: Sterility Testing (2015)

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

    • International and National Standards

    The following standards are relevant to ISO 11737-1 Bioburden Determination on Medical Devices testing:

  • ISO 11737-2:2018 (Sterilization of medical instruments and equipment. Microbiological removal by appropriate sterilization processes)

  • ASTM F1473-08 (Standard Practice for Selecting Sterilization Conditions for Medical Products)

    • Standard Development Organizations

    The following organizations play a crucial role in developing and maintaining standards related to ISO 11737-1 Bioburden Determination on Medical Devices testing:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Updates

    Standards evolve over time, and new versions are published to reflect changes in technology, regulations, or industry practices. Eurolab ensures that its testing services comply with the latest standards and updates.

    Specific Standard Numbers and Scope

    Some of the relevant standard numbers and their scope include:

  • ISO 11737-1:2018 (Biological evaluation of medical devices Part 1: Evaluation of biological effects)

  • ISO 10993-5:2009 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity)

    • Industry-Specific Standard Compliance Requirements

    Different industries have specific compliance requirements for bioburden determination on medical devices. For example:

  • Medical devices manufacturers must comply with EU MDR 2017/745 and US FDA Guidance for Industry: Sterility Testing (2015)

  • Pharmaceutical companies may require compliance with ISO 11737-2:2018

    • Why is this specific test needed and required?

    Bioburden determination on medical devices is essential to ensure the safety and efficacy of these products. Medical devices can harbor microorganisms, which can lead to contamination, infection, or even death.

    Business and Technical Reasons for Conducting ISO 11737-1 Bioburden Determination on Medical Devices Testing

    Conducting bioburden determination on medical devices is crucial for several reasons:

  • Ensures product safety and reliability

  • Complies with regulatory requirements

  • Demonstrates quality assurance and compliance

  • Enhances customer confidence and trust

    • Consequences of not performing this test

    Failure to perform bioburden determination on medical devices can have severe consequences, including:

  • Contamination and infection risks

  • Product recalls and liability issues

  • Damage to reputation and brand image

    • Industries and Sectors that require this testing

    The following industries and sectors require bioburden determination on medical devices:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Hospitals and healthcare institutions

  • Government agencies and regulatory bodies

    • Risk Factors and Safety Implications

    Bioburden determination on medical devices is critical to mitigate the risk of contamination, infection, or other safety-related issues.

    Quality Assurance and Quality Control Aspects

    Eurolabs testing services ensure that bioburden determination on medical devices meets the highest quality standards and complies with regulatory requirements.

    Step-by-Step Explanation of How the Test is Conducted

    The following steps outline the process for conducting bioburden determination on medical devices:

    1. Sample preparation

    2. Testing equipment and instruments used

    3. Testing environment requirements

    4. Measurement and analysis methods

    5. Calibration and validation procedures

    6. Quality control measures during testing

    Testing Equipment and Instruments Used

    Eurolab uses state-of-the-art equipment and instruments to conduct bioburden determination on medical devices, including:

  • Microbiological analyzers (e.g., qPCR)

  • Incubators and sterilization units

  • Sampling and preparation equipment (e.g., sterile loops, Petri dishes)

    • Testing Environment Requirements

    The testing environment for bioburden determination on medical devices must meet specific requirements, including:

  • Temperature control (e.g., incubation at 37C 2C)

  • Humidity control (e.g., 50 5)

  • Cleanliness and sterilization protocols

    • Measurement and Analysis Methods

    Eurolab uses standardized measurement and analysis methods to determine bioburden on medical devices, including:

  • Microbiological culturing

  • qPCR-based detection

  • Sterility testing

    • Calibration and Validation Procedures

    Eurolab ensures that its equipment and instruments are calibrated and validated regularly to ensure accurate results.

    Quality Control Measures During Testing

    Eurolab implements quality control measures during testing, including:

  • Operator training and certification

  • Equipment maintenance and calibration schedules

  • Documented procedures for sampling, handling, and storage of samples

    • Conclusion

    In conclusion, bioburden determination on medical devices is a critical aspect of ensuring product safety and efficacy. Eurolabs comprehensive guide provides an in-depth understanding of the standard requirements, test conditions, and methodology involved in conducting this testing.

    References

  • ISO 11737-1:2018 (Biological evaluation of medical devices Part 1: Evaluation of biological effects)

  • ISO 10993-5:2009 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity)

  • EU MDR 2017/745

  • US FDA Guidance for Industry: Sterility Testing (2015)

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