EUROLAB
iso-11737-2-sterility-assurance-and-bioburden-control
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsAATCC TM100 Test for Antimicrobial Activity of TextilesANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical DevicesASTM D4414 Bioburden in Coated TextilesASTM D7295 Bioburden Testing on Coated Medical TextilesASTM E2314 Bioburden Testing in Medical Device ComponentsASTM E2406 Real-Time Endotoxin Detection Method ValidationASTM E2614 Bioburden in Industrial Water SystemsASTM E2883 Rapid Endotoxin Detection for Sterile PharmaceuticalsASTM F1608 Bacterial Filtration and Bioburden in Respiratory Protection DevicesASTM F1980 Bioburden Evaluation in Accelerated Aged ProductsASTM F2018 Endotoxin Testing of Contact Lens Care ProductsASTM F640 Bioburden Testing for Surgical DrapesEN 556 Sterilization of Medical Devices – Bioburden LimitsEN ISO 20857 Bioburden Control for Liquid Chemical SterilantsEP 2.6.1 Microbial Testing in Topical PreparationsEP 2.6.12 Microbial Limits Tests for Non-Sterile ProductsEP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical PreparationsEP 2.6.25 Limulus Amebocyte Lysate Test Methods ValidationEP 2.6.30 Endotoxin Testing in Biotechnology ProductsEP 2.6.31 Limulus Amebocyte Lysate Test for EndotoxinsEP 5.1.10 Guidelines for Bioburden Testing in Advanced Therapy Medicinal ProductsEP 5.1.2 Biological Indicators for Sterilization Process ControlEP Monograph 04/2013:20619 Pyrogen and Endotoxin TestingFDA CBER Guidance on Endotoxin Testing of VaccinesFDA CDER Guidance on Bioburden Control in Drug ManufacturingFDA Guidance for Industry on Pyrogen and Endotoxin TestingISO 10993-1 Biological Evaluation of Medical Devices – Endotoxin AssessmentISO 10993-18 Bioburden Interaction with Extractables and LeachablesISO 11137-2 Sterilization Process Validation and Bioburden TestingISO 11138-1 Biological Indicators for Sterilization – Bioburden EvaluationISO 11139 Sterilization Terminology and Bioburden DefinitionsISO 11607 Packaging for Terminally Sterilized Medical Devices – Bioburden ConsiderationsISO 11607-2 Packaging for Terminal Sterilized Devices – Bioburden ConsiderationsISO 11731 Detection of Legionella in Water SystemsISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-1 Bioburden on Reusable Surgical InstrumentsISO 11737-1 Bioburden Testing for Dental ImplantsISO 11737-2 Bioburden Testing for Sterile Barrier SystemsISO 13408-1 Aseptic Processing Bioburden ControlISO 13408-2 Aseptic Processing Microbiological MonitoringISO 14160 Endotoxin Removal Validation for Sterile LiquidsISO 14161 Bioburden Reduction Using FiltrationISO 14161 Validation of Bioburden Testing MethodsISO 14698-1 Cleanroom Biocontamination Control and MonitoringISO 14971 Risk Management of Endotoxin Contamination in Medical DevicesISO 15883-1 Bioburden Testing for Washer-DisinfectorsISO 17665-1 Moist Heat Sterilization – Bioburden ValidationISO 18562-1 Evaluation of Bioburden in Medical Devices – Part 1ISO 18562-4 Bioburden Testing in Medical Device Gas PathwaysISO 22519 Ultrafiltration Bioburden Reduction TestingISO 29621 Microbiological Examination of CosmeticsISO 80369-1 Endotoxin Limits for Small-Bore ConnectorsISO 80369-7 Small Bore Connectors Bioburden EvaluationISPE Baseline Guide Volume 7 Bioburden Control in Biopharmaceutical ManufacturingJP 15.02 Endotoxin Limit Test for Dialysis FluidsJP 4.05 Bacterial Endotoxin Test for Parenteral DrugsJP 4.06 Bacterial Endotoxin Testing of BiopharmaceuticalsJP XVII Limulus Amebocyte Lysate (LAL) Gel-Clot Test for EndotoxinsPh. Eur. Recombinant Factor C Assay for Endotoxin DetectionUSP <1050> Environmental Monitoring and Bioburden ControlUSP <1072> Disinfectants and Bioburden Control in Healthcare SettingsUSP <1111> Total Viable Count for Raw MaterialsUSP <1223> Rapid Endotoxin Test Method ValidationUSP <1223> Validation of Alternative Microbiological MethodsUSP <1225> Validation of Analytical Procedures for Endotoxin TestingUSP <1227> Validation of Microbial Recovery MethodsUSP <1229.10> Bioburden Testing in Steam SterilizationUSP <1229.12> Endotoxin Risk Assessment in Sterile ManufacturingUSP <1229.4> Microbial Testing for Aseptic Manufacturing EnvironmentsUSP <1229.9> Bioburden Validation in Isolator TechnologyUSP <1231> Bioburden Limits in Purified Water SystemsUSP <1231> Water for Pharmaceutical Purposes Microbial LimitsUSP <1232> Elemental Impurities and Bioburden ImpactUSP <61> Microbial Enumeration Test for Sterile ProductsUSP <61> Microbial Load Test for Oral Dosage FormsUSP <62> Test for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing for Ophthalmic ProductsUSP <800> Bioburden Control in Hazardous Drug CompoundingUSP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical ProductsWHO TRS 1003 Endotoxin Testing Validation for Parenteral Products

ISO 11737-2 Sterility Assurance and Bioburden Control Laboratory Testing Service Provided by Eurolab: A Comprehensive Guide

The ISO 11737-2 standard is a critical component of the sterility assurance and bioburden control testing process. This standard, developed by the International Organization for Standardization (ISO), provides guidelines for the evaluation of sterilization processes in medical devices.

Understanding the Legal and Regulatory Framework

In many countries, medical device manufacturers are required to comply with regulations that ensure their products meet specific standards for sterility and bioburden control. The ISO 11737-2 standard is widely adopted and recognized as a key reference document for these regulatory requirements.

International and National Standards Applicable to ISO 11737-2

The following international and national standards are relevant to the ISO 11737-2 testing service:

  • ISO 11138 (Sterilization of medical devices - Requirements for validation and routine control of sterilization)

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

  • FDA 21 CFR Part 820 (Quality system regulation)

  • EU MDR (Medical Devices Regulation)

    • Standard Development Organizations and Their Role

    The ISO is a non-profit organization that develops and publishes international standards. Other standard development organizations, such as ASTM International, EN 13485, and TSE, also contribute to the development of relevant standards for medical devices.

    How Standards Evolve and Get Updated

    Standards are regularly reviewed and updated to reflect new technologies, scientific advancements, and regulatory requirements. The ISO 11737-2 standard is subject to periodic review and revision to ensure it remains relevant and effective in ensuring product safety and reliability.

    Specific Standard Numbers and Their Scope

    The following standard numbers are applicable to the ISO 11737-2 testing service:

  • ISO 11138:2017 (Sterilization of medical devices Requirements for validation and routine control of sterilization)

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

    • Standard Compliance Requirements for Different Industries

    Compliance with the ISO 11737-2 standard is mandatory for medical device manufacturers operating in various industries, including:

  • Medical devices

  • Pharmaceutical products

  • Biotechnology products

    • Consequences of Non-Compliance

    Failure to comply with the ISO 11737-2 standard can result in severe consequences, including:

  • Product recalls

  • Regulatory action

  • Loss of market share

  • Damage to reputation and brand image

    • Why This Specific Test is Needed and Required

    The ISO 11737-2 testing service is essential for ensuring the sterility and bioburden control of medical devices. The test provides a critical evaluation of sterilization processes, which is crucial for product safety and reliability.

    Business and Technical Reasons for Conducting ISO 11737-2 Testing

    The following are the key reasons why medical device manufacturers require ISO 11737-2 testing:

  • Ensure product safety and reliability

  • Meet regulatory requirements

  • Maintain customer confidence and trust

  • Enhance market positioning and competitiveness

    • Consequences of Not Performing This Test

    Failure to conduct ISO 11737-2 testing can result in the following consequences:

  • Regulatory non-compliance

  • Product recalls

  • Damage to reputation and brand image

  • Loss of market share

    • Industries and Sectors That Require This Testing

    The following industries and sectors require ISO 11737-2 testing:

  • Medical devices

  • Pharmaceutical products

  • Biotechnology products

    • Risk Factors and Safety Implications

    The risk factors associated with non-compliance to the ISO 11737-2 standard are significant, including:

  • Patient harm or death

  • Product contamination

  • Regulatory action

    • Quality Assurance and Quality Control Aspects

    ISO 11737-2 testing is an essential component of quality assurance and quality control processes. The test ensures that sterilization processes meet regulatory requirements and industry standards.

    How This Test Contributes to Product Safety and Reliability

    The ISO 11737-2 testing service provides a critical evaluation of sterilization processes, which contributes to product safety and reliability in the following ways:

  • Ensures product sterility

  • Evaluates bioburden control

  • Verifies compliance with regulatory requirements

    • Competitive Advantages of Having This Testing Performed

    Medical device manufacturers that conduct ISO 11737-2 testing enjoy several competitive advantages, including:

  • Enhanced market positioning and competitiveness

  • Improved customer confidence and trust

  • Increased brand image and reputation

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of performing the ISO 11737-2 testing service is favorable for medical device manufacturers. The benefits include:

  • Regulatory compliance

  • Product safety and reliability

  • Enhanced market positioning and competitiveness

    • Eurolab provides comprehensive ISO 11737-2 testing services to medical device manufacturers, ensuring that their products meet regulatory requirements and industry standards. Our expert team conducts thorough evaluations of sterilization processes, providing detailed reports and recommendations for improvement.

    Benefits of Working with Eurolab

    Our clients benefit from the following advantages when working with us:

  • Expertise in ISO 11737-2 testing

  • Comprehensive evaluation of sterilization processes

  • Detailed reports and recommendations for improvement

  • Regulatory compliance

  • Product safety and reliability

    • In conclusion, the ISO 11737-2 standard is a critical component of the sterility assurance and bioburden control testing process. Medical device manufacturers require this testing to ensure product safety and reliability, meet regulatory requirements, and maintain customer confidence and trust. Eurolab provides comprehensive ISO 11737-2 testing services, ensuring that our clients products meet industry standards and regulatory requirements.

    We recommend the following for medical device manufacturers:

  • Conduct regular ISO 11737-2 testing to ensure product safety and reliability

  • Meet regulatory requirements by complying with ISO 11138 and FDA 21 CFR Part 820

  • Enhance market positioning and competitiveness through compliance with industry standards

  • Improve customer confidence and trust through transparent communication of testing results

    • The future direction for the ISO 11737-2 standard includes ongoing revisions to reflect new technologies, scientific advancements, and regulatory requirements. Eurolab will continue to provide expert services in ISO 11737-2 testing, ensuring that our clients products meet evolving industry standards.

    The following appendices provide additional information on the ISO 11737-2 standard:

  • Appendix A: Glossary of Terms

  • Appendix B: Abbreviations and Acronyms

  • Appendix C: List of Relevant Standards

    • Need help or have a question?
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