EUROLAB
iso-80369-1-endotoxin-limits-for-small-bore-connectors
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 11737-2 Sterility Assurance and Bioburden ControlISO 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 80369-7 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 80369-1 Endotoxin Limits for Small-Bore Connectors Laboratory Testing Service: A Comprehensive Guide

The ISO 80369-1 standard is a globally recognized standard that outlines the requirements for endotoxin limits in small-bore connectors used in medical devices. This standard is developed and maintained by the International Organization for Standardization (ISO) through its technical committee, TC 194, Medical devices.

Legal and Regulatory Framework

The ISO 80369-1 standard is a normative document that provides specific requirements for manufacturers of small-bore connectors to ensure the safety and efficacy of their products. Compliance with this standard is mandatory in many countries, including the European Union (EU), the United States (US), Japan, and China.

International and National Standards

The ISO 80369-1 standard is based on a series of national standards, including:

  • EN ISO 80369-1:2010 (European Standard)

  • ASTM F739-14 (American Standard)

  • JIS Z 3018:2006 (Japanese Standard)

    • These national standards are often referred to as adopted or aligned with the ISO standard.

    Standard Development Organizations

    The development and maintenance of the ISO 80369-1 standard involve various stakeholders, including:

  • ISO Technical Committee 194 (TC 194)

  • European Committee for Standardization (CEN)

  • American Society for Testing and Materials (ASTM)

    • These organizations work together to ensure that the standard remains relevant, up-to-date, and aligned with global regulatory requirements.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, science, or regulations. The ISO 80369-1 standard has undergone several revisions since its initial publication in 2006. Recent updates include:

  • ISO 80369-1:2018

  • EN ISO 80369-1:2020

    • Standard Numbers and Scope

    The relevant standard numbers for this testing service are:

  • ISO 80369-1:2018 (Endotoxin limits for small-bore connectors)

  • EN ISO 80369-1:2020 (Endotoxin limits for small-bore connectors, European Standard)

    • These standards specify the requirements for endotoxin limits in small-bore connectors used in medical devices.

    Standard Compliance Requirements

    Manufacturers of small-bore connectors must comply with the relevant national or international standard, depending on their country of operation. Compliance with ISO 80369-1 ensures that products meet minimum safety and efficacy requirements.

    Industry-Specific Examples

    The following industries require compliance with ISO 80369-1:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Government agencies (e.g., FDA, EMA)

    • These organizations must ensure that their small-bore connectors comply with the relevant standard to avoid regulatory issues or product recalls.

    The ISO 80369-1 standard was developed in response to concerns about the safety of small-bore connectors used in medical devices. These concerns were fueled by reports of contamination, adverse reactions, and product failures.

    Business and Technical Reasons for Conducting ISO 80369-1 Testing

    Manufacturers must conduct ISO 80369-1 testing to ensure compliance with regulatory requirements, minimize product liability risks, and maintain customer trust. This testing service also helps manufacturers:

  • Identify potential contaminants or defects in small-bore connectors

  • Evaluate the effectiveness of their manufacturing processes

  • Meet international standards for safety and efficacy

    • Consequences of Not Performing ISO 80369-1 Testing

    Failure to conduct ISO 80369-1 testing can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of customer trust and market share

  • Increased liability risks and financial costs

    • Manufacturers must prioritize this testing service to avoid these consequences.

    Industries and Sectors Requiring ISO 80369-1 Testing

    The following industries require ISO 80369-1 testing:

  • Medical device manufacturers (e.g., ventilators, infusion pumps)

  • Pharmaceutical companies

  • Biotechnology firms

  • Government agencies (e.g., FDA, EMA)

    • These organizations must ensure that their small-bore connectors comply with the relevant standard to avoid regulatory issues or product recalls.

    Risk Factors and Safety Implications

    ISO 80369-1 testing helps manufacturers identify potential risks associated with small-bore connectors, including:

  • Contamination

  • Defects

  • Adverse reactions

  • Product failures

    • By conducting this testing service, manufacturers can minimize these risks and ensure the safety of their products.

    Quality Assurance and Quality Control Aspects

    ISO 80369-1 testing is an essential aspect of quality assurance (QA) and quality control (QC). This testing service helps manufacturers:

  • Evaluate the effectiveness of their manufacturing processes

  • Identify potential contaminants or defects in small-bore connectors

  • Meet international standards for safety and efficacy

    • By prioritizing QA and QC, manufacturers can ensure that their products meet minimum safety and efficacy requirements.

    Standard-Related Information Resources

    For more information on the ISO 80369-1 standard, please consult the following resources:

  • ISO website: www.iso.org(http://www.iso.org)

  • EN website: www.en-standard.eu(http://www.en-standard.eu)

  • ASTM website: www.astm.org(http://www.astm.org)

    • ISO 80369-1 Testing Services

    Our laboratory offers ISO 80369-1 testing services to ensure that your small-bore connectors comply with the relevant standard. Our expert technicians and state-of-the-art equipment will help you:

  • Evaluate the effectiveness of your manufacturing processes

  • Identify potential contaminants or defects in small-bore connectors

  • Meet international standards for safety and efficacy

    • Contact us today to learn more about our ISO 80369-1 testing services.

    Conclusion

    The ISO 80369-1 standard is a critical document that outlines the requirements for endotoxin limits in small-bore connectors used in medical devices. Compliance with this standard is mandatory in many countries, including the EU, US, Japan, and China. Manufacturers must conduct ISO 80369-1 testing to ensure compliance with regulatory requirements, minimize product liability risks, and maintain customer trust.

    References

  • ISO 80369-1:2018 (Endotoxin limits for small-bore connectors)

  • EN ISO 80369-1:2020 (Endotoxin limits for small-bore connectors, European Standard)

  • ASTM F739-14 (American Standard)

    • 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