EUROLAB
iso-10993-18-bioburden-interaction-with-extractables-and-leachables
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 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 80369-1 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

Comprehensive Guide to ISO 10993-18 Bioburden Interaction with Extractables and Leachables Testing Services by Eurolab

ISO 10993-18 is a standard that governs the testing of bioburden interaction with extractables and leachables in medical devices. This standard is part of the larger ISO 10993 series, which covers the biological evaluation of medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-18 testing is governed by various international and national standards. These include:

  • ISO 10993: Biological evaluation of medical devices

  • ASTM F748: Standard practice for selection of materials and substrates that are compatible with implantable devices

  • EN 556: Medical devices - Sterilization requirements for the formulation, filling, packaging, storage, and handling of presterilized single-use medical devices in sterile packs

  • TSE 1171: Biological evaluation of medical devices

    • International and National Standards

    The following international and national standards apply to ISO 10993-18 testing:

  • ISO 10993-1: Evaluation and testing within a risk management process

  • ISO 10993-5: Tests for in vitro cytotoxicity

  • ASTM F748: Standard practice for selection of materials and substrates that are compatible with implantable devices

    • Standard Development Organizations

    The standard development organizations responsible for developing and maintaining the standards related to ISO 10993-18 testing include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, science, and regulation. The following standards have undergone revisions or updates related to ISO 10993-18 testing:

  • ISO 10993-1:2009 Amd 1:2014

  • ASTM F748:2016

    • Specific Standard Numbers and Scope

    The following standard numbers and scopes apply to ISO 10993-18 testing:

  • ISO 10993-1: Evaluation and testing within a risk management process (scope: evaluation of biological risk)

  • ISO 10993-5: Tests for in vitro cytotoxicity (scope: tests for cellular toxicity)

    • Standard Compliance Requirements

    Compliance with ISO 10993-18 is required for medical devices that come into contact with the body or are used in a clinical setting. The following industries and sectors require compliance:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • Why this Specific Test is Needed and Required

    The bioburden interaction with extractables and leachables test is necessary to assess the biological safety of medical devices. This test helps ensure that medical devices do not pose a risk to patients or users.

    Business and Technical Reasons for Conducting ISO 10993-18 Testing

    Conducting ISO 10993-18 testing provides several business and technical reasons:

  • Ensures compliance with regulatory requirements

  • Reduces the risk of product liability

  • Improves patient safety and satisfaction

  • Enhances product quality and performance

    • Consequences of Not Performing this Test

    Failure to conduct ISO 10993-18 testing can have severe consequences, including:

  • Product recalls or withdrawals

  • Regulatory fines or penalties

  • Damage to brand reputation and customer trust

    • Industries and Sectors that Require this Testing

    The following industries and sectors require ISO 10993-18 testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • Risk Factors and Safety Implications

    ISO 10993-18 testing helps mitigate the risk factors associated with bioburden interaction with extractables and leachables, including:

  • Bacterial contamination

  • Viral transmission

  • Chemical toxicity

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 10993-18 testing involves quality assurance and control aspects, including:

  • Calibration of equipment

  • Validation of methods

  • Training of personnel

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

    The bioburden interaction with extractables and leachables test involves the following steps:

    1. Sample preparation: The medical device sample is prepared for testing by cleaning, disinfecting, or sterilizing it.

    2. Testing equipment and instruments: Specialized equipment and instruments are used to conduct the test, including a sterilization chamber, a sampling system, and analytical instruments such as chromatographs and spectrophotometers.

    3. Testing environment requirements: The testing environment requires specific conditions, including temperature, humidity, and pressure control.

    4. Sample preparation procedures: The sample is prepared according to established protocols, including cleaning, disinfecting, or sterilizing it.

    Detailed Explanation of the Testing Process

    The bioburden interaction with extractables and leachables test involves the following testing process:

    1. Sampling: A representative sample of the medical device is collected for analysis.

    2. Extraction: The sample is extracted using a solvent to release any chemicals that may be present.

    3. Separation: The extracts are separated from other components using chromatography or spectrophotometry.

    4. Detection and quantification: The presence and concentration of extractables and leachables are detected and quantified using analytical instruments.

    Detailed Explanation of the Analytical Instruments Used

    The following analytical instruments are used to conduct the bioburden interaction with extractables and leachables test:

  • Chromatographs (e.g., HPLC, GC-MS)

  • Spectrophotometers

  • Mass spectrometers

    • Interpretation of Results

    The results of the bioburden interaction with extractables and leachables test are interpreted according to established protocols. The presence and concentration of extractables and leachables are used to assess the biological safety of the medical device.

    Please let me continue with the rest of the sections as requested.

    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