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aatcc-tm100-test-for-antimicrobial-activity-of-textiles
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsANSI/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 80369-1 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

AATCC TM100 Test for Antimicrobial Activity of Textiles Laboratory Testing Service Provided by Eurolab

The AATCC TM100 Test for Antimicrobial Activity of Textiles is a widely recognized and adopted laboratory testing service that evaluates the effectiveness of antimicrobial treatments on various textile materials. This test method is governed by several international and national standards, including:

  • ISO 20743:2013 (Textiles Determination of antibacterial activity)

  • ASTM E2180-15 (Standard Test Method for Evaluating Antibacterial Activity of Materials)

  • EN 14126:2004 (Medical face masks. Requirements for materials, design, measurement, testing and labelling)

    • The legal and regulatory framework surrounding this testing service is governed by various national laws and regulations, such as the European Unions Medical Device Regulation (MDR), which requires antimicrobial-treated medical devices to meet specific performance standards.

    Standard Development Organizations

    The standard development process involves several organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations collaborate with industry experts, regulatory bodies, and other stakeholders to develop and update standards.

    Standard Evolution and Updates

    Standards are subject to revision and updates as new technologies emerge or existing requirements change. For example, the ISO 20743 standard has undergone several revisions since its initial publication in 2006.

    Specific Standard Numbers and Scope

    Some key standard numbers related to antimicrobial activity testing are:

  • ISO 20743:2013 - Textiles Determination of antibacterial activity

  • ASTM E2180-15 - Standard Test Method for Evaluating Antibacterial Activity of Materials

  • EN 14126:2004 - Medical face masks. Requirements for materials, design, measurement, testing and labelling

    • These standards cover various aspects of antimicrobial activity testing, including:

  • Bacterial inhibition zones

  • Colony forming unit (CFU) counting

  • pH and temperature effects on antimicrobial efficacy

    • Standard Compliance Requirements

    Different industries have varying compliance requirements for antimicrobial-treated textiles. For example:

  • Medical devices: Must comply with EU MDR regulations

  • Apparel and home textiles: May require compliance with ISO 20743 or ASTM E2180 standards

    • Why This Test is Needed and Required

    The AATCC TM100 test is essential for evaluating the effectiveness of antimicrobial treatments on various textile materials. This test method provides accurate and reliable results, enabling manufacturers to:

  • Ensure product safety and performance

  • Meet regulatory compliance requirements

  • Gain market access and customer confidence

    • Consequences of Not Performing This Test

    Failure to conduct this test can result in:

  • Product recalls due to inadequate antimicrobial efficacy

  • Regulatory non-compliance and fines

  • Loss of customer trust and reputation damage

    • Industries and Sectors that Require This Testing

    The following industries require antimicrobial activity testing for textiles:

  • Medical devices (e.g., surgical masks, hospital gowns)

  • Apparel and home textiles (e.g., clothing, bedding, upholstery)

  • Personal protective equipment (PPE) manufacturers

  • Healthcare facilities

    • Risk Factors and Safety Implications

    Antimicrobial-treated textiles must be evaluated to ensure they meet required safety standards. Failure to do so can result in:

  • Inadequate protection against microorganisms

  • Potential health risks for consumers or users

    • Quality Assurance and Quality Control Aspects

    The AATCC TM100 test is subject to quality assurance and quality control measures, including:

  • Calibration and validation of testing equipment

  • Training and certification of personnel

  • Data recording and analysis procedures

    • Competitive Advantages and Market Positioning

    By performing the AATCC TM100 test, manufacturers can:

  • Gain market access and competitive advantage

  • Differentiate their products from competitors

  • Build customer trust and confidence in product performance

    • Cost-Benefit Analysis of Performing This Test

    The benefits of performing the AATCC TM100 test far outweigh the costs. Manufacturers can expect:

  • Cost savings due to reduced recall rates and regulatory non-compliance

  • Increased market share and revenue growth

  • Improved brand reputation and customer loyalty

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

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