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iso-10993-40-evaluation-of-hemocompatibility
Biocompatibility Testing ASTM F1609 Evaluation of Surface ContaminationASTM F1904 Protein Adsorption TestingASTM F1980 Accelerated Aging of Medical DevicesASTM F2027 Cytotoxicity EvaluationASTM F2028 Evaluation of Sterilization ResidualsASTM F2052 Magnetically Induced DisplacementASTM F2080 Durability TestingASTM F2095 Evaluation of Additives in Medical PolymersASTM F2096 Particulate TestingASTM F2100 Medical Mask TestingASTM F2130 Endotoxin TestingASTM F2149 Antimicrobial Activity TestingASTM F2180 Sterilization Validation for HydrogelsASTM F2182 RF Induced Heating TestsASTM F2213 Evaluation of Magnetic Resonance CompatibilityASTM F2255 Acute Systemic ToxicityASTM F2273 Cytokine AnalysisASTM F2392 Implant Wear Debris AnalysisASTM F2458 Biofilm Formation TestingASTM F2459 Adhesion of Medical Device CoatingsASTM F2478 Safety Evaluation of PolymersASTM F2503 MR Safety LabelingASTM F2900 Testing of BiopolymersASTM F2941 Shelf Life TestingASTM F640 Extraction of Medical DevicesASTM F748 Evaluation of Medical Device BiocompatibilityASTM F756 Assessment of Hemolytic PropertiesEN ISO 10993-1 Biological Evaluation – Part 1EN ISO 10993-10 Sensitization TestingEN ISO 10993-11 Systemic ToxicityEN ISO 10993-5 Cytotoxicity TestingIEC 60601-1 Safety Requirements for Medical Electrical EquipmentISO 10993-1 Biological Evaluation of Medical DevicesISO 10993-10 Sensitization TestingISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation and Reference MaterialsISO 10993-13 Identification and Quantification of Degradation ProductsISO 10993-14 Degradation TestingISO 10993-15 Toxicokinetic StudyISO 10993-16 Toxicokinetic Study ProtocolISO 10993-17 Establishing Allowable LimitsISO 10993-18 Chemical Characterization TechniquesISO 10993-19 Biodegradation TestingISO 10993-2 Animal Welfare RequirementsISO 10993-20 Toxicology Data AnalysisISO 10993-21 Evaluation of Metals and AlloysISO 10993-22 Irradiation of Medical DevicesISO 10993-23 Biological Evaluation of ResidualsISO 10993-24 Toxicological Risk AssessmentISO 10993-25 Genotoxicity in Medical DevicesISO 10993-26 Immunotoxicology TestingISO 10993-27 Implant Material CharacterizationISO 10993-28 Evaluation of Metallic ImplantsISO 10993-29 Extraction ConditionsISO 10993-3 Genotoxicity TestingISO 10993-30 Analytical TechniquesISO 10993-31 Mutagenicity TestingISO 10993-32 Toxicity Tests for Medical PolymersISO 10993-33 Biological Evaluation of Degradation ProductsISO 10993-34 Evaluation of Chemical ResiduesISO 10993-35 Assessment of Extractables and LeachablesISO 10993-36 Nonclinical Safety EvaluationISO 10993-37 Evaluation of Cytokine ReleaseISO 10993-38 Endocrine Disruption TestingISO 10993-39 Evaluation of Material ExtractsISO 10993-4 Hemocompatibility TestingISO 10993-41 Toxicological Risk Assessment FrameworkISO 10993-42 Assessment of NanomaterialsISO 10993-5 Cytotoxicity TestingISO 10993-6 Local Effects after ImplantationISO 10993-7 Ethylene Oxide ResidualsISO 10993-9 Chemical CharacterizationISO 11135 Ethylene Oxide SterilizationISO 11137 Radiation SterilizationISO 11607 Packaging for Terminally Sterilized DevicesISO 11607-1 Packaging ValidationISO 11607-2 Packaging MaterialsISO 11607-3 Packaging TestingISO 11737-1 Sterilization ValidationISO 11737-2 Microbial Limit TestsISO 11737-3 Bioburden DeterminationISO 13408 Aseptic ProcessingISO 13408-1 Cleanroom TestingISO 13408-2 Aseptic Processing ValidationISO 13485 Quality Management Systems for Medical DevicesISO 13485 Risk Management IntegrationISO 13485-1 Quality System RequirementsISO 14117 Pulse Oximeter PerformanceISO 14155 Clinical Investigation StandardsISO 14155-1 Clinical Trial DesignISO 14155-2 Clinical Trial ConductISO 14160 Biocompatibility for Transfusion EquipmentISO 14161 Sterilization by Ethylene OxideISO 14161 Validation of Sterilization ProcessesISO 14630 Non-active Surgical ImplantsISO 14644 Cleanroom StandardsISO 14708 Active Implantable Medical DevicesISO 14708-3 Active Implantable Device TestingISO 14708-4 Implantable Device SafetyISO 14969 Quality Management for Sterile DevicesISO 14971 Risk Management DocumentationISO 14971 Risk Management for Medical DevicesISO 14971-2 Risk Management ReportingISO 15223 Medical Device SymbolsISO 17025 Testing Laboratory AccreditationISO 18113 Medical Device LabelingISO 18562 Biocompatibility of Breathing Gas PathwaysISO 22442 Medical Device Material TestingISO 25539 Cardiovascular ImplantsISO 25539-2 Coronary StentsISO 7405 Evaluation of Biocompatibility for DentistryISO 80369 Small-Bore ConnectorsUSP <87> Biological Reactivity TestsUSP <88> Tests for Plastic Materials

Comprehensive Guide to ISO 10993-40 Evaluation of Hemocompatibility Laboratory Testing Service

ISO 10993-40 is a standard that evaluates the hemocompatibility of medical devices, which are intended for contact with blood or bodily fluids. This standard is part of the larger ISO 10993 series, which provides guidelines for evaluating the biocompatibility of medical devices.

International and National Standards

The international standards that govern ISO 10993-40 evaluation of hemocompatibility testing include:

  • ISO 10993-1:2018 (Biological evaluation of medical devices Part 1: Evaluation and testing)

  • ISO 10993-4:2017 (Biological evaluation of medical devices Part 4: Selection of tests for interaction with blood)

  • ISO 10993-10:2015 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization)

    • The national standards that apply to this specific laboratory test include:

  • ASTM F748-08 (Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices)

  • EN ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation and testing)

  • TSE ISO 10993-10:2014 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization)

    • Standard Development Organizations

    The standard development organizations involved in the creation of these standards include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Why This Test is Needed

    This test is necessary to ensure that medical devices do not cause adverse reactions or toxicity when in contact with blood or bodily fluids. The consequences of not performing this test can include:

  • Patient safety and health risks

  • Device recall or withdrawal from the market

  • Regulatory non-compliance and fines

    • The standard requirements for ISO 10993-40 evaluation of hemocompatibility testing include:

  • Selection of relevant tests based on device type and intended use

  • Performance of in vitro and/or in vivo tests as required

  • Evaluation of test results using statistical analysis and risk assessment

  • Documentation of test procedures, results, and conclusions

    • The business and technical reasons for conducting ISO 10993-40 evaluation of hemocompatibility testing include:

  • Ensuring patient safety and device efficacy

  • Reducing regulatory risks and compliance costs

  • Improving device performance and reliability

  • Enhancing brand reputation and customer trust

    • The test conditions and methodology for ISO 10993-40 evaluation of hemocompatibility testing include:

  • Selection of relevant blood samples and testing parameters

  • Performance of in vitro tests, such as agglutination, coagulation, and platelet activation assays

  • Evaluation of test results using statistical analysis and risk assessment

  • Documentation of test procedures, results, and conclusions

    • The test reporting and documentation for ISO 10993-40 evaluation of hemocompatibility testing include:

  • Preparation of a comprehensive test report, including test methods, results, and conclusions

  • Evaluation of test results using statistical analysis and risk assessment

  • Documentation of test procedures, results, and conclusions in accordance with regulatory requirements

    • The benefits and advantages of performing ISO 10993-40 evaluation of hemocompatibility testing include:

  • Ensuring patient safety and device efficacy

  • Reducing regulatory risks and compliance costs

  • Improving device performance and reliability

  • Enhancing brand reputation and customer trust

  • Supporting innovation and research development

  • Facilitating international market access and trade

    • Eurolabs expertise and experience in hemocompatibility testing include:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

  • Customer service and support capabilities

    • Additional Requirements

    The additional requirements for this comprehensive guide include:

  • Use of professional and technical language appropriate for laboratory testing

  • Inclusion of relevant technical specifications and parameters

  • Provision of industry-specific examples and case studies

  • Use of bullet points and numbered lists for better readability

    • Formatting Requirements

    The formatting requirements for this comprehensive guide include:

  • Use of HTML formatting for better structure

  • Inclusion of

    ,

    ,

    tags for section headers

  • Use of
      and
    • tags for bullet points

    • Use of tags for emphasis

      • Target Audience

      The target audience for this comprehensive guide includes:

    • Quality managers and engineers

    • Regulatory affairs professionals

    • Medical device manufacturers and suppliers

    • Research and development teams

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

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