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iso-10993-4-hemocompatibility-testing
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 10993-40 Evaluation of HemocompatibilityISO 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 10993-4 Hemocompatibility Testing Laboratory Testing Service Provided by Eurolab

ISO 10993-4 is an international standard that governs the hemocompatibility testing of medical devices, including their biocompatibility and biological safety. The standard specifies the requirements for in vitro tests to evaluate the potential adverse effects of medical devices on the blood and its components.

Legal and Regulatory Framework

The ISO 10993 series is a set of standards developed by the International Organization for Standardization (ISO) to ensure the safety, effectiveness, and quality of medical devices. The European Unions Medical Devices Regulation (MDR) and the US Food and Drug Administrations (FDA) regulations require manufacturers to comply with these standards.

International and National Standards

The ISO 10993 series is harmonized with other international standards, including:

  • ASTM F748-17 (Standard Practice for Selecting, Testing, and Specifying Biomedical Materials and Devices)

  • EN ISO 10993-1:2018 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process)

  • TSE 13414:2019 (Medical devices Biological safety assessment)

    • Standard Development Organizations

    The ISO 10993 series is developed by Technical Committee ISO/TC 194, Biomedical materials and devices. This committee brings together experts from around the world to develop standards that ensure the safety and effectiveness of medical devices.

    Evolution and Updates

    Standards are regularly reviewed and updated to reflect new scientific knowledge and technological advancements. The latest versions of the ISO 10993 series were published in 2018, with updates expected in the coming years.

    Standard Numbers and Scope

    The ISO 10993-4 standard is one part of a larger series that covers various aspects of medical device safety:

  • ISO 10993-1: General requirements

  • ISO 10993-2: Biological evaluation under cyclic loading

  • ISO 10993-3: Tests for genetic toxicity, in vitro mammalian chromosome aberration test (in vitro)

  • ISO 10993-4: Selection of tests for interactions with blood

  • ISO 10993-5: Tests for cytotoxicity in vitro

    • Compliance Requirements

    Medical device manufacturers must comply with the relevant standards and regulations when developing products. Non-compliance can result in product recalls, fines, or even legal action.

    In addition to the ISO 10993 series, medical device manufacturers must also comply with industry-specific standards and regulations:

  • European Union: MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR)

  • United States: FDAs Quality System Regulation (QSR) and Good Laboratory Practice (GLP)

  • Japan: Pharmaceutical and Medical Device Agency (PMDA)

    • ISO 10993-4 Hemocompatibility Testing is a critical step in ensuring the safety of medical devices that come into contact with blood. The standard requires manufacturers to select and validate in vitro tests to evaluate their products potential adverse effects on blood components.

    Why This Test Is Needed

    The ISO 10993-4 testing service is required for medical devices that:

  • Come into contact with blood or its components

  • Are intended for implantation or use within the body

  • Have potential toxicity or biocompatibility issues

    • Business and Technical Reasons

    Conducting ISO 10993-4 Hemocompatibility Testing provides manufacturers with several benefits, including:

  • Reduced risk of product liability

  • Enhanced reputation and credibility in the industry

  • Improved regulatory compliance and reduced costs associated with non-compliance

  • Better understanding of product performance and potential issues

    • Consequences of Not Performing This Test

    Failure to perform ISO 10993-4 Hemocompatibility Testing can result in:

  • Product recalls or withdrawals

  • Fines, penalties, or legal action

  • Damage to reputation and loss of customer trust

  • Inability to market products in certain countries or regions

    • Industries and Sectors

    The following industries require ISO 10993-4 Hemocompatibility Testing:

  • Medical device manufacturers (e.g., implantable devices, surgical instruments)

  • Pharmaceutical companies (e.g., biologics, injectables)

  • Biotechnology firms (e.g., cell therapy products, gene therapies)

    • Risk Factors and Safety Implications

    Medical devices that come into contact with blood can pose significant risks to patients, including:

  • Infection

  • Allergic reactions

  • Hemolysis or hemoglobinuria

  • Clotting disorders

    • Quality Assurance and Quality Control Aspects

    ISO 10993-4 Hemocompatibility Testing is an essential component of a manufacturers quality management system. It helps ensure that products meet regulatory requirements, industry standards, and customer expectations.

    How This Test Contributes to Product Safety and Reliability

    The ISO 10993-4 testing service contributes to product safety and reliability by:

  • Evaluating the potential adverse effects of medical devices on blood components

  • Identifying and mitigating potential risks associated with product use

  • Ensuring compliance with regulatory requirements and industry standards

    • In addition to ISO 10993-4 Hemocompatibility Testing, manufacturers must also consider other aspects of product safety and reliability, including:

  • Clinical trials and post-market surveillance

  • User manual development and training programs

  • Device labeling and instructions for use

    • Selection of Tests

    The ISO 10993-4 standard specifies the selection of tests to evaluate the potential adverse effects of medical devices on blood components. The following factors should be considered when selecting tests:

  • Product characteristics and design

  • Intended use and application

  • Material composition and properties

  • Biological interactions and mechanisms

    • In Vitro Tests

    The ISO 10993-4 standard includes several in vitro tests to evaluate the potential adverse effects of medical devices on blood components, including:

  • Hemolysis tests (e.g., ISO 10993-12:2018)

  • Cytotoxicity tests (e.g., ISO 10993-5:2009)

  • Protein adsorption tests (e.g., ISO 10993-6:1994)

    • Testing Methods and Protocols

    Manufacturers must select and validate testing methods and protocols that meet the requirements of the ISO 10993-4 standard. The following aspects should be considered:

  • Test sensitivity and specificity

  • Test robustness and reproducibility

  • Test conditions and parameters

    • Validation and Verification

    ISO 10993-4 Hemocompatibility Testing requires manufacturers to validate and verify their testing methods and protocols, including:

  • Method validation (e.g., ISO 10993-1:2018)

  • Method verification (e.g., ISO 10993-2:2019)

    • In conclusion, the ISO 10993-4 Hemocompatibility Testing service is an essential component of a manufacturers quality management system. It helps ensure that products meet regulatory requirements, industry standards, and customer expectations.

    The following key takeaways should be considered:

  • The ISO 10993 series is a set of international standards for biological evaluation of medical devices.

  • ISO 10993-4 Hemocompatibility Testing evaluates the potential adverse effects of medical devices on blood components.

  • Manufacturers must select and validate in vitro tests to evaluate their products potential adverse effects on blood components.

  • Consequences of not performing this test include product recalls or withdrawals, fines, penalties, or legal action.

    • Eurolabs ISO 10993-4 Hemocompatibility Testing Service

    Eurolab is an internationally accredited testing laboratory with expertise in hemocompatibility testing. Our state-of-the-art facilities and experienced staff ensure that we provide high-quality results on time and within budget.

    We offer the following services:

  • In vitro tests for hemolysis, cytotoxicity, and protein adsorption

  • Method validation and verification

  • Testing method selection and development

    • Contact us today to learn more about our ISO 10993-4 Hemocompatibility Testing service.

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

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