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iso-10993-38-endocrine-disruption-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 10993-39 Evaluation of Material ExtractsISO 10993-4 Hemocompatibility TestingISO 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

ISO 10993-38 Endocrine Disruption Testing: Laboratory Testing Services by Eurolab

Overview of Relevant Standards

The ISO 10993-38 standard, also known as the Biological evaluation of medical devices - Part 38: Tests for endocrine disruption, is a widely recognized and adopted standard for evaluating the potential endocrine-disrupting effects of medical devices. This standard is part of the larger ISO 10993 series, which covers the biological evaluation of medical devices.

International Standards

  • ISO 10993-1: General requirements for testing

  • ISO 10993-2: Animal welfare requirements

  • ISO 10993-38: Tests for endocrine disruption

    • Standard Development Organizations and Their Role

    The International Organization for Standardization (ISO) is a non-profit organization that develops and publishes international standards. The ISO/TC 194 committee, also known as the Biological and clinical evaluation of medical devices technical committee, is responsible for developing and maintaining the ISO 10993 series.

    Legal and Regulatory Framework

    The regulatory framework surrounding endocrine disruption testing varies by country. However, many countries, including the United States (US FDA), European Union (EU), and Japan, have regulations that require medical device manufacturers to assess the potential endocrine-disrupting effects of their products.

    Examples of Regulations:

  • US FDA: 21 CFR Part 606

  • EU MDR: Annex I

  • Japanese MHLW: Ordinance No. 2

    • Standard Compliance Requirements for Different Industries

    Different industries have varying levels of standard compliance requirements. Medical device manufacturers, in particular, must adhere to the ISO 10993-38 standard to ensure their products meet regulatory requirements.

    Medical Device Industry:

  • Manufacturers must comply with the ISO 10993-38 standard

  • Testing results must be documented and reported according to the standard

    • Evolving Standards and Requirements

    Standards evolve over time as new research emerges, and regulatory requirements change. The ISO 10993 series is no exception.

    Changes in ISO 10993-38:

  • Update of test methods for assessing endocrine disruption

  • New requirements for reporting and documentation

    • Industry-Specific Examples and Case Studies

    The ISO 10993-38 standard applies to various medical device categories, including:

  • Implantable devices: Cardiac pacemakers, hip replacements

  • In vitro diagnostic devices: Diagnostic kits, laboratory instruments

    • Why This Test is Needed and Required

    Endocrine disruption testing is essential for ensuring the safety and efficacy of medical devices.

    Business and Technical Reasons:

  • Regulatory compliance

  • Safety and efficacy assurance

  • Quality control and assurance

    • Consequences of Not Performing this Test:

  • Regulatory non-compliance

  • Product recall or withdrawal

  • Loss of customer trust and confidence

    • Industries and Sectors that Require this Testing:

    The ISO 10993-38 standard applies to various industries, including medical devices, pharmaceuticals, and cosmetics.

    Medical Device Industry:

  • Manufacturers must comply with the ISO 10993-38 standard

  • Testing results must be documented and reported according to the standard

    • Risk Factors and Safety Implications:

    Endocrine disruption testing helps identify potential risks associated with medical device use.

    Examples of Endocrine Disruption Risks:

  • Thyroid problems

  • Reproductive issues

  • Neurological effects

    • Quality Assurance and Compliance Benefits:

    Endocrine disruption testing ensures compliance with regulatory requirements and industry standards.

    Benefits:

  • Regulatory compliance

  • Improved product safety and efficacy

  • Enhanced customer trust and confidence

    • Competitive Advantages and Market Positioning:

    Companies that adhere to the ISO 10993-38 standard demonstrate their commitment to quality and safety.

    Cost Savings and Efficiency Improvements:

    Endocrine disruption testing helps identify potential risks, reducing costs associated with product recall or withdrawal.

    The test conditions and methodology for endocrine disruption testing involve a series of steps:

    1. Sample Preparation: Prepare the medical device samples according to the standard.

    2. Testing Equipment: Use standardized testing equipment and instruments, such as spectrophotometers or chromatography systems.

    3. Testing Environment: Conduct testing in a controlled environment with precise temperature, humidity, and pressure conditions.

    Step-by-Step Explanation of Testing:

    1. Prepare the medical device samples according to the standard.

    2. Select and calibrate the testing equipment and instruments.

    3. Conduct testing in a controlled environment.

    4. Analyze the results using standardized methods and software.

    The test report must be comprehensive, clear, and concise.

    Test Report Requirements:

  • Document the test methodology

  • Provide detailed results and analysis

  • Include recommendations for future testing or improvements

    • Industry-Specific Examples and Case Studies:

    Endocrine disruption testing applies to various medical device categories:

  • Implantable devices: Cardiac pacemakers, hip replacements

  • In vitro diagnostic devices: Diagnostic kits, laboratory instruments

    • Why Choose Eurolab for Your Endocrine Disruption Testing Needs?

    Eurolab is a leading provider of endocrine disruption testing services. Our team of experts ensures compliance with the ISO 10993-38 standard.

    Benefits of Choosing Eurolab:

  • Regulatory compliance

  • Improved product safety and efficacy

  • Enhanced customer trust and confidence

    • Conclusion:

    The ISO 10993-38 standard is essential for ensuring the safety and efficacy of medical devices. Endocrine disruption testing helps identify potential risks associated with medical device use. Companies that adhere to this standard demonstrate their commitment to quality and safety.

    Get in Touch:

    Contact us today to learn more about our endocrine disruption testing services.

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