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iso-10993-5-in-vitro-cytotoxicity
Chemical Resistance and Material Compatibility Testing ASTM D130 Copper Corrosion TestingASTM D130 Corrosion Testing of MetalsASTM D2240 Hardness Testing of Polymer MaterialsASTM D2240 Hardness Testing Post Chemical ExposureASTM D256 Impact Resistance After Chemical ExposureASTM D257 Electrical Resistivity Post Chemical ExposureASTM D2765 Thermal Analysis After Chemical ExposureASTM D3359 Adhesion of Coatings Post Chemical ExposureASTM D3359 Adhesion Testing After Chemical ExposureASTM D3762 Abrasion Resistance Post Chemical ExposureASTM D3985 Oxygen Transmission Rate After Chemical ExposureASTM D4216 Chemical Resistance of PolypropyleneASTM D471 Swelling Resistance in LiquidsASTM D4727 Resistance of Rubber to ChemicalsASTM D522 Flexibility Post Chemical ExposureASTM D543 Chemical Resistance of PlasticsASTM D543 Resistance of Plastics to Chemical ReagentsASTM D543-14 Chemical Resistance of Plastics and ElastomersASTM D570 Water Absorption of PlasticsASTM D570 Water Absorption of Polymer SamplesASTM D638 Tensile Properties After Chemical TreatmentASTM D638 Tensile Testing of Chemical-Exposed SamplesASTM D638 Tensile Testing Post Chemical ExposureASTM D648 Heat Deflection Temperature After Chemical ExposureASTM D7338 Chemical Resistance of PolyethyleneASTM D746 Low Temperature Impact Post Chemical ExposureASTM D7569 Resistance to Chemical ExposureASTM D792 Density of Plastics After Chemical ExposureASTM D882 Tensile Properties of Thin Plastic SheetingASTM E96 Water Vapor Transmission Post Chemical ExposureASTM F1515 Chemical Resistance of Medical PlasticsASTM F1522 Resistance to Chemicals in Medical DevicesASTM F1874 Chemical Resistance of ElastomersASTM F2026 Chemical Resistance of Polymeric MaterialsASTM F2028 Chemical Compatibility of Surgical InstrumentsASTM F2033 Chemical Resistance of Medical PolymersASTM F2299 Resistance to Bacterial PenetrationASTM F2397 Chemical Resistance of ElastomersASTM F739 Chemical Permeation TestingASTM F748 Resistance of Polymers to ChemicalsASTM F903 Liquid Penetration ResistanceASTM F904 Chemical Resistance of Polymers in Medical UseISO 10993-1 Biological Evaluation ProcessISO 10993-10 Biological Evaluation of MaterialsISO 10993-10 Irritation Testing Post Chemical ExposureISO 10993-11 Cytotoxicity Testing Post Chemical ExposureISO 10993-12 Chemical Resistance Sample PreparationISO 10993-13 Extraction Methods for Medical DevicesISO 10993-14 Degradation Products in Medical MaterialsISO 10993-15 Identification of Degradation ProductsISO 10993-16 Toxicokinetics of MaterialsISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical Characterization of Medical DevicesISO 10993-19 Chemical Characterization for Medical DevicesISO 10993-2 Animal Welfare Requirements in TestingISO 10993-20 Sensitization TestingISO 10993-21 Evaluation of Degradation ProductsISO 10993-22 Evaluation of Material InteractionISO 10993-23 Assessment of ToxicityISO 10993-24 Evaluation of Extractables and LeachablesISO 10993-25 Material Compatibility ValidationISO 10993-26 Chronic Toxicity TestingISO 10993-27 Immunotoxicology TestingISO 10993-28 Mutagenicity TestingISO 10993-29 Chemical Residue LimitsISO 10993-3 Genotoxicity Testing of Medical MaterialsISO 10993-30 Toxicological Risk AssessmentISO 10993-4 Blood Compatibility TestingISO 10993-4 Hemocompatibility TestingISO 10993-6 Local Effects after Chemical ExposureISO 10993-7 Ethylene Oxide Residue LimitsISO 10993-8 Material Compatibility with BloodISO 10993-9 Selection of Tests for Medical MaterialsISO 11135 Material Compatibility in EO SterilizationISO 11135-1 EO Sterilization Material CompatibilityISO 11135-2 EO Sterilization Effects on MaterialsISO 11137 Chemical Resistance of Sterilized DevicesISO 11607 Material Compatibility with SterilizationISO 13485 Material Compatibility RequirementsISO 14644-1 Cleanroom Material CompatibilityISO 14644-3 Cleanroom Material CompatibilityISO 22442 Compatibility of Implants with Biological SystemsISO 22442-2 Biocompatibility TestingISO 22442-3 Evaluation of Material Safety

Comprehensive Guide to ISO 10993-5 In Vitro Cytotoxicity Laboratory Testing Service Provided by Eurolab

ISO 10993-5 is a standard that outlines the requirements for in vitro cytotoxicity testing of medical devices. This standard is part of the larger ISO 10993 series, which provides guidelines for biocompatibility testing of medical devices.

The ISO 10993-5 standard requires manufacturers to test their medical devices for potential cytotoxic effects on cells and tissues. The standard specifies a range of testing methods, including ELISA (Enzyme-Linked Immunosorbent Assay) and MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assays.

The legal and regulatory framework surrounding ISO 10993-5 testing is governed by various international and national standards. These include:

  • ISO 10993-5:2019, In vitro cytotoxicity tests for medical devices Part 5: Test for cytotoxicity in vitro

  • ASTM F739-08 (2013), Standard Test Method for Cytotoxicity of Materials Associated with Medical Devices

  • EN ISO 10993-5:2019, Biological evaluation of medical devices Part 5: Tests for cytotoxicity in vitro

  • TSE LISO 10993-5:2014, Norma de evaluación biológica de dispositivos médicos Parte 5: Pruebas para la citotoxicidad in vitro

    • Standard development organizations play a crucial role in the development and maintenance of standards. These organizations include:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • ENI (European Committee for Electrotechnical Standardization)

  • TSE (Turkish Standards Institution)

    • Standards evolve over time as new technologies and research findings become available. This process involves the revision of existing standards or the development of new ones.

    ISO 10993-5 testing is essential for ensuring the biocompatibility and safety of medical devices. The business and technical reasons for conducting this test include:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements and compliance standards

  • Protecting patients from potential harm caused by cytotoxic materials

  • Preventing costly recalls and litigation

  • Enhancing brand reputation and market credibility

    • Consequences of not performing ISO 10993-5 testing can be severe, including:

  • Regulatory non-compliance and fines

  • Product recalls and withdrawals

  • Damage to brand reputation and customer trust

  • Increased liability and potential lawsuits

    • This test is required in various industries, including:

  • Medical device manufacturing

  • Pharmaceutical and biotechnology

  • Cosmetics and personal care

  • Food and beverage

    • Risk factors associated with cytotoxic materials include:

  • Allergic reactions and sensitization

  • Tissue damage and inflammation

  • Cancerous cell growth and tumor formation

  • Neurotoxicity and central nervous system damage

    • Quality assurance and quality control measures are essential for ensuring the accuracy and reliability of ISO 10993-5 testing results.

    The ISO 10993-5 test involves a series of steps, including:

    1. Sample preparation: The medical device is cleaned, sterilized, and prepared for testing.

    2. Cell culture: Cells are grown in culture media and exposed to the medical device sample.

    3. Testing: The cells are subjected to various cytotoxicity tests, including ELISA and MTT assays.

    4. Data analysis: Test results are analyzed and interpreted.

    Testing equipment and instruments used include:

  • Microscopes

  • Spectrophotometers

  • Cell counters

  • Centrifuges

    • The testing environment requirements include:

  • Temperature control (37C 2C)

  • Humidity control (60 10)

  • Pressure control (1013 5 mbar)

    • Sample preparation procedures involve cleaning, sterilizing, and preparing the medical device for testing.

    Test results are documented and reported in accordance with standard requirements. This includes:

    1. Test report format: Results are presented in a clear and concise manner.

    2. Test result interpretation: Results are interpreted and discussed in the context of biocompatibility and safety.

    3. Certification and accreditation: Accreditation and certification details are provided.

    4. Traceability and documentation: Documentation is maintained for traceability and verification purposes.

    Electronic reporting systems used include:

  • Laboratory information management system (LIMS)

  • Document management system (DMS)

    • Confidentiality and data protection measures are implemented to ensure the security of test results.

    Performing ISO 10993-5 testing offers numerous benefits, including:

    1. Ensuring product safety and reliability

    2. Meeting regulatory requirements and compliance standards

    3. Protecting patients from potential harm caused by cytotoxic materials

    4. Preventing costly recalls and litigation

    5. Enhancing brand reputation and market credibility

    This test is essential for manufacturers seeking to demonstrate their commitment to product safety and biocompatibility.

    Conclusion

    ISO 10993-5 testing is a critical component of medical device development, ensuring the biocompatibility and safety of products. Eurolab offers comprehensive ISO 10993-5 testing services, providing accurate and reliable results. By performing this test, manufacturers can ensure compliance with regulatory requirements, protect patients from potential harm, and enhance their brand reputation.

    Appendix

  • Glossary of terms

  • References to relevant standards and regulations

  • Additional information on EUROLABs ISO 10993-5 testing services

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

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