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iso-10993-20-sensitization-testing
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 10993-21 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 10993-5 In Vitro CytotoxicityISO 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

ISO 10993-20 Sensitization Testing Laboratory Testing Service: A Comprehensive Guide

ISO 10993-20 Sensitization Testing is a laboratory testing service provided by Eurolab, which conforms to the international standard ISO 10993-20. This standard specifies the requirements for the assessment of sensitization, which is an essential aspect of medical device testing.

Understanding ISO 10993-20

ISO 10993-20 is part of the ISO 10993 series, which deals with the biological evaluation of medical devices. This standard focuses on the assessment of sensitization, which refers to the immune systems response to a substance or material. Sensitization can lead to allergic reactions or other adverse effects.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-20 is governed by various international and national standards. The key regulations include:

  • ISO 10993-1: General requirements for biological evaluation of medical devices

  • ISO 10993-2: Animal welfare requirements

  • ISO 10993-3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

  • EN ISO 10993-20: Sensitization testing

    • International and National Standards

    The following standards apply to ISO 10993-20:

  • EU Medical Device Regulation (MDR): Regulates the safety and performance of medical devices in the European Union.

  • US FDA Guidance on Biological Evaluation of Medical Devices: Provides guidance on the biological evaluation of medical devices in the United States.

    • Standard Development Organizations

    The following organizations play a crucial role in standard development:

  • International Organization for Standardization (ISO): Develops and publishes international standards, including ISO 10993-20.

  • American Society for Testing and Materials (ASTM): Develops and publishes technical standards for various industries.

    • Standard Evolution

    Standards evolve over time to reflect advances in technology and scientific knowledge. Eurolab stays up-to-date with the latest developments and updates its testing services accordingly.

    Specific Standard Numbers and Scope

    The following standard numbers are relevant to ISO 10993-20:

  • ISO 10993-1:2018: General requirements for biological evaluation of medical devices

  • ISO 10993-2:2020: Animal welfare requirements

  • EN ISO 10993-20:2020: Sensitization testing

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for medical device manufacturers to ensure the safety and performance of their products.

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    Why ISO 10993-20 Testing is Required

    ISO 10993-20 testing is essential for ensuring the safety and performance of medical devices. The consequences of not performing this test can be severe, including:

  • Adverse reactions: Sensitization can lead to allergic reactions or other adverse effects.

  • Regulatory non-compliance: Failure to comply with regulatory requirements can result in product recalls, fines, or even legal action.

    • Business and Technical Reasons for Conducting ISO 10993-20 Testing

    Conducting ISO 10993-20 testing is necessary for several reasons:

  • Quality assurance: Testing ensures that medical devices meet safety and performance standards.

  • Regulatory compliance: Compliance with regulatory requirements ensures product approval and market access.

    • Industries and Sectors That Require ISO 10993-20 Testing

    The following industries require ISO 10993-20 testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Cosmetic manufacturers

    • Risk Factors and Safety Implications

    Sensitization can have severe consequences, including:

  • Allergic reactions: Sensitization can lead to allergic reactions or other adverse effects.

  • Product recalls: Failure to comply with regulatory requirements can result in product recalls.

    • ---

    Conducting ISO 10993-20 Testing

    ISO 10993-20 testing involves several steps:

    1. Sample preparation: Prepare the sample according to the standards requirements.

    2. Testing equipment: Use calibrated testing equipment, such as a skin sensitization test system.

    3. Testing environment: Conduct testing in a controlled environment with specific temperature and humidity conditions.

    Testing Parameters and Conditions

    The following parameters are critical for ISO 10993-20 testing:

  • Temperature: Maintain a temperature range of 22C to 25C (72F to 77F).

  • Humidity: Maintain a relative humidity range of 40 to 60.

    • Measurement and Analysis Methods

    Measurements and analysis are critical for accurate results. The following methods are used:

  • Skin sensitivity testing: Measure the skins sensitivity using a skin sensitization test system.

  • Histopathology: Examine tissue samples under a microscope.

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    Conclusion

    ISO 10993-20 Sensitization Testing is an essential aspect of medical device testing, ensuring the safety and performance of products. By understanding the standard-related information, standard requirements and needs, and conducting the tests according to established protocols, manufacturers can ensure compliance with regulatory requirements and minimize the risk of adverse reactions.

    Eurolabs team of experts provides comprehensive guidance on ISO 10993-20 testing, helping medical device manufacturers navigate the complex regulatory landscape. Contact us today to learn more about our services.

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    References

  • ISO 10993-1:2018: General requirements for biological evaluation of medical devices

  • ISO 10993-2:2020: Animal welfare requirements

  • EN ISO 10993-20:2020: Sensitization testing

  • EU Medical Device Regulation (MDR): Regulates the safety and performance of medical devices in the European Union.

  • US FDA Guidance on Biological Evaluation of Medical Devices: Provides guidance on the biological evaluation of medical devices in the United States.

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