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iso-10993-6-local-effects-after-chemical-exposure
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 10993-5 In Vitro CytotoxicityISO 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 10993-6 Local Effects after Chemical Exposure Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The ISO 10993-6 standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices. The ISO 10993-6 standard specifically addresses the local effects after chemical exposure, providing a framework for assessing the potential harm caused by chemicals on human tissues.

Legal and Regulatory Framework

The ISO 10993-6 standard is widely recognized and adopted globally, with many countries incorporating it into their national regulations and standards. In the European Union, for example, the Medical Device Regulation (MDR) requires manufacturers to conduct biological evaluations in accordance with ISO 10993-6.

International and National Standards

  • ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for the irritation or comedogenesis potential of percutaneous medical device

  • ASTM F1671-08(2017) Standard test method for determination of the irritation potential of materials to skin and mucous membranes

  • EN ISO 10993-10:2009 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

  • TSE (Turkish Standards Institution) TS 13004:2016 Biological evaluation of medical devices - Part 6: Tests for the irritation or comedogenesis potential of percutaneous medical device

    • Standard Development Organizations

    The ISO 10993-6 standard is developed by Technical Committee 194, Biological Evaluation of Medical Devices (TC 194), which is responsible for developing and maintaining the ISO 10993 series. The TC 194 is composed of experts from various countries and industries.

    Standards Evolution and Update

    ISO standards are regularly reviewed and updated to reflect new scientific knowledge, technological advancements, and changing regulatory requirements. The ISO 10993-6 standard has undergone several revisions since its initial publication in 1992, with the latest version being published in 2016.

    Standard Compliance Requirements

    Compliance with the ISO 10993-6 standard is mandatory for medical device manufacturers that wish to demonstrate the safety and efficacy of their products. Failure to comply can result in regulatory penalties, product recalls, and damage to a companys reputation.

    Why This Test Is Needed and Required

    The ISO 10993-6 test is essential for assessing the potential harm caused by chemicals on human tissues. The test provides a critical evaluation of a medical devices safety profile, ensuring that it does not cause irritation or comedogenesis (pimple formation) to skin.

    Business and Technical Reasons for Conducting ISO 10993-6 Testing

    Conducting ISO 10993-6 testing provides numerous benefits to medical device manufacturers, including:

  • Ensuring compliance with regulatory requirements

  • Demonstrating product safety and efficacy

  • Reducing the risk of product recalls and regulatory penalties

  • Enhancing customer confidence and trust

  • Improving product competitiveness

    • Test Conditions and Methodology

    The ISO 10993-6 test involves a series of steps, including:

    1. Sample Preparation: The medical device is prepared for testing by cleaning, disinfecting, or sterilizing it.

    2. Testing Equipment and Instruments: Specialized equipment, such as dermatometers and comedogenicity meters, are used to assess skin irritation and comedogenesis potential.

    3. Testing Environment Requirements: The test is conducted in a controlled environment with specific temperature, humidity, and pressure conditions.

    4. Sample Application: The medical device is applied to the skin of an animal or human subject for a specified period.

    5. Measurement and Analysis Methods: The skin irritation and comedogenesis potential are evaluated using standardized measurement techniques.

    Test Reporting and Documentation

    The test report includes:

  • A detailed description of the test methodology

  • Results from the test, including any adverse reactions observed

  • Interpretation of the results in relation to the medical devices safety profile

    • Why This Test Should Be Performed

    Performing the ISO 10993-6 test provides numerous benefits, including:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

  • Customer confidence and trust building

    • Why Eurolab Should Provide This Service

    Eurolab has extensive expertise and experience in conducting ISO 10993-6 testing, with state-of-the-art equipment and facilities. Our qualified and certified personnel ensure that all tests are performed to the highest standards.

    Conclusion

    The ISO 10993-6 Local Effects after Chemical Exposure laboratory testing service is an essential tool for medical device manufacturers seeking to demonstrate product safety and efficacy. By understanding the standard-related information, requirements, and test conditions, manufacturers can make informed decisions about conducting this critical evaluation.

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