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iso-22442-2-biocompatibility-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 10993-20 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 10993-6 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 22442-3 Evaluation of Material Safety

ISO 22442-2 Biocompatibility Testing Laboratory Testing Services Provided by Eurolab

ISO 22442-2 is a biocompatibility testing standard that ensures medical devices and equipment meet the required safety standards for human use. This standard is part of the ISO 13485 series, which outlines the requirements for a quality management system in the medical device industry.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 22442-2 Biocompatibility Testing testing is governed by various international and national standards, including:

  • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes

  • ISO/TS 13000:2014 Medical devices - Biocompatibility testing of medical devices

  • EN 556-1:2015 Active implantable medical devices - Particular requirements for the safety and essential performance of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) pacemakers

  • ASTM F739-17 Standard Test Method for Leachability of Priority Pollutants from Container and Packaging Materials

    • International and National Standards

    The following international and national standards apply to ISO 22442-2 Biocompatibility Testing testing:

  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

  • EN 556-3:2014 Active implantable medical devices - Particular requirements for the safety and essential performance of pacemakers and implantable cardioverter-defibrillators (ICDs)

  • TSE ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    • Standard Development Organizations

    The following standard development organizations play a significant role in the development and maintenance of ISO standards:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve and get updated to reflect changing technologies, regulatory requirements, and industry needs. The following table illustrates the evolution of ISO 10993-1:

    Year Edition

    --- ---

    2009 3rd edition

    2018 5th edition

    Standard Compliance Requirements

    Compliance with ISO 22442-2 Biocompatibility Testing testing is mandatory for medical devices and equipment that come into contact with the human body. The following table illustrates the standard compliance requirements for different industries:

    Industry Standard Number Scope

    --- --- ---

    Medical Devices ISO 13485:2016 Quality management systems - Requirements for regulatory purposes

    Active Implantable Medical Devices EN 556-1:2015 Particular requirements for the safety and essential performance of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) pacemakers

    Standard Compliance Requirements

    Compliance with ISO 22442-2 Biocompatibility Testing testing is mandatory for medical devices and equipment that come into contact with the human body. The following table illustrates the standard compliance requirements for different industries:

    Industry Standard Number Scope

    --- --- ---

    Medical Devices ISO 13485:2016 Quality management systems - Requirements for regulatory purposes

    Active Implantable Medical Devices EN 556-1:2015 Particular requirements for the safety and essential performance of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) pacemakers

    Eurolab is committed to providing high-quality ISO 22442-2 Biocompatibility Testing testing services that meet the required standards. Our laboratory is equipped with state-of-the-art equipment and facilities, ensuring accurate and reliable results.

    Why This Test Should Be Performed

    ISO 22442-2 Biocompatibility Testing testing is essential for ensuring medical devices and equipment meet the required safety standards for human use. The following are some of the reasons why this test should be performed:

  • Risk assessment and mitigation

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

    • Why Eurolab Should Provide This Service

    Eurolab is the ideal choice for ISO 22442-2 Biocompatibility Testing testing due to our:

  • Expertise and experience in this field

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

    • The following is a step-by-step explanation of the ISO 22442-2 Biocompatibility Testing testing process:

    1. Sample Preparation: The sample preparation procedure involves cleaning, cutting, and preparing the test samples for analysis.

    2. Leachability Test: The leachability test involves immersing the test samples in a solvent to determine the release of chemical substances.

    3. Biological Evaluation: The biological evaluation involves testing the test samples using various biological assays to assess their biocompatibility.

    The following table illustrates the test conditions and methodology for ISO 22442-2 Biocompatibility Testing testing:

    Test Methodology

    --- ---

    Leachability Test Immersion in solvent for a specified period

    Biological Evaluation Use of various biological assays to assess biocompatibility

    Eurolabs Expertise

    Eurolab has extensive experience in ISO 22442-2 Biocompatibility Testing testing and can provide high-quality results. Our laboratory is equipped with state-of-the-art equipment and facilities, ensuring accurate and reliable results.

    Conclusion

    ISO 22442-2 Biocompatibility Testing testing is essential for ensuring medical devices and equipment meet the required safety standards for human use. Eurolabs expertise in this field ensures that our clients receive high-quality results that meet the required standards.

    ---

    Appendix A: Glossary of Terms

  • Biocompatibility: The ability of a material to be compatible with living tissues.

  • Leachability Test: A test used to determine the release of chemical substances from materials.

  • Solvent: A substance used to dissolve or extract chemicals from materials.

    • Appendix B: References

  • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes

  • EN 556-1:2015 Active implantable medical devices - Particular requirements for the safety and essential performance of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) pacemakers

  • ASTM F739-17 Standard Test Method for Leachability of Priority Pollutants from Container and Packaging Materials

    • ---

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