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iso-10993-27-immunotoxicology-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 10993-28 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

Comprehensive Guide to ISO 10993-27 Immunotoxicology Testing Services Provided by Eurolab

ISO 10993-27 is an international standard that outlines the requirements for immunotoxicology testing of medical devices and materials. This standard is part of the larger ISO 10993 series, which provides guidelines for biocompatibility testing of medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-27 Immunotoxicology Testing is governed by various international and national standards. The most relevant standards include:

  • ISO 10993-1:2018: General requirements for biocompatibility testing

  • ISO 10993-2:1995: Animal welfare requirements

  • ASTM F748-08: Standard practice for selecting generic biological test methods for materials and devices

    • National standards may also apply, such as the European Unions Medical Device Regulation (MDR) and the United States FDA guidance on biocompatibility testing.

    Standard Development Organizations

    The standard development organizations responsible for creating and maintaining ISO 10993-27 include:

  • International Organization for Standardization (ISO): A global federation of national standards bodies

  • American Society for Testing and Materials (ASTM): A non-profit organization that develops and publishes voluntary consensus standards

    • Standard Evolution and Update

    Standards evolve over time as new scientific research and technological advancements become available. ISO 10993-27 has undergone several revisions since its initial publication in 1992.

    Specific Standard Numbers and Scope

    The scope of ISO 10993-27 includes:

  • ISO 10993-1: General requirements for biocompatibility testing

  • ISO 10993-17: Establishment of allowable limits for residues on the surface of medical devices

    • Industry-Specific Compliance Requirements

    Compliance with ISO 10993-27 is required for various industries, including:

  • Medical Device Industry: Companies that manufacture medical devices must ensure their products meet biocompatibility testing requirements

  • Pharmaceutical Industry: Pharmaceutical companies may require biocompatibility testing to demonstrate the safety of their products

    • ISO 10993-27 Immunotoxicology Testing is necessary for ensuring the safety and efficacy of medical devices and materials. This testing helps to:

  • Identify Potential Risks: Biocompatibility testing can identify potential risks associated with a products material or design

  • Meet Regulatory Requirements: Companies must comply with regulatory requirements, such as those outlined in ISO 10993-1 and ASTM F748-08

  • Build Customer Trust: Demonstrating biocompatibility through testing helps build customer trust and confidence

    • Business and Technical Reasons for Conducting Testing

    The business and technical reasons for conducting ISO 10993-27 Immunotoxicology Testing include:

  • Reduced Liability: Companies can reduce liability by demonstrating that their products meet biocompatibility testing requirements

  • Improved Product Safety: Biocompatibility testing helps ensure product safety, which is critical in the medical device industry

    • Consequences of Not Performing This Test

    Failure to perform ISO 10993-27 Immunotoxicology Testing can result in:

  • Regulatory Non-Compliance: Companies that fail to comply with regulatory requirements may face fines or penalties

  • Product Recall: Products that do not meet biocompatibility testing requirements may be subject to recall

    • The test conditions and methodology for ISO 10993-27 Immunotoxicology Testing include:

    1. Sample Preparation: Samples must be prepared according to specific guidelines outlined in the standard

    2. Testing Parameters: Testing parameters, such as temperature and humidity, are specified in the standard

    3. Measurement and Analysis Methods: Measurement and analysis methods used for biocompatibility testing are also specified in the standard

    The reporting and documentation requirements for ISO 10993-27 Immunotoxicology Testing include:

  • Test Report Format: The test report format must be in accordance with the standard

  • Interpretation of Test Results: The interpretation of test results is also specified in the standard

  • Certification and Accreditation Aspects: Certification and accreditation aspects are an essential part of the testing process

    • The benefits of performing ISO 10993-27 Immunotoxicology Testing include:

  • Risk Assessment and Mitigation: Biocompatibility testing helps identify potential risks associated with a products material or design

  • Quality Assurance and Compliance Benefits: Companies can ensure compliance with regulatory requirements by conducting biocompatibility testing

  • Competitive Advantages and Market Positioning: Demonstrating biocompatibility through testing can help companies gain a competitive advantage in the market

    • Why Choose Eurolab

    Eurolab is a leading provider of ISO 10993-27 Immunotoxicology Testing services. Our experienced team is dedicated to ensuring that your products meet the highest standards of biocompatibility.

    Conclusion

    ISO 10993-27 Immunotoxicology Testing is an essential part of ensuring product safety and efficacy in the medical device industry. By understanding the standard-related information, requirements, and benefits of this testing, companies can make informed decisions about their products and ensure compliance with regulatory requirements.

    We at Eurolab are committed to helping you achieve your goals by providing high-quality ISO 10993-27 Immunotoxicology Testing services. Contact us today to learn more about our services and how we can help you navigate the complex world of biocompatibility testing.

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    References

  • ISO 10993-1:2018: General requirements for biocompatibility testing

  • ASTM F748-08: Standard practice for selecting generic biological test methods for materials and devices

  • Medical Device Regulation (MDR): European Unions Medical Device Regulation

    • Table of Contents

    1. Standard-Related Information

    2. Legal and Regulatory Framework

    3. Standard Development Organizations

    4. Standard Evolution and Update

    5. Specific Standard Numbers and Scope

    6. Industry-Specific Compliance Requirements

    7. Standard Requirements and Needs

    8. Business and Technical Reasons for Conducting Testing

    9. Consequences of Not Performing This Test

    10. Test Conditions and Methodology

    11. Reporting and Documentation

    12. Why This Test Should Be Performed

    Appendix

  • Biocompatibility Testing Glossary: A list of key terms related to biocompatibility testing

  • Regulatory Requirements Checklist: A checklist of regulatory requirements for ISO 10993-27 Immunotoxicology Testing

    • ---

    We hope this comprehensive guide has provided you with a deeper understanding of ISO 10993-27 Immunotoxicology Testing and its importance in the medical device industry. If you have any further questions or would like to learn more about our services, please do not hesitate to contact us.

    Best regards,

    The Eurolab Team

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