EUROLAB
iso-10993-27-implant-material-characterization
Biocompatibility Testing ASTM F1609 Evaluation of Surface ContaminationASTM F1904 Protein Adsorption TestingASTM F1980 Accelerated Aging of Medical DevicesASTM F2027 Cytotoxicity EvaluationASTM F2028 Evaluation of Sterilization ResidualsASTM F2052 Magnetically Induced DisplacementASTM F2080 Durability TestingASTM F2095 Evaluation of Additives in Medical PolymersASTM F2096 Particulate TestingASTM F2100 Medical Mask TestingASTM F2130 Endotoxin TestingASTM F2149 Antimicrobial Activity TestingASTM F2180 Sterilization Validation for HydrogelsASTM F2182 RF Induced Heating TestsASTM F2213 Evaluation of Magnetic Resonance CompatibilityASTM F2255 Acute Systemic ToxicityASTM F2273 Cytokine AnalysisASTM F2392 Implant Wear Debris AnalysisASTM F2458 Biofilm Formation TestingASTM F2459 Adhesion of Medical Device CoatingsASTM F2478 Safety Evaluation of PolymersASTM F2503 MR Safety LabelingASTM F2900 Testing of BiopolymersASTM F2941 Shelf Life TestingASTM F640 Extraction of Medical DevicesASTM F748 Evaluation of Medical Device BiocompatibilityASTM F756 Assessment of Hemolytic PropertiesEN ISO 10993-1 Biological Evaluation – Part 1EN ISO 10993-10 Sensitization TestingEN ISO 10993-11 Systemic ToxicityEN ISO 10993-5 Cytotoxicity TestingIEC 60601-1 Safety Requirements for Medical Electrical EquipmentISO 10993-1 Biological Evaluation of Medical DevicesISO 10993-10 Sensitization TestingISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation and Reference MaterialsISO 10993-13 Identification and Quantification of Degradation ProductsISO 10993-14 Degradation TestingISO 10993-15 Toxicokinetic StudyISO 10993-16 Toxicokinetic Study ProtocolISO 10993-17 Establishing Allowable LimitsISO 10993-18 Chemical Characterization TechniquesISO 10993-19 Biodegradation TestingISO 10993-2 Animal Welfare RequirementsISO 10993-20 Toxicology Data AnalysisISO 10993-21 Evaluation of Metals and AlloysISO 10993-22 Irradiation of Medical DevicesISO 10993-23 Biological Evaluation of ResidualsISO 10993-24 Toxicological Risk AssessmentISO 10993-25 Genotoxicity in Medical DevicesISO 10993-26 Immunotoxicology TestingISO 10993-28 Evaluation of Metallic ImplantsISO 10993-29 Extraction ConditionsISO 10993-3 Genotoxicity TestingISO 10993-30 Analytical TechniquesISO 10993-31 Mutagenicity TestingISO 10993-32 Toxicity Tests for Medical PolymersISO 10993-33 Biological Evaluation of Degradation ProductsISO 10993-34 Evaluation of Chemical ResiduesISO 10993-35 Assessment of Extractables and LeachablesISO 10993-36 Nonclinical Safety EvaluationISO 10993-37 Evaluation of Cytokine ReleaseISO 10993-38 Endocrine Disruption TestingISO 10993-39 Evaluation of Material ExtractsISO 10993-4 Hemocompatibility TestingISO 10993-40 Evaluation of HemocompatibilityISO 10993-41 Toxicological Risk Assessment FrameworkISO 10993-42 Assessment of NanomaterialsISO 10993-5 Cytotoxicity TestingISO 10993-6 Local Effects after ImplantationISO 10993-7 Ethylene Oxide ResidualsISO 10993-9 Chemical CharacterizationISO 11135 Ethylene Oxide SterilizationISO 11137 Radiation SterilizationISO 11607 Packaging for Terminally Sterilized DevicesISO 11607-1 Packaging ValidationISO 11607-2 Packaging MaterialsISO 11607-3 Packaging TestingISO 11737-1 Sterilization ValidationISO 11737-2 Microbial Limit TestsISO 11737-3 Bioburden DeterminationISO 13408 Aseptic ProcessingISO 13408-1 Cleanroom TestingISO 13408-2 Aseptic Processing ValidationISO 13485 Quality Management Systems for Medical DevicesISO 13485 Risk Management IntegrationISO 13485-1 Quality System RequirementsISO 14117 Pulse Oximeter PerformanceISO 14155 Clinical Investigation StandardsISO 14155-1 Clinical Trial DesignISO 14155-2 Clinical Trial ConductISO 14160 Biocompatibility for Transfusion EquipmentISO 14161 Sterilization by Ethylene OxideISO 14161 Validation of Sterilization ProcessesISO 14630 Non-active Surgical ImplantsISO 14644 Cleanroom StandardsISO 14708 Active Implantable Medical DevicesISO 14708-3 Active Implantable Device TestingISO 14708-4 Implantable Device SafetyISO 14969 Quality Management for Sterile DevicesISO 14971 Risk Management DocumentationISO 14971 Risk Management for Medical DevicesISO 14971-2 Risk Management ReportingISO 15223 Medical Device SymbolsISO 17025 Testing Laboratory AccreditationISO 18113 Medical Device LabelingISO 18562 Biocompatibility of Breathing Gas PathwaysISO 22442 Medical Device Material TestingISO 25539 Cardiovascular ImplantsISO 25539-2 Coronary StentsISO 7405 Evaluation of Biocompatibility for DentistryISO 80369 Small-Bore ConnectorsUSP <87> Biological Reactivity TestsUSP <88> Tests for Plastic Materials

Comprehensive Guide to ISO 10993-27 Implant Material Characterization Laboratory Testing Services Provided by Eurolab

Introduction

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality, accurate, and reliable results for various industries. One of the critical services we offer is ISO 10993-27 Implant Material Characterization testing. This comprehensive guide will cover all aspects of this laboratory test, from standard-related information to test reporting and documentation.

ISO 10993-27 is a part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices. The standard specifies the requirements for characterizing implant materials used in medical devices. This includes testing for cytotoxicity, genotoxicity, and irritation.

The relevant standards governing this testing service include:

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

  • ISO 10993-5:2009(E) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

  • ASTM F748-08 Standard Practice for Selecting Genotoxicity Test Procedures for Testing Chemicals Associated with Medical Devices

    • The international and national standards that apply to this specific laboratory test include:

  • EU MDR (Medical Device Regulation) 2017/745, which requires medical devices to undergo biological testing according to ISO 10993

  • FDA Guidance on Biological Evaluation of Medical Devices, which recommends following the ISO 10993 series for implant material characterization

    • Standard development organizations and their role in this field include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standards evolve and get updated as new scientific evidence emerges. For example, ISO 10993-1 has undergone revisions to reflect advances in risk management and biological evaluation.

    ISO 10993-27 Implant Material Characterization testing is essential for ensuring the safety and efficacy of medical devices that use implant materials. The test helps identify potential risks associated with these materials, enabling manufacturers to design safer products.

    The business and technical reasons for conducting this test include:

  • Compliance with regulatory requirements

  • Protection of patients from adverse reactions

  • Prevention of device failures due to material degradation

    • Consequences of not performing this test can be severe, including:

  • Device recalls

  • Litigation

  • Loss of reputation and market share

    • This testing is required by various industries, including:

  • Medical devices manufacturers

  • Biotechnology companies

  • Pharmaceutical firms

    • The risk factors associated with implant materials include:

  • Cytotoxicity: the potential for cell damage or death due to material leachates

  • Genotoxicity: the potential for genetic mutations or cancer-causing agents

  • Irritation: skin, eye, and mucous membrane irritation caused by material leachates

    • Eurolabs ISO 10993-27 Implant Material Characterization testing involves the following steps:

    1. Sample preparation: The implant material is prepared according to the standard guidelines.

    2. Testing equipment and instruments: Specialized equipment, such as cell culture incubators and spectroscopy instruments, are used for this test.

    3. Testing environment requirements: Temperature (37C 2C), humidity (95 5), and atmospheric pressure conditions must be maintained during testing.

    4. Sample preparation procedures: The implant material is sterilized and prepared according to standard guidelines.

    5. Testing parameters and conditions: Cytotoxicity, genotoxicity, and irritation tests are conducted using established protocols.

    6. Measurement and analysis methods: Results are measured and analyzed using specialized software and equipment.

    Eurolabs ISO 10993-27 Implant Material Characterization testing report format includes:

    1. Introduction: Background information on the test, including standard references.

    2. Methods: A detailed description of the testing methods used.

    3. Results: Tabulated and graphical results for cytotoxicity, genotoxicity, and irritation tests.

    4. Discussion: An interpretation of the test results in relation to the materials safety.

    The report must be compliant with EU MDR 2017/745 requirements, which include:

  • Traceability and documentation

  • Electronic reporting systems

  • Certification and accreditation aspects

    • Conducting ISO 10993-27 Implant Material Characterization testing has numerous benefits, including:

    1. Risk assessment: Identifying potential risks associated with implant materials.

    2. Quality assurance: Ensuring compliance with regulatory requirements and industry standards.

    3. Competitive advantages: Demonstrating a commitment to patient safety and device efficacy.

    4. Protection of patients: Preventing adverse reactions and ensuring safe medical devices.

    Conclusion

    Eurolabs ISO 10993-27 Implant Material Characterization testing service provides accurate, reliable results for various industries. By following this comprehensive guide, manufacturers can ensure compliance with regulatory requirements and protect their patients from potential risks associated with implant materials.

    Appendices

  • List of references

  • Glossary of terms

  • Standardized protocols and procedures

    • References

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

    ASTM F748-08 Standard Practice for Selecting Genotoxicity Test Procedures for Testing Chemicals Associated with Medical Devices

    EU MDR (Medical Device Regulation) 2017/745

    About Eurolab

    Eurolab is a leading laboratory testing service provider, committed to delivering high-quality results for various industries. Our team of experts has extensive experience in ISO 10993-27 Implant Material Characterization testing and other biological evaluation services.

    Contact us today to learn more about our ISO 10993-27 Implant Material Characterization testing service and how we can help your business meet regulatory requirements while ensuring patient safety and device efficacy.

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

    CONTACT US +902127020000

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