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iso-10993-28-evaluation-of-metallic-implants
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 10993-27 Implant Material CharacterizationISO 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 10993-28 Evaluation of Metallic Implants Laboratory Testing Service

Provided by Eurolab: A Leader in Accredited Laboratory Testing Services

ISO 10993-28 is a laboratory testing standard that evaluates the biocompatibility and safety of metallic implants used in medical devices. This standard is part of the larger ISO 10993 series, which provides guidelines for evaluating the biological safety of materials used in medical devices.

International and National Standards

The following standards govern ISO 10993-28 Evaluation of Metallic Implants testing:

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

  • ISO 10993-17:2012 (Biological evaluation of medical devices Part 17: Tests for cytotoxicity: In vitro methods)

  • ASTM F748-13 (Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices)

    • National standards may also apply, depending on the country where the testing is conducted. For example:

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

  • TSE ISO 10993-28:2018 (Biological evaluation of medical devices Part 28: Evaluation of metallic implants)

    • Standard Development Organizations

    The following organizations are responsible for developing and maintaining standards related to ISO 10993-28:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time as new technologies and research become available. New editions of standards may include updated testing methods, new evaluation criteria, or revised documentation requirements.

    Standard Compliance Requirements

    Companies that manufacture medical devices must comply with relevant standards to ensure the safety and efficacy of their products. ISO 10993-28 Evaluation of Metallic Implants testing is a critical component of this compliance process.

    Industry-specific examples:

  • Medical device manufacturers

  • Implantable device manufacturers (e.g., hip replacement, dental implants)

  • Orthopedic device manufacturers

    • Consequences of Non-Compliance

    Failure to comply with ISO 10993-28 Evaluation of Metallic Implants testing can result in product recalls, regulatory fines, and loss of market share.

    Why this Test is Needed and Required

    ISO 10993-28 Evaluation of Metallic Implants testing ensures that medical devices containing metallic implants meet the required standards for biocompatibility and safety. This test is essential to prevent adverse reactions, ensure patient safety, and maintain regulatory compliance.

    Business and Technical Reasons for Conducting ISO 10993-28 Testing

    Conducting this test demonstrates a companys commitment to quality assurance, regulatory compliance, and customer satisfaction.

    Industry-specific examples:

  • Medical device manufacturers must comply with regulatory requirements to avoid product recalls.

  • Implantable device manufacturers need to ensure the biocompatibility of their products to prevent adverse reactions.

    • Risk Factors and Safety Implications

    Failure to conduct ISO 10993-28 Evaluation of Metallic Implants testing can result in serious health consequences for patients, including:

  • Adverse reactions

  • Device failure

  • Infection

    • Consequences of Not Performing this Test

    Non-compliance with ISO 10993-28 Evaluation of Metallic Implants testing can lead to regulatory fines, product recalls, and loss of market share.

    Quality Assurance and Quality Control Aspects

    ISO 10993-28 Evaluation of Metallic Implants testing is an essential component of quality assurance and control processes. This test ensures that products meet the required standards for biocompatibility and safety.

    Industry-specific examples:

  • Medical device manufacturers must ensure their products comply with regulatory requirements.

  • Implantable device manufacturers need to demonstrate the biocompatibility of their products to patients and healthcare professionals.

    • Step-by-Step Explanation of the Test

    The ISO 10993-28 Evaluation of Metallic Implants testing process involves several steps:

    1. Sample Preparation: The test sample is prepared according to specific guidelines.

    2. Testing Equipment and Instruments: Appropriate testing equipment and instruments are used to evaluate the biocompatibility of the metallic implant.

    3. Testing Environment Requirements: The testing environment must meet specific requirements for temperature, humidity, pressure, etc.

    4. Measurement and Analysis Methods: Measurements are taken using standardized methods, and data is analyzed according to specific criteria.

    Testing Parameters and Conditions

    The following parameters and conditions are critical in the ISO 10993-28 Evaluation of Metallic Implants testing process:

  • Temperature

  • Humidity

  • Pressure

  • pH

  • Concentration

    • Data Collection and Recording Procedures

    Data is collected and recorded using standardized methods, including:

  • Spectrophotometry

  • Chromatography

  • Infrared spectroscopy

    • Test Reports and Certificates of Compliance

    The test report and certificate of compliance are essential documentation for regulatory purposes.

    Industry-specific examples:

  • Medical device manufacturers must provide test reports to regulatory authorities.

  • Implantable device manufacturers need to demonstrate compliance with regulatory requirements.

    • Conclusions and Recommendations

    ISO 10993-28 Evaluation of Metallic Implants testing is a critical component of quality assurance, regulatory compliance, and customer satisfaction. Companies that manufacture medical devices containing metallic implants must comply with this standard to ensure the safety and efficacy of their products.

    By conducting ISO 10993-28 Evaluation of Metallic Implants testing, companies can:

  • Prevent adverse reactions

  • Ensure patient safety

  • Maintain regulatory compliance

    • Contact Eurolab for accredited laboratory testing services. Our team is committed to providing expert guidance on ISO 10993-28 Evaluation of Metallic Implants testing.

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    This comprehensive guide provides an in-depth overview of the ISO 10993-28 Evaluation of Metallic Implants testing process, including standard-related information, requirements and needs, and test conditions and methodology. By understanding this critical component of quality assurance and regulatory compliance, companies can ensure the safety and efficacy of their medical devices containing metallic implants.

    Eurolab is committed to providing expert guidance on ISO 10993-28 Evaluation of Metallic Implants testing. Contact us today for accredited laboratory testing services and ensure your companys compliance with regulatory requirements.

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