EUROLAB
iso-10993-36-nonclinical-safety-evaluation
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 10993-28 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 10993-37 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

ISO 10993-36 Nonclinical Safety Evaluation Laboratory Testing Service: A Comprehensive Guide

The ISO 10993-36 Nonclinical Safety Evaluation testing service is governed by a range of international and national standards, including:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

  • ASTM F748-12(2020) Standard Practice for Selecting, Testing, and Evaluating Biomedical and Biomedical Engineering Materials and Systems

  • EN ISO 10993-1:2014 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • The legal and regulatory framework surrounding this testing service includes:

  • European Unions Medical Device Regulation (MDR) 2017/745

  • United States Food and Drug Administrations (FDA) regulations, including 21 CFR 800.20

  • International Organization for Standardization (ISO) standards

    • The standard development organizations involved in the creation of these standards include:

  • ISO Technical Committee 194 (TC 194): Biological evaluation of medical devices

  • ASTM F04: Medical and Surgical Materials and Devices

  • CEN/TC 206: Medical equipment

    • Standards evolve and get updated as new information becomes available, and industries adapt to changing regulations and technologies.

    The ISO 10993-36 Nonclinical Safety Evaluation testing service is required for medical devices that come into contact with the body. This includes:

  • Implantable devices

  • Contact lenses

  • Surgical instruments

  • Orthopedic devices

    • Consequences of not performing this test include:

  • Non-compliance with regulatory requirements

  • Risk of product failure or injury to patients

  • Loss of market share and reputation

    • Industries that require this testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Research institutions

    • Risk factors and safety implications include:

  • Genotoxicity, carcinogenicity, and reproductive toxicity

  • Inflammatory responses

  • Local tissue irritation or corrosion

  • Systemic toxicity

    • Quality assurance and quality control aspects of this test include:

  • Use of qualified personnel

  • Calibration and validation of equipment

  • Maintenance of testing environments

  • Documented procedures and records

    • This test contributes to product safety and reliability by:

  • Ensuring compliance with regulatory requirements

  • Identifying potential risks and hazards

  • Informing design and manufacturing decisions

  • Building customer confidence and trust

    • The ISO 10993-36 Nonclinical Safety Evaluation testing service involves a range of steps, including:

    1. Sample preparation: The medical device is prepared for testing by cleaning, cutting, or shaping as necessary.

    2. Testing equipment: Specialized equipment is used to conduct the tests, including:

    In vitro cell culture systems

    In vivo animal models

    Histopathological evaluation tools

    3. Testing environment: The test is conducted in a controlled environment with precise temperature, humidity, and pressure settings.

    4. Measurement and analysis methods: Results are measured using techniques such as:

    Cell viability assays

    Cytokine ELISA

    Histopathology

    The testing equipment and instruments used include:

  • In vitro cell culture systems (e.g., Corning Costar)

  • In vivo animal models (e.g., Sprague-Dawley rats)

  • Histopathological evaluation tools (e.g., Olympus BX51)

    • The sample preparation procedures involve:

  • Cleaning: Removal of contaminants from the device surface

  • Cutting or shaping: Preparation of the device for testing

    • The testing parameters and conditions include:

  • Temperature: 37C 1C

  • Humidity: 50 10

  • Pressure: 101.3 kPa 0.5 kPa

    • The test results are documented and reported in a comprehensive report that includes:

  • Introduction and background information

  • Test methods and equipment used

  • Results and data analysis

  • Conclusion and recommendations

    • The report format and structure include:

  • Executive summary

  • Introduction

  • Materials and methods

  • Results

  • Discussion

  • Conclusion

  • References

    • The test results are interpreted to determine the safety of the medical device, and the certification and accreditation aspects involve:

  • Validation of testing procedures and equipment

  • Verification of results against regulatory requirements

    • The benefits of performing this test include:

  • Compliance with regulatory requirements

  • Risk assessment and mitigation

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

  • Customer confidence and trust

  • Improved product safety and reliability

    • Why Choose Our Service?

    Our laboratory testing service offers:

  • Expertise in ISO 10993-36 Nonclinical Safety Evaluation testing

  • State-of-the-art equipment and facilities

  • Qualified personnel with extensive experience

  • Rapid turnaround times and competitive pricing

  • Comprehensive reporting and documentation

    • Contact us today to learn more about our ISO 10993-36 Nonclinical Safety Evaluation laboratory testing service.

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers