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usp-87-biological-reactivity-tests
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 10993-36 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 <88> Tests for Plastic Materials

USP <87> Biological Reactivity Tests Laboratory Testing Service Provided by Eurolab: A Comprehensive Guide

Standard-Related Information

The United States Pharmacopeia (USP) <87> Biological Reactivity Tests is a standard that governs the testing of materials for their potential to induce biological reactivity, such as irritation or sensitization. This standard is widely recognized and adopted globally, with many countries incorporating its requirements into their national regulations.

Relevant Standards

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

  • ASTM F739-18 Standard Test Method for Permeation of Liquids through Protective Clothing Materials under Conditions of Continuous Contact

  • EN 14605:2009A1:2010 Medical gloves for surgical, examination and procedural use Requirements and testing

  • TSE (Turkish Standards Institution) TS EN ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • International and National Standards

    The USP <87> Biological Reactivity Tests standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices. Many countries have adopted or referenced these standards in their national regulations.

  • In the United States, the FDA requires compliance with the USP <87> standard for medical device manufacturers.

  • In Europe, the EU Medical Device Regulation (MDR) and the ISO 10993 series are directly applicable to medical devices.

    • Standard Development Organizations

    The International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN) are prominent standard development organizations that contribute to the development of standards related to biological reactivity testing.

    Evolution of Standards

    Standards evolve as new scientific evidence emerges, or regulatory requirements change. For example:

  • The latest revision of ISO 10993-1:2018 includes updated guidelines for evaluating cytotoxicity and sensitization.

  • EN 14605:2009A1:2010 was revised to include new test methods for assessing the permeability of medical gloves.

    • Standard Compliance Requirements

    Compliance with USP <87> Biological Reactivity Tests requires manufacturers to:

  • Conduct biological reactivity testing on their products, as specified in the standard.

  • Evaluate and manage risks associated with biological reactivity.

  • Document and maintain records of testing and evaluation procedures.

    • Industries and Sectors Requiring This Testing

    Medical device manufacturers, pharmaceutical companies, and suppliers of raw materials for medical devices or pharmaceuticals require compliance with USP <87> Biological Reactivity Tests.

    Risk Factors and Safety Implications

    Biological reactivity can lead to adverse reactions in humans, such as irritation, sensitization, or even life-threatening conditions. Manufacturers must mitigate these risks through testing and evaluation.

    Quality Assurance and Quality Control Aspects

    Compliance with USP <87> Biological Reactivity Tests requires manufacturers to establish quality assurance and control procedures for:

  • Testing and evaluation

  • Documentation and record-keeping

  • Risk management and mitigation

    • Contribution to Product Safety and Reliability

    Biological reactivity testing contributes significantly to product safety and reliability by identifying potential hazards and enabling risk mitigation.

    Competitive Advantages of Having This Testing Performed

    Manufacturers that comply with USP <87> Biological Reactivity Tests can:

  • Enhance customer confidence and trust

  • Improve market access and trade facilitation

  • Gain competitive advantages through innovation and research development support

    • Cost-Benefit Analysis of Performing This Test

    While the cost of testing may seem significant, non-compliance can lead to more severe consequences, such as product recalls or regulatory penalties.

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    Test Conditions and Methodology

    Step-by-Step Explanation of the Test Conducted

    1. Sample Preparation: Prepare the test samples according to the standard requirements.

    2. Testing Equipment and Instruments: Utilize calibrated and validated testing equipment, such as cytotoxicity assays and sensitization tests.

    3. Testing Environment Requirements: Maintain a controlled environment with specified temperature, humidity, and pressure conditions.

    4. Measurement and Analysis Methods: Apply statistical analysis to test results.

    Calibration and Validation Procedures

  • Calibrate testing equipment according to the manufacturers instructions.

  • Validate testing methods through interlaboratory comparisons or proficiency testing.

    • Quality Control Measures During Testing

  • Implement quality control measures, such as testing sample duplicates or using positive controls.

  • Document and maintain records of testing procedures.

    • Data Collection and Recording Procedures

  • Collect data according to the standard requirements.

  • Maintain accurate and complete records of testing and evaluation procedures.

    • Testing Timeframes and Duration

  • Conduct testing within specified timeframes (e.g., 24 hours for cytotoxicity assays).

  • Complete testing in a reasonable timeframe, taking into account test complexity and sample availability.

    • ---

    Test Reporting and Documentation

    How Test Results Are Documented and Reported

    1. Reporting Format: Provide results in the required reporting format.

    2. Documentation Requirements: Maintain accurate and complete records of testing procedures, including:

    Test methods used

    Sample preparation and handling procedures

    Calibration and validation records

    Quality control measures implemented

    Example Reporting Format

    Test Method Results

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    Cytotoxicity Assay 10.5 1.2 μg/mL

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    Conclusion

    USP <87> Biological Reactivity Tests is a critical standard for ensuring product safety and reliability in the medical device and pharmaceutical industries. Manufacturers must comply with this standard to mitigate risks associated with biological reactivity. By following this comprehensive guide, manufacturers can ensure compliance and enhance their products quality.

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    Appendix

  • Sample testing protocol

  • Example calibration record

  • Interlaboratory comparison results

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    References

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

    2. ASTM F739-18 Standard Test Method for Permeation of Liquids through Protective Clothing Materials under Conditions of Continuous Contact.

    3. EN 14605:2009A1:2010 Medical gloves for surgical, examination and procedural use Requirements and testing.

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    Eurolab offers a wide range of services related to USP <87> Biological Reactivity Tests, including:

  • Testing and evaluation

  • Calibration and validation of equipment

  • Interlaboratory comparisons and proficiency testing

    • For more information or to request our services, please contact us at infoeurolab.com(mailto:infoeurolab.com) or 44 (0) 20 7183 0044.

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

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