EUROLAB
iso-14155-2-clinical-trial-conduct
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 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 14155-2 Clinical Trial Conduct Laboratory Testing Service: Eurolabs Expertise

ISO 14155-2 is a harmonized standard that defines the requirements for clinical trial conduct, including laboratory testing. This standard is published by the International Organization for Standardization (ISO) and is widely adopted across various industries.

Legal and Regulatory Framework Surrounding ISO 14155-2 Clinical Trial Conduct Testing

The legal and regulatory framework surrounding clinical trial conduct, including laboratory testing, is complex and involves multiple stakeholders. In Europe, the European Unions Clinical Trials Regulation (CTR) governs clinical trials, while in the United States, the Food and Drug Administration (FDA) regulates clinical trials.

International and National Standards that Apply to ISO 14155-2 Clinical Trial Conduct Testing

Several international and national standards apply to ISO 14155-2 clinical trial conduct testing. Some of these include:

  • ISO 9001:2015 Quality Management System

  • ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories

  • ICH E6(R2): Good Clinical Practice (GCP)

  • FDAs Guidance on Good Laboratory Practices (GLP)

    • Standard Development Organizations and Their Role

    Standard development organizations, such as ISO, play a crucial role in developing standards that ensure consistency and compliance across industries. These organizations work closely with industry experts to develop standards that address specific needs and requirements.

    Evolution of Standards and Updates

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. The standard development process involves several stages, including drafting, review, approval, and publication.

    ISO 14155-2 clinical trial conduct testing is essential for ensuring the quality, safety, and efficacy of medical devices and pharmaceuticals. This testing is required by regulatory agencies to ensure that products meet specific requirements before they are approved for use in humans.

    Business and Technical Reasons for Conducting ISO 14155-2 Clinical Trial Conduct Testing

    Business and technical reasons for conducting ISO 14155-2 clinical trial conduct testing include:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Building customer confidence and trust

  • Gaining international market access and trade facilitation

  • Supporting innovation and research development

    • Consequences of Not Performing this Test

    Failure to perform ISO 14155-2 clinical trial conduct testing can have serious consequences, including:

  • Non-compliance with regulatory requirements

  • Product recalls and withdrawals

  • Loss of customer trust and confidence

  • Reduced market access and trade facilitation

  • Inhibition of innovation and research development

    • Industries and Sectors that Require this Testing

    Several industries and sectors require ISO 14155-2 clinical trial conduct testing, including:

  • Pharmaceutical and biotechnology companies

  • Medical device manufacturers

  • Clinical research organizations (CROs)

  • Contract research organizations (CROs)

    • Risk Factors and Safety Implications

    Risk factors and safety implications associated with not performing ISO 14155-2 clinical trial conduct testing include:

  • Product liability claims

  • Patient harm and injury

  • Damage to reputation and brand image

  • Loss of business and revenue

    • ISO 14155-2 clinical trial conduct testing involves several steps, including:

    1. Test planning and preparation

    2. Sample collection and preparation

    3. Testing and analysis

    4. Data recording and reporting

    5. Quality control and assurance

    Equipment and Instruments Used

    Several pieces of equipment and instruments are used during ISO 14155-2 clinical trial conduct testing, including:

  • Analytical balances and scales

  • pH meters and titrators

  • Spectrophotometers and chromatographs

  • Microscopes and stereomicroscopes

    • ISO 14155-2 clinical trial conduct testing involves detailed reporting and documentation. The report format and structure include:

    1. Introduction and background information

    2. Study design and methodology

    3. Results and discussion

    4. Conclusion and recommendations

    5. Appendices and references

    ISO 14155-2 clinical trial conduct testing offers several benefits, including:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Building customer confidence and trust

  • Gaining international market access and trade facilitation

  • Supporting innovation and research development

    • Competitive Advantages of Having this Testing Performed

    Several competitive advantages are associated with having ISO 14155-2 clinical trial conduct testing performed, including:

  • Reduced product liability claims

  • Improved patient safety and outcomes

  • Enhanced reputation and brand image

  • Increased market access and trade facilitation

  • Faster time-to-market for products

    • Eurolab is a leading provider of laboratory testing services, with extensive experience in ISO 14155-2 clinical trial conduct testing. Our team of experts offers:

    1. State-of-the-art facilities and equipment

    2. High-quality testing services

    3. Comprehensive reporting and documentation

    4. Regulatory compliance and support

    5. Timely and cost-effective solutions

    Conclusion

    ISO 14155-2 clinical trial conduct testing is a critical component of ensuring product safety, efficacy, and regulatory compliance. Eurolabs expertise in this area ensures that clients meet the highest standards of quality and compliance.

    By choosing Eurolab for your ISO 14155-2 clinical trial conduct testing needs, you can ensure:

    1. Regulatory compliance

    2. Product safety and efficacy

    3. Customer confidence and trust

    4. International market access and trade facilitation

    5. Innovation and research development

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

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