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astm-f748-evaluation-of-medical-device-biocompatibility
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 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 <87> Biological Reactivity TestsUSP <88> Tests for Plastic Materials

ASTM F748 Evaluation of Medical Device Biocompatibility Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide

Standard-Related Information

The ASTM F748 Evaluation of Medical Device Biocompatibility testing is a critical requirement for the medical device industry. This laboratory test evaluates the biocompatibility of medical devices to ensure they are safe and effective for use in humans.

Overview of Relevant Standards

  • ISO 10993: Biological evaluation of medical devices

  • ASTM F748: Standard practice for selectng substrates and conducting accelerated aging of materials used in medical devices that require implantation as an integral part of a medical device

  • EN ISO 1463: Biological evaluation of medical devices - Tests for the isolation and identification of viable microorganisms from clinical specimens from patients with implants or other invasive medical devices

  • TSE (Turkish Standards Institution) 16345: Biological evaluation of medical devices

    • These standards provide guidelines for evaluating the biocompatibility of medical devices. The ASTM F748 standard specifically addresses the testing of substrates and accelerated aging of materials used in medical devices.

    International and National Standards

    The international standards governing ASTM F748 Evaluation of Medical Device Biocompatibility testing include:

  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing

  • ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

    • National standards may also apply, such as the European Unions Medical Device Regulation (MDR) and the FDAs guidance documents.

    Standard Development Organizations

    The International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN) are among the organizations responsible for developing standards related to medical device biocompatibility testing.

    Evolution of Standards

    Standards evolve as new technologies and research become available. The ASTM F748 standard has undergone several revisions since its initial publication in 1991.

    Standard Numbers and Scope

  • ASTM F748: Standard practice for selectng substrates and conducting accelerated aging of materials used in medical devices that require implantation as an integral part of a medical device

    • Covers the selection of substrates and accelerated aging of materials used in medical devices

    Provides guidelines for testing and evaluation

    Standard Compliance Requirements

    Compliance with ASTM F748 Evaluation of Medical Device Biocompatibility testing is mandatory for certain industries, including:

  • Medical device manufacturers

  • Regulatory authorities

  • Quality management system (QMS) auditors

  • Industry consultants

    • Failure to comply can result in product recalls, fines, and loss of business reputation.

    Standard Requirements and Needs

    The ASTM F748 Evaluation of Medical Device Biocompatibility testing is necessary for several reasons:

    1. Product Safety: Ensures medical devices are safe for use in humans.

    2. Regulatory Compliance: Complies with international and national standards governing medical device biocompatibility testing.

    3. Quality Assurance: Demonstrates a commitment to quality management and risk reduction.

    Business and Technical Reasons

    Conducting ASTM F748 Evaluation of Medical Device Biocompatibility testing is essential for:

    1. Competitive Advantage: Demonstrates a companys commitment to product safety and quality.

    2. Risk Mitigation: Reduces the risk of product recalls, fines, and loss of business reputation.

    3. Compliance with Regulations: Ensures compliance with international and national standards governing medical device biocompatibility testing.

    Consequences of Not Performing This Test

    Failure to conduct ASTM F748 Evaluation of Medical Device Biocompatibility testing can result in:

    1. Product Recalls

    2. Fines and Penalties

    3. Loss of Business Reputation

    4. Regulatory Action

    Industries and Sectors That Require This Testing

    The following industries and sectors require ASTM F748 Evaluation of Medical Device Biocompatibility testing:

    1. Medical Device Manufacturers

    2. Pharmaceutical Companies

    3. Biotechnology Firms

    4. Research Institutions

    Risk Factors and Safety Implications

    Failure to conduct ASTM F748 Evaluation of Medical Device Biocompatibility testing can result in adverse health effects, product recalls, and loss of business reputation.

    Quality Assurance and Quality Control Aspects

    ASTM F748 Evaluation of Medical Device Biocompatibility testing is an essential component of quality assurance and quality control programs.

    Contribution to Product Safety and Reliability

    This laboratory test contributes to:

    1. Product Safety: Ensures medical devices are safe for use in humans.

    2. Reliability: Demonstrates a commitment to product reliability and performance.

    Competitive Advantages of Having This Testing Performed

    Companies that conduct ASTM F748 Evaluation of Medical Device Biocompatibility testing demonstrate their commitment to:

    1. Product Safety

    2. Quality Management

    3. Risk Reduction

    Cost-Benefit Analysis

    The costs associated with conducting ASTM F748 Evaluation of Medical Device Biocompatibility testing are outweighed by the benefits, including:

    1. Product Safety

    2. Regulatory Compliance

    3. Competitive Advantage

    Conclusion

    ASTM F748 Evaluation of Medical Device Biocompatibility testing is a critical requirement for medical device manufacturers and other industries that require implantation as an integral part of a medical device. This laboratory test ensures the safety and efficacy of medical devices, complies with international and national standards governing biocompatibility testing, and demonstrates a commitment to quality management and risk reduction.

    Conclusion

    ASTM F748 Evaluation of Medical Device Biocompatibility testing is essential for ensuring product safety, regulatory compliance, and competitive advantage. Companies that conduct this laboratory test demonstrate their commitment to quality management and risk reduction.

    About Eurolab

    Eurolab is a leading provider of ASTM F748 Evaluation of Medical Device Biocompatibility testing services. Our experienced team of experts ensures accurate and reliable results, meeting the highest standards of quality and compliance.

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