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iso-14708-3-active-implantable-device-testing
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 14708-4 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 14708-3 Active Implantable Device Testing Laboratory Testing Services Provided by Eurolab

ISO 14708-3 Active Implantable Device Testing is a comprehensive standard that outlines the requirements for testing active implantable medical devices, including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. This standard is developed by the International Organization for Standardization (ISO) and is widely adopted across the globe.

International Standards

  • ISO 14708-3:2014 - Active implantable medical devices - Part 3: Implantable neurostimulators

  • ASTM F1156-10 - Standard Specification for Testing Implantable Cardioverter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT) Devices

  • EN ISO 14708-3:2014 - Active implantable medical devices - Part 3: Implantable neurostimulators

  • TSE ISO 14708-3:2014 - Active implantable medical devices - Part 3: Implantable neurostimulators

    • National Standards

  • US FDA Guidance for Industry and Food and Drug Administration Staff - Classification of Medical Devices as Class I, IIa, IIb, or III Device (1997)

  • EU MDR 2017/745 - Regulation on the safety and performance of medical devices

  • China GB/T 17592.3-2016 - Active implantable medical devices - Part 3: Implantable neurostimulators

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing international standards, including ISO 14708-3. Other standard development organizations involved in the development of this standard include:

  • ASTM International (American Society for Testing and Materials)

  • EN ISO Technical Committee TC215

  • TSE Technical Committee TC213

    • Evolution of Standards

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, or updates to existing standards. The development process involves a collaborative effort between experts from industry, academia, and government.

    Standard Compliance Requirements

    Compliance with ISO 14708-3 is mandatory for manufacturers of active implantable medical devices seeking to enter the European market. Regulatory bodies worldwide require compliance with this standard as part of their certification processes.

    ISO 14708-3 Active Implantable Device Testing is necessary to ensure that these critical medical devices function safely and effectively within the human body. This testing service verifies the performance, safety, and reliability of implantable neurostimulators.

    Business and Technical Reasons for Conducting ISO 14708-3 Testing

    Conducting ISO 14708-3 testing is essential for manufacturers to:

  • Ensure compliance with regulatory requirements

  • Validate device performance and functionality

  • Reduce risk of adverse events and product recalls

  • Enhance customer confidence and trust

    • Consequences of Not Performing This Test

    Failure to conduct ISO 14708-3 testing can result in:

  • Non-compliance with regulatory requirements

  • Device failure or malfunction leading to patient harm

  • Loss of market share and reputation

  • Financial penalties and litigation costs

    • Industries and Sectors Requiring This Testing

    The following industries require ISO 14708-3 Active Implantable Device Testing:

  • Medical device manufacturers

  • Regulatory bodies

  • Healthcare providers

  • Insurance companies

  • Government agencies

    • Risk Factors and Safety Implications

    Active implantable medical devices pose significant risks to patients, including adverse events such as device malfunction or migration. This testing service helps mitigate these risks by ensuring device safety and performance.

    Quality Assurance and Quality Control Aspects

    ISO 14708-3 Active Implantable Device Testing involves rigorous quality control measures to ensure accurate results:

  • Use of calibrated equipment and software

  • Experienced personnel trained in test procedures

  • Regular calibration and maintenance of testing equipment

  • Adherence to Good Laboratory Practice (GLP) guidelines

    • Contribution to Product Safety and Reliability

    ISO 14708-3 Active Implantable Device Testing plays a crucial role in ensuring product safety and reliability:

  • Validation of device performance and functionality

  • Identification of potential failure modes

  • Reduction of risk of adverse events and product recalls

    • Competitive Advantages of Having This Testing Performed

    Manufacturers that conduct ISO 14708-3 testing demonstrate their commitment to quality, safety, and customer satisfaction:

  • Enhanced market positioning and reputation

  • Increased customer confidence and trust

  • Improved competitiveness in the market

    • Cost-Benefit Analysis of Performing This Test

    Conducting ISO 14708-3 testing offers significant benefits compared to costs:

  • Reduced risk of adverse events and product recalls

  • Improved quality and safety of devices

  • Enhanced regulatory compliance and market access

  • Cost savings through reduced warranty claims and litigation costs

    • ISO 14708-3 Active Implantable Device Testing involves a range of testing procedures to evaluate device performance, functionality, and safety:

  • Electrical performance tests

  • Magnetic field tests

  • Radiofrequency (RF) exposure tests

  • Electromagnetic compatibility (EMC) tests

  • Biocompatibility tests

    • Testing Equipment

    The following equipment is used for ISO 14708-3 Active Implantable Device Testing:

  • High-frequency test generators and analyzers

  • Signal generators and signal analyzers

  • Spectrum analyzers

  • Data acquisition systems

    • Test Procedures

    Each testing procedure involves a series of steps, including:

  • Preparation and setup of the device and equipment

  • Performance of the actual test

  • Evaluation and interpretation of results

  • Documentation and reporting of findings

    • Documentation and Reporting

    Results from ISO 14708-3 Active Implantable Device Testing must be documented and reported accurately:

  • Use of standardized templates and formats

  • Inclusion of all relevant data, including test parameters and results

  • Adherence to Good Laboratory Practice (GLP) guidelines

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