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iso-14708-active-implantable-medical-devices
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 14708-3 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

Comprehensive Guide to ISO 14708 Active Implantable Medical Devices Laboratory Testing Service Provided by Eurolab

ISO 14708 is an international standard that specifies the requirements for laboratory testing of active implantable medical devices (AIMDs). The standard is developed and maintained by the International Electrotechnical Commission (IEC) in collaboration with other standard development organizations (SDOs).

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 14708 AIMD testing is governed by various international, national, and regional regulations. These include:

  • European Unions Medical Device Regulation (MDR)

  • US FDAs Quality System Regulation (QSR) for medical devices

  • International Organization for Standardization (ISO) standards, such as ISO 13485 (Medical Devices - Quality Management Systems Requirements for Regulatory Purposes)

  • European Commissions Medical Device Directive (MDD)

    • International and National Standards

    The following international and national standards apply to ISO 14708 AIMD testing:

  • IEC 60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)

  • IEC 60601-2-21:2010 (Medical electrical equipment - Part 2-21: particular requirements for the basic safety and essential performance of electrocardiographs)

  • ISO 10993-4:2003 (Biological evaluation of medical devices Part 4: Selection of tests for interaction with blood)

    • Standard Development Organizations

    SDOs play a crucial role in developing and maintaining standards. Key SDOs involved in the development of ISO 14708 AIMD testing include:

  • International Electrotechnical Commission (IEC)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Standard Evolution and Update

    Standards evolve over time to reflect advances in technology, changes in regulations, or emerging industry needs. The standard development process involves:

    1. Identification of requirements

    2. Drafting of the standard

    3. Review and approval by SDOs

    4. Publication and implementation

    Specific Standard Numbers and Scope

    The following are specific standard numbers related to ISO 14708 AIMD testing:

  • IEC 60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)

  • IEC 60601-2-21:2010 (Medical electrical equipment - Part 2-21: particular requirements for the basic safety and essential performance of electrocardiographs)

    • Standard Compliance Requirements

    Manufacturers must comply with relevant standards when designing, testing, and labeling AIMDs. Key compliance requirements include:

  • Conformity to IEC 60601-1:2005

  • Compliance with national regulations (e.g., MDR in Europe)

  • Implementation of a quality management system (QMS) as specified by ISO 13485

    • Industry-Specific Examples and Case Studies

    Case Study: A manufacturer of pacemakers must comply with IEC 60601-1:2005 and perform testing to ensure the device meets regulatory requirements.

    Standard-Related Information Conclusion

    ISO 14708 AIMD testing is governed by a complex set of international, national, and regional regulations. Manufacturers must adhere to relevant standards, including IEC 60601-1:2005, when designing, testing, and labeling active implantable medical devices.

    ISO 14708 AIMD testing is essential for ensuring the safety and performance of active implantable medical devices. The test is required to:

  • Verify compliance with regulatory requirements

  • Ensure device functionality and reliability

  • Reduce risks associated with device failure or malfunction

  • Enhance customer confidence in product quality

    • Consequences of Not Performing This Test

    Failure to perform ISO 14708 AIMD testing can result in:

  • Regulatory non-compliance and fines

  • Device recalls and damage to reputation

  • Increased costs due to rework, repair, or replacement

  • Patient harm or death due to device malfunction

    • Industries and Sectors Requiring This Testing

    The following industries require ISO 14708 AIMD testing:

  • Medical devices (e.g., pacemakers, implantable cardioverter-defibrillators)

  • Pharmaceutical industry (for drug-device combination products)

    • Risk Factors and Safety Implications

    Key risk factors associated with AIMDs include:

  • Device malfunction or failure

  • Infection or tissue damage

  • Electromagnetic interference (EMI) or electromagnetic compatibility (EMC) issues

    • Quality Assurance and Quality Control Aspects

    Manufacturers must implement a QMS to ensure compliance with relevant standards. Key aspects of QMS include:

  • Document control

  • Change control

  • Corrective action and preventive action (CAPA)

  • Internal audits and training programs

    • Competitive Advantages of Having This Testing Performed

    Performing ISO 14708 AIMD testing can provide competitive advantages, including:

  • Enhanced customer confidence in product quality

  • Increased market share due to compliance with regulatory requirements

  • Reduced costs associated with rework, repair, or replacement

    • Standard Requirements and Needs Conclusion

    ISO 14708 AIMD testing is essential for ensuring the safety and performance of active implantable medical devices. Manufacturers must comply with relevant standards, implement a QMS, and perform testing to ensure device functionality, reliability, and regulatory compliance.

    Next Section: Laboratory Testing Process

    The following section will describe the laboratory testing process involved in ISO 14708 AIMD testing, including:

  • Test equipment and instruments

  • Test procedures and protocols

  • Data analysis and reporting

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