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astm-f640-extraction-of-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 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 <87> Biological Reactivity TestsUSP <88> Tests for Plastic Materials

ASTM F640 Extraction of Medical Devices Laboratory Testing Service: A Comprehensive Guide

The ASTM F640 Extraction of Medical Devices testing service is governed by a range of international and national standards, including:

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

  • ASTM F748-13 Standard practice for selection and use of reference materials for the determination of properties of materials

  • EN 14971:2012 Medical devices Alleged risks (Alleged risk) - Part 1: Risk management

  • TSE 1429/2020 Medical devices Biological evaluation Part 1: Evaluation and testing within a risk management process

    • These standards provide the framework for the extraction of medical devices testing service, ensuring that it meets the necessary safety and regulatory requirements. The legal and regulatory framework surrounding this testing service includes:

  • European Unions Medical Device Regulation (EU) 2017/745

  • United States FDA guidelines for medical device manufacturers

  • International Organization for Standardization (ISO) standards for medical devices

    • Standard development organizations, such as ASTM International, ISO, and EN, play a crucial role in creating and updating these standards. They ensure that the testing service remains relevant and effective.

    The ASTM F640 Extraction of Medical Devices testing service is essential for ensuring the safety and efficacy of medical devices. This test is required to:

  • Evaluate the biocompatibility of medical device materials

  • Assess the risk of biological reactions associated with medical device use

  • Identify potential toxicological risks

  • Ensure compliance with regulatory requirements

    • Consequences of not performing this test include:

  • Non-compliance with regulations

  • Risk of adverse biological reactions in patients

  • Product liability and recall

  • Financial losses due to non-compliance or product failure

    • Industries that require this testing service include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Hospitals and healthcare organizations

    • This test contributes to product safety and reliability by:

  • Identifying potential risks associated with medical device use

  • Ensuring compliance with regulatory requirements

  • Providing a risk management framework for medical device development

    • The cost-benefit analysis of performing this test includes:

  • Compliance with regulations and industry standards

  • Reduced risk of adverse biological reactions

  • Improved product safety and reliability

  • Enhanced customer confidence and trust

    • The ASTM F640 Extraction of Medical Devices testing service involves the following steps:

    1. Sample preparation: Medical device samples are prepared for testing, including cleaning, cutting, and weighing.

    2. Extraction: The medical device sample is exposed to a solvent or other medium to simulate in-vivo conditions.

    3. Analysis: Extracted substances are analyzed using techniques such as gas chromatography-mass spectrometry (GC-MS) or high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).

    4. Data analysis: Results are evaluated and compared to reference materials.

    The testing equipment and instruments used include:

  • Solvent dispensers

  • Shakers and stirrers

  • GC-MS or HPLC-MS/MS systems

  • Sampling devices

    • Testing environment requirements include:

  • Temperature control (1C)

  • Humidity control (5)

  • Pressure control (0.01 bar)

    • The test report includes:

  • Sample identification and description

  • Testing conditions and methodology

  • Results, including concentrations of extracted substances

  • Conclusion and recommendations

    • Reporting standards and formats include:

  • ASTM F748-13 Standard practice for selection and use of reference materials for the determination of properties of materials

  • ISO 10012:2003 Measurement management systems Requirements for measurement processes and measuring equipment

    • Results are validated and verified using:

  • Reference materials

  • Spiking experiments

  • Repeatability and reproducibility testing

    • Electronic reporting systems used include:

  • Laboratory information management system (LIMS)

  • Quality management system (QMS)

    • Why This Test Should Be Performed

    The benefits of performing the ASTM F640 Extraction of Medical Devices testing service include:

  • Reduced risk of adverse biological reactions

  • Improved product safety and reliability

  • Compliance with regulations and industry standards

  • Enhanced customer confidence and trust

    • Quality assurance and compliance benefits include:

  • Reduced regulatory non-compliance risks

  • Improved product quality and performance

  • Enhanced market access and trade facilitation

    • Cost savings and efficiency improvements include:

  • Reduced testing timeframes

  • Increased laboratory productivity

  • Cost savings through optimized resource allocation

    • Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in this field make them an ideal partner for medical device manufacturers. Our state-of-the-art equipment, qualified personnel, and accredited facilities ensure that the ASTM F640 Extraction of Medical Devices testing service is performed to the highest standards.

    We provide:

  • Expertise in biocompatibility testing

  • State-of-the-art laboratory facilities

  • Qualified personnel with extensive experience in medical device testing

    • Our QMS ensures that all testing services meet regulatory requirements, including:

  • ISO 9001:2015 Quality management systems Requirements

  • ISO 13485:2016 Medical devices Quality management systems - Requirements for regulatory purposes

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

    CONTACT US +902127020000

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