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iso-10993-35-assessment-of-extractables-and-leachables
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 10993-36 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

Comprehensive Guide to ISO 10993-35 Assessment of Extractables and Leachables Laboratory Testing Service

Provided by Eurolab: A Leading Expert in Laboratory Testing Services

ISO 10993-35 is a widely recognized standard that provides guidelines for the assessment of extractables and leachables from medical devices, materials, and components. This standard is part of the ISO 10993 series, which outlines the requirements for biological evaluation of medical devices. The ISO 10993-35 standard specifically addresses the assessment of extractables and leachables, which are substances that can be released from a material or device into a patients body.

Relevant Standards:

  • ISO 10993 (Biological evaluation of medical devices)

  • ASTM F748 (Standard Practice for Selecting Temperatures for End-Point in Extractable Testing)

  • EN 14605 (Implantable parts and assemblies of implantable parts)

  • TSE (Turkish Standards Institution) EN ISO 10993-35

  • Other relevant standards may include:

    • USP <665> (Extractables from Pharmaceutical Packaging Materials)

    USP <1660> (Leachables from Pharmaceutical Packaging Materials)

    Standard Development Organizations:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

  • Other standard development organizations may include:

    • US Pharmacopeia (USP)

    International Council on Systems Engineering (INCOSE)

    International and National Standards:

  • ISO 10993-35 is an international standard that has been adopted by various countries, including the United States, Europe, and Japan.

  • National standards that are similar to or based on ISO 10993-35 may include:

    • USP <665> (Extractables from Pharmaceutical Packaging Materials)

    EN 14605 (Implantable parts and assemblies of implantable parts)

    Standard Compliance Requirements:

  • Medical device manufacturers must comply with the relevant standards, including ISO 10993-35.

  • Regulatory agencies, such as the FDA in the United States, require medical devices to meet certain standards before they can be approved for market.

    • Standard Evolution and Updates:

  • Standards are regularly updated to reflect new technologies, materials, and testing methods.

  • Eurolab stays up-to-date with the latest standard developments and provides training and support to our customers on the latest requirements.

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    Why is ISO 10993-35 Assessment of Extractables and Leachables Testing Required?

    The assessment of extractables and leachables from medical devices, materials, and components is critical to ensure patient safety. This testing helps to identify potential hazards associated with these substances and ensures that they meet regulatory requirements.

    Business and Technical Reasons for Conducting ISO 10993-35 Assessment:

  • To comply with regulatory requirements

  • To reduce the risk of product recalls or liability claims

  • To improve product safety and reliability

  • To enhance customer confidence and trust

    • Consequences of Not Performing This Test:

  • Failure to meet regulatory requirements

  • Increased risk of product failures or malfunctions

  • Potential harm to patients

  • Loss of business reputation and revenue

    • Industries and Sectors that Require this Testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Hospitals and healthcare institutions

  • Research and development organizations

    • Risk Factors and Safety Implications:

  • Failure to identify extractables and leachables can lead to patient harm or injury

  • Inadequate testing can result in regulatory non-compliance and product recalls

  • Incomplete testing may not detect potential hazards, leading to unforeseen consequences

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    Step-by-Step Explanation of the Test:

    1. Sample preparation

    2. Testing equipment and instruments

    3. Testing environment requirements (temperature, humidity, pressure)

    4. Measurement and analysis methods

    5. Calibration and validation procedures

    6. Data collection and recording procedures

    7. Quality control measures during testing

    Testing Equipment and Instruments:

  • High-performance liquid chromatography (HPLC) or gas chromatography (GC)

  • Mass spectrometry (MS)

  • Inductively coupled plasma mass spectrometry (ICP-MS)

    • Sample Preparation Procedures:

  • Sample selection and preparation

  • Homogenization of samples

  • Extraction procedures

    • Testing Parameters and Conditions:

  • Temperature and humidity requirements

  • Pressure conditions

  • Testing timeframes and duration

    • Measurement and Analysis Methods:

  • Chromatographic analysis (HPLC, GC)

  • Mass spectrometric analysis (MS)

  • Inductively coupled plasma mass spectrometry (ICP-MS)

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    Quality Control Measures during Testing:

  • Equipment calibration and validation

  • Data quality control and validation

  • Personnel training and certification

    • Data Collection and Recording Procedures:

  • Sample labeling and tracking

  • Data entry and storage procedures

  • Reporting and documentation requirements

    • Calibration and Validation Procedures:

  • Instrument calibration and maintenance

  • Method validation and verification

  • Quality control and assurance measures

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    Compliance with Regulatory Requirements:

    Eurolab ensures that all testing is conducted in compliance with relevant regulations, including ISO 10993-35. Our team of experts provides guidance on the latest requirements and supports our customers in meeting regulatory needs.

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    Conclusion:

    The assessment of extractables and leachables from medical devices, materials, and components is a critical requirement for ensuring patient safety and regulatory compliance. Eurolab provides expert laboratory testing services to meet these requirements, ensuring that our customers products are safe and compliant with relevant standards.

    Contact us today to learn more about our ISO 10993-35 assessment of extractables and leachables laboratory testing service.

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    Persuasive Elements:

  • Use of industry-specific language and terminology

  • Emphasis on patient safety and regulatory compliance

  • Highlighting the consequences of non-compliance

  • Emphasizing the importance of expert laboratory testing services

    • Commercial Appeal:

  • Use of a clear, concise writing style

  • Incorporation of technical specifications and details

  • Inclusion of relevant standards and regulations

  • Provision of contact information for further inquiries or support

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