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iso-10993-17-establishing-allowable-limits
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 10993-18 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

ISO 10993-17 Establishing Allowable Limits Laboratory Testing Service Provided by Eurolab

ISO 10993-17 is a standard that outlines the requirements for establishing allowable limits for biological evaluations of medical devices. The standard is part of the ISO 10993 series, which provides guidelines for the evaluation of biocompatibility of medical devices.

Legal and Regulatory Framework

The ISO 10993-17 standard is governed by international standards such as ISO 13485 (Medical devices - Quality management systems) and ISO 14971 (Medical devices - Application of risk management to medical devices). The standard also references national standards such as EN ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation of biological properties in vitro) and TSE ISO 10993-17 (Biological evaluation of medical devices - Part 17: Establishment of allowable limits for biological evaluations).

International and National Standards

The following international standards are relevant to the ISO 10993-17 standard:

  • ISO 13485:2016 (Medical devices - Quality management systems)

  • ISO 14971:2007 (Medical devices - Application of risk management to medical devices)

  • EN ISO 10993-1:2015 (Biological evaluation of medical devices - Part 1: Evaluation of biological properties in vitro)

  • TSE ISO 10993-17:2020 (Biological evaluation of medical devices - Part 17: Establishment of allowable limits for biological evaluations)

    • Standard Development Organizations

    The standard development organizations responsible for the development and maintenance of the ISO 10993-17 standard are:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. The ISO 10993-17 standard is updated periodically to ensure it remains relevant and effective.

    Standard Numbers and Scope

    The following are the standard numbers and their scope:

  • ISO 10993-1:2015 - Biological evaluation of medical devices - Part 1: Evaluation of biological properties in vitro

  • ISO 10993-17:2020 - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for biological evaluations

    • Standard Compliance Requirements

    Medical device manufacturers must comply with the requirements outlined in the ISO 10993-17 standard to ensure their products meet regulatory requirements.

    The ISO 10993-17 standard is essential for medical device manufacturers to establish allowable limits for biological evaluations. The following are some of the reasons why this test is required:

  • Business and Technical Reasons: Establishing allowable limits helps ensure that medical devices meet regulatory requirements, reducing the risk of product recalls and regulatory non-compliance.

  • Consequences of Not Performing This Test: Failure to perform biological evaluations can lead to product failures, injuries, or even fatalities.

  • Industries and Sectors: Medical device manufacturers in various industries, including orthopedics, cardiology, and neurology, require this testing.

  • Risk Factors and Safety Implications: Biological evaluations help identify potential risks associated with medical devices, ensuring patient safety.

    • Quality Assurance and Quality Control

    The ISO 10993-17 standard emphasizes the importance of quality assurance and control in establishing allowable limits for biological evaluations. This includes:

  • Establishing a Quality Management System (QMS): Medical device manufacturers must implement a QMS to ensure consistent production and testing.

  • Conducting Regular Audits: Regular audits help identify areas for improvement, ensuring that the QMS is effective.

    • The ISO 10993-17 standard outlines specific test conditions and methodology for establishing allowable limits for biological evaluations. The following are some of the key aspects:

  • Testing Equipment and Instruments: Specific equipment and instruments are required for conducting biological evaluations, including cell culture chambers and microscopes.

  • Testing Environment Requirements: Biological evaluations must be conducted in a controlled environment with specific temperature, humidity, and pressure conditions.

  • Sample Preparation Procedures: Samples must be prepared according to specific protocols to ensure accurate results.

    • The ISO 10993-17 standard emphasizes the importance of test reporting and documentation. The following are some of the key aspects:

  • Report Format and Structure: Test reports must follow a specific format and structure, including sections for introduction, methodology, results, and conclusions.

  • Interpretation of Test Results: Test results must be interpreted according to specific guidelines, taking into account factors such as sample size and statistical analysis.

    • Establishing allowable limits for biological evaluations is essential for medical device manufacturers. The following are some of the benefits:

  • Ensuring Regulatory Compliance: Biological evaluations help ensure that medical devices meet regulatory requirements, reducing the risk of product recalls and regulatory non-compliance.

  • Identifying Potential Risks: Biological evaluations help identify potential risks associated with medical devices, ensuring patient safety.

    • Why Choose Eurolab?

    Eurolab is a leading provider of laboratory testing services, including biological evaluations. Our team of experts has extensive experience in conducting ISO 10993-17 compliant tests and providing high-quality results.

    We offer a range of benefits, including:

  • Compliance with Regulatory Requirements: Our testing services are designed to ensure compliance with regulatory requirements, reducing the risk of product recalls and regulatory non-compliance.

  • High-Quality Results: Our team of experts uses state-of-the-art equipment and follows strict protocols to ensure high-quality results.

    • Conclusion

    Establishing allowable limits for biological evaluations is essential for medical device manufacturers. By following the ISO 10993-17 standard, manufacturers can ensure that their products meet regulatory requirements, reducing the risk of product recalls and regulatory non-compliance. Eurolab offers a range of testing services, including biological evaluations, to help manufacturers ensure compliance with regulatory requirements.

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