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iso-10993-13-identification-and-quantification-of-degradation-products
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 10993-14 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

Comprehensive Guide to ISO 10993-13 Identification and Quantification of Degradation Products Testing Services by Eurolab

ISO 10993-13 is a standard developed by the International Organization for Standardization (ISO) to identify and quantify degradation products in medical devices. This standard is part of the ISO 10993 series, which focuses on biological evaluation of medical devices.

The legal and regulatory framework surrounding this testing service is governed by various international and national standards. The primary standard that governs this testing service is ISO 10993-13:2016(E) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products.

This standard requires manufacturers to identify and quantify degradation products in their medical devices, which may be released during use or storage. The purpose of this testing is to ensure that the degradation products do not pose any risk to patients or users.

International standards that apply to this specific laboratory test include:

  • ISO 10993-13:2016(E) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products

  • ASTM F748-12: Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

  • EN ISO 10993-1:2009A1:2015 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Standard development organizations play a crucial role in developing and maintaining these standards. Organizations such as the International Organization for Standardization (ISO) and ASTM International are responsible for developing and updating international standards.

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, and new scientific evidence. The ISO 10993 series is updated periodically to incorporate new test methods, materials, or technologies.

    Specific standard numbers and their scope include:

  • ISO 10993-13:2016(E) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products

  • ISO 10993-1:2009A1:2015 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Standard compliance requirements for different industries include:

  • Medical device manufacturers must comply with ISO 10993-13

  • Pharmaceutical companies must comply with ASTM F748-12

  • Biotechnology companies must comply with EN ISO 10993-1

    • The ISO 10993-13 test is required to ensure that medical devices do not pose any risk to patients or users. This test is necessary because degradation products can be toxic, carcinogenic, or mutagenic.

    Business and technical reasons for conducting this test include:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements

  • Maintaining quality assurance and control

  • Reducing the risk of product recalls

  • Improving customer confidence and trust

    • Consequences of not performing this test include:

  • Product failures or malfunctions

  • Patient harm or injury

  • Regulatory non-compliance

  • Loss of market share and reputation

    • Industries that require this testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • Risk factors and safety implications associated with degradation products include:

  • Toxicity

  • Carcinogenicity

  • Mutagenicity

  • Allergenicity

  • Sensitization

    • Quality assurance and quality control aspects of the test include:

  • Calibration and validation of equipment

  • Standard operating procedures (SOPs)

  • Training and certification of personnel

  • Record-keeping and documentation

    • This test contributes to product safety and reliability by identifying and quantifying degradation products, which can be toxic or hazardous.

    Competitive advantages of having this testing performed include:

  • Enhanced product safety and reliability

  • Improved regulatory compliance

  • Increased customer confidence and trust

  • Reduced risk of product recalls

  • Market positioning and leadership

    • Cost-benefit analysis of performing this test includes:

  • Initial investment in equipment and training

  • Ongoing costs for calibration, validation, and maintenance

  • Savings from reduced product failures or malfunctions

  • Improved regulatory compliance and reduced fines

  • Enhanced customer confidence and trust

    • The ISO 10993-13 test is conducted in accordance with the standards requirements. The testing equipment and instruments used include:

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

  • Spectrophotometry

  • Chromatographic software

    • Testing environment requirements include:

  • Temperature: 20C to 30C

  • Humidity: 40 to 60

  • Pressure: 1 atm to 2 atm

    • Sample preparation procedures involve:

  • Extraction of degradation products from medical devices

  • Preparation of standard solutions for calibration and validation

  • Analysis of samples using HPLC or GC-MS

    • Analysis of samples involves:

  • Separation of degradation products using chromatography

  • Identification and quantification of degradation products using spectrophotometry

  • Calculation of degradation product concentrations

    • Conclusion

    The ISO 10993-13 test is a critical component of medical device testing, ensuring that degradation products do not pose any risk to patients or users. By understanding the standard requirements, business and technical reasons for conducting this test, and the consequences of non-compliance, manufacturers can ensure their products meet regulatory requirements and maintain quality assurance and control.

    Appendix

  • ISO 10993-13:2016(E) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products

  • ASTM F748-12: Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

  • EN ISO 10993-1:2009A1:2015 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • References

  • ISO 10993-13:2016(E) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products

  • ASTM F748-12: Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

  • EN ISO 10993-1:2009A1:2015 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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