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en-iso-10993-11-systemic-toxicity
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 10993-5 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

EN ISO 10993-11 Systemic Toxicity Laboratory Testing Service: A Comprehensive Guide

EN ISO 10993-11 is a standardized test method for evaluating the systemic toxicity of medical devices, materials, and substances. The standard provides guidelines for conducting laboratory tests to assess the potential harm that these products may cause when introduced into the human body.

The European Standard EN ISO 10993-11 is based on the International Organization for Standardization (ISO) standard 10993-11:2015, which was published in collaboration with the American Society for Testing and Materials (ASTM). The standard has been adopted by various countries and is widely recognized as a benchmark for evaluating systemic toxicity.

Legal and Regulatory Framework

The legal and regulatory framework surrounding EN ISO 10993-11 testing is governed by regulations such as the European Unions Medical Device Regulation (MDR), which requires manufacturers to demonstrate conformity with this standard. In addition, several national standards have been developed to align with EN ISO 10993-11.

International and National Standards

EN ISO 10993-11 is a harmonized standard that has been adopted by various countries, including the United States, Japan, China, and Europe. The following are some of the key international and national standards related to EN ISO 10993-11:

  • ISO 10993-1:2009 (Medical devices - Part 1: Evaluation of biocompatibility)

  • ASTM F748-15 (Standard Guide for Selecting Generic Biological Test Methods for Materials and Products)

  • EU Medical Device Regulation (2017/745) Annex I, Section 13.3

  • US FDA Guidance Document Guidance on the Preparation of Biocompatibility Studies

    • Standard Development Organizations

    The standard development organizations that have contributed to EN ISO 10993-11 include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • How Standards Evolve and Get Updated

    Standards evolve and get updated through a collaborative process involving standard development organizations, industry experts, and regulatory bodies. The following are some of the key factors that contribute to updates in standards:

  • Advances in technology

  • Changes in regulations

  • New scientific findings

    • Specific Standard Numbers and Their Scope

    EN ISO 10993-11 is one of several standards within the ISO 10993 series, which provides guidelines for evaluating biocompatibility. The following are some of the key standard numbers and their scope:

    Standard Number Title

    --- ---

    EN ISO 10993-1:2009 Medical devices - Part 1: Evaluation of biocompatibility

    EN ISO 10993-11:2015 Biological evaluation of medical devices - Part 11: Systemic toxicity

    EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for in vitro cytotoxicity

    Industry-Specific Requirements and Compliance

    EN ISO 10993-11 is a widely recognized standard, but industry-specific requirements and compliance guidelines may vary. The following are some examples of industries that require this testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • In conclusion, EN ISO 10993-11 is an essential standardized test method for evaluating the systemic toxicity of medical devices, materials, and substances. Manufacturers must comply with this standard to ensure regulatory approval and market access.

    EN ISO 10993-11 is a critical test method that provides valuable insights into the potential harm caused by medical devices, materials, and substances when introduced into the human body. The following are some of the key business and technical reasons for conducting this testing:

  • Ensuring regulatory compliance: Manufacturers must demonstrate conformity with EN ISO 10993-11 to ensure regulatory approval.

  • Protecting public health: By evaluating systemic toxicity, manufacturers can identify potential risks and take corrective action to protect public health.

  • Maintaining market access: Compliance with EN ISO 10993-11 is essential for maintaining market access and avoiding costly recalls.

    • Consequences of Not Performing This Test

    The consequences of not performing EN ISO 10993-11 testing include:

  • Regulatory non-compliance

  • Market access restrictions

  • Product recalls

  • Liability claims

    • Risk Factors and Safety Implications

    EN ISO 10993-11 is a critical test method that helps manufacturers identify potential risks associated with systemic toxicity. Some of the key risk factors and safety implications include:

  • Biocompatibility: EN ISO 10993-11 assesses the biocompatibility of materials, which is essential for ensuring public health.

  • Toxicity: The standard evaluates the potential toxicity of substances, which can cause harm to humans.

    • Quality Assurance and Quality Control Aspects

    EN ISO 10993-11 requires manufacturers to implement quality assurance and quality control measures to ensure compliance with this standard. Some of the key aspects include:

  • Validated test methods

  • Calibrated equipment

  • Trained personnel

    • How EN ISO 10993-11 Testing Benefits Manufacturers

    EN ISO 10993-11 testing provides manufacturers with valuable insights into the potential harm caused by medical devices, materials, and substances. Some of the key benefits include:

  • Ensuring regulatory compliance: Manufacturers can demonstrate conformity with this standard to ensure regulatory approval.

  • Protecting public health: EN ISO 10993-11 helps manufacturers identify potential risks and take corrective action to protect public health.

  • Maintaining market access: Compliance with EN ISO 10993-11 is essential for maintaining market access and avoiding costly recalls.

    • Case Studies

    Several case studies have demonstrated the importance of EN ISO 10993-11 testing. For example, a medical device manufacturer that failed to comply with this standard faced regulatory non-compliance and product recalls.

    In conclusion, EN ISO 10993-11 is an essential standardized test method for evaluating systemic toxicity. Manufacturers must comply with this standard to ensure regulatory approval and protect public health.

    EN ISO 10993-11 Systemic Toxicity Laboratory Testing Service: A Comprehensive Guide

    The EN ISO 10993-11 laboratory testing process involves several steps:

    1. Test preparation: The test sample is prepared according to the standards requirements.

    2. Test execution: The test is executed using validated methods and calibrated equipment.

    3. Data analysis: The data is analyzed and interpreted in accordance with the standards guidelines.

    Types of Tests

    EN ISO 10993-11 includes several types of tests, including:

  • In vitro cytotoxicity assays

  • In vivo biocompatibility studies

  • Systemic toxicity assessments

    • Sample Preparation

    The sample preparation process involves several steps:

    1. Sampling: The test sample is collected and prepared according to the standards requirements.

    2. Storage: The sample is stored in a controlled environment to maintain its integrity.

    Test Execution

    The test execution process involves several steps:

    1. Instrument calibration: The equipment used for testing is calibrated according to the standards guidelines.

    2. Test method validation: The test methods are validated to ensure accuracy and reliability.

    3. Data collection: Data is collected using calibrated equipment and validated test methods.

    Data Analysis

    The data analysis process involves several steps:

    1. Data interpretation: The data is interpreted in accordance with the standards guidelines.

    2. Conclusion drawing: A conclusion is drawn based on the data analysis.

    In conclusion, EN ISO 10993-11 laboratory testing provides manufacturers with valuable insights into the potential harm caused by medical devices, materials, and substances. Manufacturers must comply with this standard to ensure regulatory approval and protect public health.

    Conclusion

    EN ISO 10993-11 is an essential standardized test method for evaluating systemic toxicity. Manufacturers must comply with this standard to ensure regulatory approval and protect public health. By understanding the importance of EN ISO 10993-11, manufacturers can take corrective action to avoid costly recalls and liability claims.

    Recommendations

    The following are some recommendations for manufacturers:

    1. Conduct regular testing: Manufacturers should conduct regular testing to ensure compliance with EN ISO 10993-11.

    2. Implement quality assurance measures: Manufacturers should implement quality assurance measures, such as validated test methods and calibrated equipment.

    3. Train personnel: Personnel involved in the testing process should be trained to ensure accuracy and reliability.

    In conclusion, EN ISO 10993-11 is a critical standardized test method for evaluating systemic toxicity. Manufacturers must comply with this standard to ensure regulatory approval and protect public health.

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