EUROLAB
en-iso-10993-10-sensitization-testing
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 10993-11 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

EN ISO 10993-10 Sensitization Testing: Eurolabs Laboratory Testing Service

EN ISO 10993-10 Sensitization Testing is a laboratory testing service provided by Eurolab, which adheres to the international standard EN ISO 10993-10. This standard specifies the requirements for sensitization testing of medical devices, including implantable, surgical, and non-implantable devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding EN ISO 10993-10 Sensitization Testing is governed by various standards, including:

  • EN ISO 10993-1:2014 Medical devices - Part 1: Evaluation of biological hazards

  • EN ISO 10993-2:2017 Medical devices - Part 2: Biological evaluation under the guidance of a physician for temporary or permanent contact only materials

  • EN ISO 10993-10:2005A1:2008 Medical devices - Part 10: Tests for irritation and skin sensitization

    • These standards provide a framework for medical device manufacturers to ensure that their products meet safety requirements.

    International and National Standards

    The international standard EN ISO 10993-10 is published by the International Organization for Standardization (ISO). The European Committee for Standardization (CEN) also publishes the European standard EN 12444, which is based on the ISO standard.

    National standards, such as ASTM F748 in the United States and TSE EN ISO 10993-10 in Turkey, may also be applicable. These standards specify requirements for sensitization testing of medical devices.

    Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing international standards. The European Committee for Standardization (CEN) publishes European standards based on ISO standards. National standard development organizations, such as ASTM in the United States, also develop and publish national standards.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulatory requirements, and industry practices. New editions of standards may introduce new requirements or modify existing ones.

    The EN ISO 10993-10 standard has undergone several revisions since its first publication in 2005. The current edition (2017) includes updates to the testing methodology and requirements for sensitization testing.

    Standard Numbers and Scope

    The relevant standard numbers and their scope are:

  • EN ISO 10993-1:2014 - Evaluation of biological hazards

    • Scope: This part of ISO 10993 specifies a framework for the evaluation of biological hazards associated with medical devices.

  • EN ISO 10993-2:2017 - Biological evaluation under the guidance of a physician for temporary or permanent contact only materials

    • Scope: This part of ISO 10993 provides guidelines for the evaluation of biological hazards associated with temporary or permanent contact-only materials.

  • EN ISO 10993-10:2005A1:2008 - Tests for irritation and skin sensitization

    • Scope: This part of ISO 10993 specifies requirements for testing medical devices for irritation and skin sensitization.

    Compliance Requirements

    Medical device manufacturers must comply with the relevant standards and regulations governing EN ISO 10993-10 Sensitization Testing. Compliance requires:

  • Documentation of biological evaluation, including sensitization testing

  • Labeling of products to indicate compliance with standards

  • Maintenance of records for testing and evaluation

    • Please let me know if you would like me to continue with the rest of the article.

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers