EUROLAB
iso-10993-16-toxicokinetic-testing-of-substances-in-dermal-exposure
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

Comprehensive Guide to ISO 10993-16 Toxicokinetic Testing of Substances in Dermal Exposure Laboratory Testing Service Provided by Eurolab

Standard-Related Information

ISO 10993-16 is a standard that outlines the requirements for toxicokinetic testing of substances in dermal exposure. This standard is part of the larger ISO 10993 series, which deals with biological evaluation of medical devices. The standard is intended to provide guidance on the assessment of the potential toxicity of substances released from medical devices during dermal contact.

The relevant standards that govern ISO 10993-16 testing include:

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

  • ISO 10993-11:2006: Biological evaluation of medical devices - Part 11: Tests for irritation and skin sensitization

  • ASTM F720-14: Standard Guide for Determining the Toxicokinetics of Chemicals in Medical Devices

    • The legal and regulatory framework surrounding this testing service includes:

  • The European Unions Medical Device Regulation (MDR)

  • The United States Food and Drug Administrations (FDA) Guidance on Biological Evaluation of Medical Devices

  • The International Organization for Standardizations (ISO) Quality Management System (QMS)

    • International standards that apply to this specific laboratory test include:

  • ISO 17025:2005 General requirements for the competence of testing and calibration laboratories

  • ISO 15189:2012 Medical laboratories - Requirements for quality and competence

    • Standard development organizations involved in the development of ISO 10993-16 testing include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Standards evolve and get updated as new research emerges, regulatory requirements change, or industry practices shift. For example, ISO 10993-1:2009 has been replaced by ISO 10993-1:2018.

    Standard Requirements and Needs

    ISO 10993-16 testing is required to ensure the safety of medical devices that come into contact with the skin. The test assesses the potential toxicity of substances released from these devices during dermal contact.

    Business and technical reasons for conducting ISO 10993-16 testing include:

  • Ensuring compliance with regulatory requirements

  • Protecting patients from adverse reactions or injuries caused by medical devices

  • Mitigating liability risks associated with product failures

    • Consequences of not performing this test include:

  • Non-compliance with regulations, resulting in fines or penalties

  • Patient harm or injury due to toxic substances released from medical devices

  • Reputation damage and loss of customer trust

    • Industries that require ISO 10993-16 testing include:

  • Medical device manufacturers

  • Regulatory agencies

  • Quality management organizations

    • Risk factors associated with this testing service include:

  • Potential exposure to hazardous chemicals during testing

  • Requirements for specialized equipment and expertise

    • Quality assurance and quality control aspects include:

  • Standard operating procedures (SOPs) for testing and reporting

  • Calibration and validation of equipment used in testing

  • Training and certification of personnel performing the test

    • Test Conditions and Methodology

    ISO 10993-16 testing is conducted according to a standard protocol that includes:

    1. Sample preparation: Preparation of test samples, including skin tissue or synthetic skin substitutes.

    2. Testing parameters: Determination of optimal testing conditions, such as temperature, humidity, and pressure.

    3. Measurement and analysis methods: Use of specialized equipment, such as spectroscopy or chromatography, to measure the release of substances from medical devices.

    4. Calibration and validation: Regular calibration and validation of equipment used in testing to ensure accuracy and reliability.

    Test Reporting and Documentation

    Test results are documented and reported according to a standardized format that includes:

    1. Test report: A detailed document outlining test conditions, parameters, and results.

    2. Interpretation of results: An explanation of the significance of test results and recommendations for further action.

    3. Certification and accreditation: Evidence of laboratory certification and accreditation.

    4. Traceability and documentation: Records of testing and reporting procedures.

    Why this Test Should be Performed

    Performing ISO 10993-16 testing provides numerous benefits, including:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance with regulatory requirements

  • Competitive advantages in the market through demonstration of product safety and reliability

  • Cost savings through reduced liability risks and minimized product failures

    • Why Eurolab Should Provide this Service

    Eurolab is uniquely qualified to provide ISO 10993-16 testing services due to:

  • Expertise and experience in toxicokinetic testing

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • International recognition and accreditation

    • Conclusion

    ISO 10993-16 testing is a critical component of ensuring the safety of medical devices that come into contact with the skin. By performing this test, manufacturers can mitigate liability risks, ensure compliance with regulatory requirements, and demonstrate product safety and reliability to customers.

    Eurolabs expertise and qualifications make us an ideal partner for organizations seeking to conduct ISO 10993-16 testing services.

    References

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

  • ASTM F720-14 Standard Guide for Determining the Toxicokinetics of Chemicals in Medical Devices

  • European Unions Medical Device Regulation (MDR)

  • United States Food and Drug Administrations (FDA) Guidance on Biological Evaluation of Medical Devices

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