EUROLAB
iso-10993-19-evaluation-of-allergic-contact-dermatitis-in-skin-products
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 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal 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

ISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin Products Laboratory Testing Service Provided by Eurolab

Standard-Related Information

The ISO 10993-19 standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices. Specifically, ISO 10993-19 outlines the requirements for evaluating allergic contact dermatitis (ACD) in skin products. This standard is essential for ensuring the safety and efficacy of medical devices that come into direct contact with human skin.

International and National Standards

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

  • ISO 10993-19:2015 (Biological evaluation of medical devices -- Part 19: Assessment of dermal irritation or corrosion)

  • EN ISO 10993-19:2014 (Biological evaluation of medical devices -- Part 19: Assessment of dermal irritation or corrosion)

  • ASTM F720-10 (Standard Test Method for Evaluation of Skin Irritation)

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and maintaining the ISO 10993 series. The European Committee for Standardization (CEN) develops EN standards, which are equivalent to ISO standards.

    Evolution of Standards

    Standards evolve as new research and technologies emerge. Updates to the standard may include changes in testing methods, sample sizes, or acceptance criteria. Manufacturers must stay informed about updates to ensure compliance.

    Compliance Requirements

    Manufacturers must comply with relevant standards for their specific products. This includes:

  • Medical devices that come into direct contact with human skin

  • Cosmetics and personal care products

  • Skin care products

    • Eurolab, as a leading laboratory testing service provider, ensures compliance with the latest international and national standards.

    Why this Test is Needed

    The ISO 10993-19 test is necessary to ensure that medical devices and skin products do not cause allergic contact dermatitis. This test helps manufacturers identify potential issues before releasing their products to market.

    Consequences of Not Performing this Test

    Failure to perform the ISO 10993-19 test can lead to:

  • Product recalls

  • Regulatory non-compliance

  • Financial losses due to product liability claims

    • Industries and Sectors Requiring this Testing

    The following industries require the ISO 10993-19 testing service:

  • Medical device manufacturers

  • Cosmetic and personal care companies

  • Skin care product manufacturers

    • Risk Factors and Safety Implications

    The risk of allergic contact dermatitis is significant, especially for products that come into direct contact with human skin. Manufacturers must take proactive measures to ensure their products are safe for use.

    Quality Assurance and Quality Control Aspects

    Eurolab ensures quality assurance and quality control through:

  • ISO/IEC 17025:2017 accreditation

  • Regular calibration and validation of equipment

  • Strict sample handling and storage procedures

    • How this Test Contributes to Product Safety and Reliability

    The ISO 10993-19 test helps manufacturers ensure their products are safe for use, reducing the risk of product liability claims.

    Competitive Advantages of Having this Testing Performed

    Manufacturers who perform the ISO 10993-19 test enjoy:

  • Improved product safety and reliability

  • Enhanced regulatory compliance

  • Competitive advantage in the market

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis of performing the ISO 10993-19 test is clear:

  • Reduced risk of product liability claims

  • Improved brand reputation

  • Compliance with regulations

    • Test Conditions and Methodology

    The ISO 10993-19 test involves a series of procedures to evaluate allergic contact dermatitis in skin products.

    1. Sample Preparation: Samples are prepared according to the standards requirements.

    2. Testing Equipment and Instruments: Specialized equipment, such as skin irritation testing devices, is used for this test.

    3. Testing Environment: The testing environment must be controlled, with precise temperature, humidity, and pressure conditions.

    4. Measurement and Analysis Methods: Results are analyzed using specialized software.

    Test Reporting and Documentation

    The ISO 10993-19 test report includes:

  • Test results

  • Interpretation of results

  • Recommendations for future improvements

    • Eurolab provides a comprehensive test report, ensuring that manufacturers can make informed decisions about their products.

    Why this Test Should be Performed

    The benefits of performing the ISO 10993-19 test are numerous:

  • Improved product safety and reliability

  • Enhanced regulatory compliance

  • Competitive advantage in the market

    • Why Eurolab Should Provide this Service

    Eurolabs expertise, state-of-the-art equipment, and qualified personnel make us an ideal choice for the ISO 10993-19 testing service.

    We provide a comprehensive testing experience, ensuring that our clients products meet the highest safety standards.

    Conclusion

    In conclusion, the ISO 10993-19 test is essential for manufacturers who produce medical devices or skin care products. Eurolabs expertise and state-of-the-art equipment make us an ideal choice for this testing service.

    Our comprehensive testing experience ensures that your products meet the highest safety standards, giving you a competitive advantage in the market.

    References

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

  • ISO 10993-19:2015 (Biological evaluation of medical devices -- Part 19: Assessment of dermal irritation or corrosion)

  • EN ISO 10993-19:2014 (Biological evaluation of medical devices -- Part 19: Assessment of dermal irritation or corrosion)

  • ASTM F720-10 (Standard Test Method for Evaluation of Skin Irritation)

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