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iso-10993-20-dermal-toxicology-testing-methods
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 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 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 10993-20 Dermal Toxicology Testing Methods Laboratory Testing Service: A Comprehensive Guide

The ISO 10993-20 Dermal Toxicology Testing Methods standard is a widely accepted international standard for evaluating the safety of medical devices and materials on human skin. This standard provides guidelines for conducting dermal toxicity testing, which is essential for ensuring the safety and efficacy of products that come into contact with human skin.

Relevant Standards

The ISO 10993-20 standard is part of the larger ISO 10993 series, which focuses on biological evaluation of medical devices. Other relevant standards include:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • ASTM F739-17 Standard test method for permeation of liquids through protective clothing by immersion

  • EN ISO 10993-20:2006 Biological evaluation of medical devices Part 20: Assessment of dermal irritation/irritant contact dermatitis (in vitro)

  • TSE L1162:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 10993-20 Dermal Toxicology Testing Methods testing is governed by various international and national standards. These regulations ensure that medical devices and materials meet the necessary safety and efficacy criteria.

  • EU Medical Device Regulation (MDR) 2017/745

  • US FDA 21 CFR Part 801 (Medical Devices)

  • ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes

    • Standard Development Organizations

    The development of standards is a collaborative effort among standard development organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to ensure that standards are developed and updated in a timely manner.

    Standard Compliance Requirements

    Compliance with ISO 10993-20 Dermal Toxicology Testing Methods is mandatory for medical devices and materials that come into contact with human skin. This includes:

  • Medical device manufacturers

  • Material suppliers

  • Regulatory bodies

    • Failure to comply with this standard can result in severe consequences, including product recalls, fines, and reputational damage.

    Why ISO 10993-20 Dermal Toxicology Testing Methods is Needed

    The primary reason for conducting ISO 10993-20 Dermal Toxicology Testing Methods testing is to ensure the safety and efficacy of products that come into contact with human skin. This standard provides a framework for evaluating the potential risks associated with dermal exposure.

    Business and Technical Reasons for Conducting ISO 10993-20 Dermal Toxicology Testing Methods

    Conducting ISO 10993-20 Dermal Toxicology Testing Methods testing is essential for:

  • Ensuring product safety and efficacy

  • Mitigating risk and liability

  • Complying with regulatory requirements

  • Enhancing customer trust and confidence

    • Consequences of Not Performing this Test

    Failure to conduct ISO 10993-20 Dermal Toxicology Testing Methods testing can result in severe consequences, including:

  • Product recalls

  • Fines and penalties

  • Reputational damage

  • Loss of business and revenue

    • Industries and Sectors that Require this Testing

    ISO 10993-20 Dermal Toxicology Testing Methods is essential for various industries, including:

  • Medical device manufacturers

  • Material suppliers

  • Cosmetics and personal care products

  • Pharmaceuticals

    • Risk Factors and Safety Implications

    Dermatological reactions can be unpredictable and may result in severe consequences. This testing ensures that products meet the necessary safety criteria.

    Quality Assurance and Quality Control Aspects

    Conducting ISO 10993-20 Dermal Toxicology Testing Methods testing is essential for maintaining quality assurance and control. This includes:

  • Ensuring test equipment and instruments are calibrated and validated

  • Maintaining accurate records and documentation

  • Following established protocols and procedures

    • Why this Test Contributes to Product Safety and Reliability

    ISO 10993-20 Dermal Toxicology Testing Methods testing ensures that products meet the necessary safety criteria, reducing the risk of dermatological reactions.

    Competitive Advantages of Having this Testing Performed

    Conducting ISO 10993-20 Dermal Toxicology Testing Methods testing provides a competitive advantage by:

  • Enhancing customer trust and confidence

  • Demonstrating compliance with regulatory requirements

  • Mitigating risk and liability

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis of conducting ISO 10993-20 Dermal Toxicology Testing Methods testing is clear. The benefits far outweigh the costs, ensuring a safe and reliable product.

    Detailed Step-by-Step Explanation of How the Test is Conducted

    The ISO 10993-20 Dermal Toxicology Testing Methods standard provides guidelines for conducting dermal toxicity testing. This includes:

  • Pre-testing preparation

  • Test material application

  • Exposure and observation

  • Results analysis and interpretation

    • Pre-Testing Preparation

    Before conducting the test, it is essential to prepare the necessary materials and equipment.

  • Selecting suitable test material

  • Calibrating and validating test equipment

  • Preparing the testing environment

    • Test Material Application

    The test material is applied to the skin in a controlled manner.

  • Ensuring accurate application

  • Maintaining uniformity and consistency

    • Exposure and Observation

    The test material is exposed to the skin for an extended period.

  • Monitoring and recording observations

  • Documenting any adverse reactions

    • Results Analysis and Interpretation

    The results are analyzed and interpreted according to established protocols.

  • Identifying potential risks and hazards

  • Determining the necessary safety measures

    • Test Results and Reporting

    The test results are documented and reported in a clear and concise manner.

  • Providing detailed information on test procedures

  • Describing any adverse reactions or findings

    • Conclusion

    In conclusion, ISO 10993-20 Dermal Toxicology Testing Methods is an essential standard for evaluating the safety of medical devices and materials on human skin. Conducting this testing ensures that products meet the necessary safety criteria, reducing the risk of dermatological reactions.

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