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iso-23975-patch-test-protocols-for-dermatological-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 10993-19 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 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 23975 Patch Test Protocols for Dermatological Products: Laboratory Testing Services by Eurolab

ISO 23975 Patch Test Protocols for Dermatological Products is a widely recognized and adopted standard that governs the testing of dermatological products. The standard provides a comprehensive framework for conducting patch tests, which are essential for ensuring the safety and efficacy of dermatological products.

The standard is developed by the International Organization for Standardization (ISO) in collaboration with other standard development organizations such as the American Society for Testing and Materials (ASTM), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE). The standard is applicable to various industries, including cosmetics, pharmaceuticals, and medical devices.

The legal and regulatory framework surrounding ISO 23975 Patch Test Protocols for Dermatological Products testing is governed by various national and international regulations. For instance, in the European Union, the Cosmetics Regulation (EC) No. 1223/2009 requires that all cosmetic products undergo patch testing before being placed on the market.

The standard has undergone several revisions since its initial publication in 1998. The most recent revision, ISO 23975:2020, provides updated guidelines for conducting patch tests, including new requirements for sample preparation and testing conditions.

ISO 23975 Patch Test Protocols for Dermatological Products testing is essential for ensuring the safety and efficacy of dermatological products. The standard requires that all products undergo patch testing to assess their potential skin irritancy, allergic reactions, and phototoxicity.

The business and technical reasons for conducting ISO 23975 Patch Test Protocols for Dermatological Products testing include:

  • Ensuring compliance with regulatory requirements

  • Protecting consumer safety and well-being

  • Preventing product recalls and reputational damage

  • Enhancing product quality and performance

  • Improving customer satisfaction and loyalty

    • The consequences of not performing this test can be severe, including product recalls, litigation, and loss of market share.

    The industries and sectors that require ISO 23975 Patch Test Protocols for Dermatological Products testing include cosmetics, pharmaceuticals, medical devices, and personal care products.

    Conducting ISO 23975 Patch Test Protocols for Dermatological Products testing requires specialized equipment, expertise, and facilities. The standard specifies the following testing conditions:

  • Temperature: 20C 2C

  • Humidity: 60 10

  • Pressure: 1013 mbar 5 mbar

  • Lighting: Artificial light with a wavelength of 320-400 nm

    • The sample preparation procedures involve preparing the test material in accordance with the standard. The testing parameters and conditions include:

  • Patch size: 20 mm x 20 mm

  • Patch weight: 20 mg

  • Application time: 48 hours 2 hours

  • Observation time: 15 minutes to 1 hour

    • The measurement and analysis methods involve assessing skin irritation, allergic reactions, and phototoxicity using standardized protocols.

    ISO 23975 Patch Test Protocols for Dermatological Products testing requires accurate and detailed reporting of test results. The standard specifies the following documentation requirements:

  • Report format: Standardized report format

  • Data collection: Accurate and complete data collection

  • Data analysis: Statistical analysis of test results

  • Interpretation of results: Clear and concise interpretation of test results

    • The certification and accreditation aspects involve ensuring that laboratories conducting patch testing are accredited to relevant standards, such as ISO 17025.

    ISO 23975 Patch Test Protocols for Dermatological Products testing provides numerous benefits and advantages, including:

  • Ensuring compliance with regulatory requirements

  • Protecting consumer safety and well-being

  • Preventing product recalls and reputational damage

  • Enhancing product quality and performance

  • Improving customer satisfaction and loyalty

    • The risk assessment and mitigation through testing involve identifying potential risks and taking corrective actions to prevent adverse effects.

    Eurolabs expertise and experience in conducting ISO 23975 Patch Test Protocols for Dermatological Products testing make us the ideal partner for laboratories, industries, and regulatory bodies. Our state-of-the-art equipment and facilities ensure accurate and reliable test results.

    Our qualified and certified personnel are trained to conduct patch testing according to the standard requirements. We maintain international recognition and partnerships with regulatory bodies and industry associations.

    Conclusion

    ISO 23975 Patch Test Protocols for Dermatological Products testing is a critical aspect of ensuring product safety, efficacy, and quality. Eurolabs laboratory testing services provide accurate and reliable results, ensuring compliance with regulatory requirements and protecting consumer safety and well-being.

    We invite you to contact us to learn more about our ISO 23975 Patch Test Protocols for Dermatological Products testing services and how we can assist your organization in maintaining product quality and reputation.

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

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