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astm-e2753-human-repeat-insult-patch-test-hript
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 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 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 ASTM E2753 Human Repeat Insult Patch Test (HRIPT) Laboratory Testing Service

Standard-Related Information

The ASTM E2753 Human Repeat Insult Patch Test (HRIPT) is a laboratory testing service that evaluates the skin irritation potential of chemicals and materials. This test is governed by international and national standards, including:

  • ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation

  • ASTM E2726: Standard Practice for Human Repeat Insult Patch Test (HRIPT)

  • EN 1499:2010A1:2018 (CEN): Safety of machinery - Ergonomic requirements for the design of displays and control actuators

  • TSE ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation

    • These standards dictate the requirements for HRIPT testing, including test conditions, methodology, and reporting. Standard development organizations, such as ASTM and ISO, play a crucial role in ensuring that laboratory tests are conducted according to established guidelines.

    Standard Requirements and Needs

    The HRIPT is an essential test for companies developing chemicals and materials that come into contact with human skin. This testing service provides critical information about the potential risks associated with these substances, enabling manufacturers to take corrective action and ensure compliance with regulatory requirements.

    Conducting HRIPT testing:

  • Ensures product safety and reliability

  • Prevents costly recalls and reputational damage

  • Complies with regulatory requirements and industry standards

  • Enhances customer confidence and trust

  • Supports innovation and research development

    • Test Conditions and Methodology

    The HRIPT is a standardized test that involves applying patches of the substance to be tested to human subjects. The test consists of two phases:

    1. First Insult Phase: Patches are applied to the skin for 24 hours, after which they are removed.

    2. Repeat Insult Phase: A second set of patches is applied to the same sites 48-72 hours later.

    The testing equipment and instruments used include:

  • Patch application devices

  • Measuring tape

  • Camera

    • Testing environment requirements:

  • Temperature: 22 3C

  • Humidity: 60 10

  • Pressure: Atmospheric pressure

    • Sample preparation procedures involve:

  • Cleaning the skin sites before patch application

  • Applying a small amount of test substance to each patch

    • Test Reporting and Documentation

    HRIPT test results are documented in a detailed report, which includes:

  • Test conditions and methodology

  • Test results and data analysis

  • Conclusion and recommendations

    • Reports are typically structured according to standard reporting formats, such as ISO 10993-10. The report format and structure ensure that all necessary information is provided for regulatory submission and compliance purposes.

    Why This Test Should Be Performed

    Performing HRIPT testing provides numerous benefits, including:

  • Risk Assessment and Mitigation: Identifying potential risks associated with chemicals and materials

  • Quality Assurance and Compliance: Ensuring product safety and reliability

  • Competitive Advantages: Differentiating products through demonstration of compliance with regulatory requirements

  • Cost Savings and Efficiency Improvements: Preventing costly recalls and reputational damage

  • Legal and Regulatory Compliance Benefits: Meeting regulatory requirements and industry standards

    • Why Eurolab Should Provide This Service

    Eurolab is an expert laboratory testing service provider that offers a comprehensive range of testing services, including HRIPT. Our team:

  • Possesses extensive knowledge and experience in HRIPT testing

  • Uses state-of-the-art equipment and facilities

  • Has qualified and certified personnel

  • Is accredited and certified according to international standards

    • Our commitment to quality and customer satisfaction ensures that our clients receive accurate and reliable test results.

    Conclusion

    The ASTM E2753 Human Repeat Insult Patch Test (HRIPT) is an essential laboratory testing service for companies developing chemicals and materials that come into contact with human skin. This comprehensive guide has provided detailed information about the standard-related requirements, testing conditions and methodology, and reporting and documentation aspects of HRIPT testing.

    By conducting HRIPT testing, manufacturers can ensure product safety and reliability, prevent costly recalls and reputational damage, and comply with regulatory requirements and industry standards. Eurolab is an expert laboratory testing service provider that offers a comprehensive range of testing services, including HRIPT. Our team is committed to providing accurate and reliable test results, ensuring customer satisfaction and compliance with regulatory requirements.

    Table 1: Standard Requirements for HRIPT Testing

    Standard Title Scope

    --- --- ---

    ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation Evaluates the skin irritation potential of medical devices

    ASTM E2726 Standard Practice for Human Repeat Insult Patch Test (HRIPT) Describes the requirements for HRIPT testing

    EN 1499:2010A1:2018 (CEN) Safety of machinery - Ergonomic requirements for the design of displays and control actuators Requires manufacturers to conduct ergonomic assessments, including HRIPT testing

    Table 2: Testing Conditions and Methodology

    Parameter Value

    --- ---

    Temperature 22 3C

    Humidity 60 10

    Pressure Atmospheric pressure

    Patch application time 24 hours (first insult phase)

    Repeat insult phase 48-72 hours

    Table 3: Test Reporting and Documentation

    Parameter Value

    --- ---

    Report format ISO 10993-10

    Report structure Test conditions, methodology, results, data analysis, conclusion, recommendations

    Data analysis Statistical analysis of test results to determine skin irritation potential

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