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astm-e1490-evaluation-of-allergic-contact-dermatitis
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 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 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 E1490 Evaluation of Allergic Contact Dermatitis Testing Service Provided by Eurolab

The ASTM E1490 Evaluation of Allergic Contact Dermatitis testing service is governed by a set of international and national standards that ensure the accuracy, reliability, and safety of the test results. This section provides an in-depth overview of the relevant standards, legal and regulatory framework, and standard development organizations.

ASTM E1490 Standard Overview

The ASTM E1490 standard outlines the requirements for evaluating allergic contact dermatitis using a patch testing method. The standard specifies the materials, equipment, and procedures to be used for testing and provides guidelines for data interpretation and reporting.

ISO/EN/TSE Standards

The ISO (International Organization for Standardization), EN (European Committee for Standardization), and TSE (Turkish Standards Institution) standards that apply to this specific laboratory test include:

  • ISO 10993-10:2010 - Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

  • EN 14022:2003 - Skin sensitization testing in the guinea pig

  • TSE EN ISO 10993-10:2012 - Biyolojik değerlendirme (Biological Evaluation) için uyulması gereken kurallar

    • Standard Development Organizations

    The standard development organizations responsible for maintaining and updating these standards include:

  • American Society for Testing and Materials (ASTM)

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (EN)

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding ASTM E1490 Evaluation of Allergic Contact Dermatitis testing includes various national and international regulations, such as:

  • EU Cosmetics Regulation 1223/2009

  • US FDA Good Laboratory Practice Regulations

  • ISO 9001:2015 Quality Management System

    • International and National Standards

    The following table summarizes the relevant standards that apply to this specific laboratory test:

    Standard Title Scope

    --- --- ---

    ASTM E1490 Evaluation of Allergic Contact Dermatitis Patch testing method for evaluating allergic contact dermatitis

    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization Testing for irritation and skin sensitization in medical devices

    EN 14022:2003 Skin sensitization testing in the guinea pig Guinea pig skin sensitization testing

    TSE EN ISO 10993-10:2012 Biyolojik değerlendirme (Biological Evaluation) için uyulması gereken kurallar Biological evaluation requirements for medical devices

    Standard Compliance Requirements

    Compliance with these standards is essential to ensure the accuracy, reliability, and safety of the test results. Companies that require this testing must ensure that their products meet the relevant standard requirements.

    Standard-Related Information Conclusion

    In conclusion, the ASTM E1490 Evaluation of Allergic Contact Dermatitis testing service is governed by a set of international and national standards that ensure the accuracy, reliability, and safety of the test results. Understanding these standards and complying with them is essential to maintain quality, safety, and regulatory compliance.

    The ASTM E1490 Evaluation of Allergic Contact Dermatitis testing service is necessary for various industries and sectors that require evaluating allergic contact dermatitis in their products or materials. This section explains the business and technical reasons for conducting this test, the consequences of not performing it, and the benefits of having this testing performed.

    Why This Test Is Needed

    This test is essential for ensuring product safety and reliability by identifying potential allergens and irritants that may cause skin sensitization in users. The test results can help companies to:

  • Ensure compliance with regulatory requirements

  • Improve product safety and quality

  • Reduce the risk of product liability

  • Enhance customer confidence and trust

    • Consequences of Not Performing This Test

    Failing to conduct this testing may lead to:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Damage to brand reputation and customer trust

  • Increased costs due to potential lawsuits or settlements

    • Industries and Sectors That Require This Testing

    The following industries and sectors require ASTM E1490 Evaluation of Allergic Contact Dermatitis testing:

  • Cosmetics and personal care products

  • Pharmaceuticals and medical devices

  • Textiles and clothing

  • Chemicals and dyes

  • Food packaging and contact materials

    • Risk Factors and Safety Implications

    Allergic contact dermatitis can have serious safety implications, including:

  • Skin irritation and inflammation

  • Allergic reactions and sensitization

  • Potential for anaphylaxis or other life-threatening conditions

    • Quality Assurance and Quality Control Aspects

    The quality assurance and quality control aspects of this testing service include:

  • Ensuring that the test is conducted in accordance with relevant standards and guidelines

  • Verifying the accuracy, reliability, and safety of the test results

  • Implementing corrective actions to address any discrepancies or non-compliances

    • Benefits of Having This Testing Performed

    The benefits of having this testing performed include:

  • Enhanced product safety and quality

  • Improved customer confidence and trust

  • Reduced risk of regulatory non-compliance

  • Increased competitiveness in the market

    • Standard Requirements and Needs Conclusion

    In conclusion, the ASTM E1490 Evaluation of Allergic Contact Dermatitis testing service is necessary for ensuring product safety and reliability by identifying potential allergens and irritants that may cause skin sensitization in users. Understanding the standard requirements and needs is essential to maintain quality, safety, and regulatory compliance.

    Comprehensive Guide Conclusion

    In conclusion, this comprehensive guide has provided an overview of the ASTM E1490 Evaluation of Allergic Contact Dermatitis testing service, including the relevant standards, legal and regulatory framework, and standard development organizations. Understanding these aspects is essential for ensuring product safety and reliability by identifying potential allergens and irritants that may cause skin sensitization in users.

    Please note that this guide is a general overview and not intended to be a substitute for professional advice or guidance. It is recommended to consult with a qualified expert or laboratory to ensure compliance with relevant standards and guidelines.

    Appendix

    The following appendix provides additional information on the ASTM E1490 standard, including:

  • Standard overview

  • Standard requirements

  • Test procedure

  • Data interpretation and reporting

    • Please refer to the ASTM E1490 standard for more detailed information.

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