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afnor-bp-x30-221-in-vivo-human-skin-testing-procedures
Dermatological & Sensitivity Testing ASTM 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 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

AFNOR BP X30-221 In Vivo Human Skin Testing Procedures Laboratory Testing Service: A Comprehensive Guide

The AFNOR BP X30-221 In Vivo Human Skin Testing Procedures laboratory testing service is governed by a range of international and national standards, including:

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

  • ASTM F739-08 Standard Test Method for Permeation of Liquids Through Protective Clothing Materials Using the Cup Method

  • EN ISO 10993-5:2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

  • TSE (Turkish Standards Institution) IEC/EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - Safety requirements

  • USP <87> and <88>: Biological reactivity tests

    • These standards provide the framework for conducting In Vivo human skin testing procedures to evaluate the safety and efficacy of medical devices, cosmetics, and other products.

    Standard Development Organizations (SDOs) and their Role

    SDOs play a crucial role in developing and maintaining standards. The main SDOs involved in the development of AFNOR BP X30-221 In Vivo Human Skin Testing Procedures testing are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Electrotechnical Standardization (CENELEC)

    • These organizations work together to develop, publish, and maintain standards that ensure consistency and quality in the testing process.

    Standard Evolution and Update

    Standards evolve over time to reflect changing technologies, regulatory requirements, and scientific knowledge. This ensures that testing procedures remain relevant and effective.

    Specific Standard Numbers and their Scope

  • ISO 10993-1:2009 provides a framework for evaluating biological hazards of medical devices.

  • ASTM F739-08 tests the permeation of liquids through protective clothing materials using the cup method.

  • EN ISO 10993-5:2014 evaluates cytotoxicity in vitro.

    • Industry-Specific Examples and Case Studies

    AFNOR BP X30-221 In Vivo Human Skin Testing Procedures testing is required for various industries, including:

  • Medical devices (e.g., implants, contact lenses)

  • Cosmetics (e.g., skincare products, sunscreens)

  • Pharmaceuticals

  • Chemicals

    • These industries rely on accurate and reliable testing to ensure product safety and efficacy.

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for various industries. Failure to comply can result in costly fines, recalls, or even business closure.

    Business and Technical Reasons for Conducting AFNOR BP X30-221 In Vivo Human Skin Testing Procedures Testing

    Conducting this testing ensures:

  • Product safety and efficacy

  • Regulatory compliance

  • Quality assurance and control

  • Customer confidence and trust

    • Risk Factors and Safety Implications

    Failure to conduct adequate testing can result in:

  • Product recalls

  • Loss of customer trust

  • Regulatory fines or penalties

  • Business closure

    • Quality Assurance and Control Aspects

    Eurolabs quality management system (QMS) ensures that all tests are performed with the utmost care, attention to detail, and adherence to relevant standards.

    Contribution to Product Safety and Reliability

    AFNOR BP X30-221 In Vivo Human Skin Testing Procedures testing provides essential data for evaluating product safety and efficacy. This information helps manufacturers make informed decisions about their products.

    Competitive Advantages of Having this Testing Performed

    By conducting this testing, companies can:

  • Differentiate themselves from competitors

  • Enhance customer confidence and trust

  • Improve product quality and reliability

  • Reduce regulatory risks

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis demonstrates that the benefits of performing AFNOR BP X30-221 In Vivo Human Skin Testing Procedures testing far outweigh the costs.

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

    1. Sample preparation

    2. Testing equipment and instruments used

    3. Testing environment requirements

    4. Measurement and analysis methods

    5. Calibration and validation procedures

    6. Quality control measures during testing

    Testing Equipment and Instruments Used

  • Skin simulator equipment (e.g., skin chamber, skin model)

  • Measuring devices (e.g., pH meter, thermometer)

    • Testing Environment Requirements

  • Temperature: 22C 2C

  • Humidity: 50 10

  • Pressure: atmospheric pressure

    • Sample Preparation Procedures

  • Skin samples preparation (e.g., excised skin, in vivo)

  • Sample labeling and identification

    • Testing Parameters and Conditions

  • Test duration: up to 24 hours

  • Temperature cycles: 4-6 cycles

  • pH range: 4.5-7.5

    • Measurement and Analysis Methods

  • Measuring device calibration

  • Data acquisition and analysis software used

  • Statistical analysis (e.g., mean, standard deviation)

    • Calibration and Validation Procedures

  • Equipment calibration

  • Testing procedure validation

    • Quality Control Measures During Testing

  • Real-time monitoring of testing conditions

  • Regular equipment maintenance

    • Interpretation of Test Results

  • Reporting of test results

  • Data interpretation and analysis

    • Test Report Format

    The test report format includes:

  • Test summary

  • Raw data

  • Statistical analysis

  • Conclusion and recommendations

    • Standard Operating Procedures (SOPs)

    Eurolabs SOPs ensure consistency and quality in the testing process. These procedures cover all aspects of testing, from sample preparation to reporting.

    Training and Certification

    All personnel involved in testing are trained and certified according to relevant standards.

    Audit Trails and Documentation

    All test data is stored securely, with audit trails maintained to track changes and modifications.

    Conclusions and Recommendations

    The AFNOR BP X30-221 In Vivo Human Skin Testing Procedures laboratory testing service provides essential data for evaluating product safety and efficacy. By following the guidelines outlined in this document, companies can ensure that their products meet regulatory requirements and are safe for use by consumers.

    Future Developments and Improvements

    Eurolab is committed to ongoing improvement and development of its testing services. This includes staying up-to-date with the latest technologies and techniques.

    By choosing Eurolab as your partner for AFNOR BP X30-221 In Vivo Human Skin Testing Procedures testing, you can be assured that your products are safe, reliable, and compliant with regulatory requirements.

    References

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

  • ASTM F739-08 Standard Test Method for Permeation of Liquids Through Protective Clothing Materials Using the Cup Method

  • EN ISO 10993-5:2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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