EUROLAB
iso-24443-in-vitro-uv-protection-factor-testing-for-sunscreens
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 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 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 24443 In Vitro UV Protection Factor Testing for Sunscreens: Eurolabs Laboratory Testing Service

Overview of Relevant Standards

The ISO 24443 standard is a globally recognized testing methodology for assessing the in vitro UV protection factor (UPF) of sunscreens. This standard is developed by the International Organization for Standardization (ISO), an independent, non-governmental organization that brings together experts from over 160 countries to develop and maintain standards.

Legal and Regulatory Framework

The use of sunscreens is subject to various regulations and guidelines worldwide. In the European Union, for example, Regulation (EC) No 1223/2009 sets out requirements for the safety assessment of cosmetic products, including sunscreens. The regulation mandates that all sunscreen products must undergo rigorous testing to ensure their safety and efficacy.

International and National Standards

The ISO 24443 standard is a widely adopted international standard, but national standards may also apply depending on the country of use. For instance, in Japan, the Ministry of Health, Labour and Welfare (MHLW) has established its own standard for sunscreen testing, which is based on the ISO 24443 methodology.

Standard Development Organizations

Standard development organizations (SDOs) play a crucial role in maintaining and updating standards. In the case of ISO 24443, the SDO responsible is the International Organization for Standardization (ISO). Other prominent SDOs include ASTM International (ASTM), Deutsches Institut für Normung (DIN), and Association Française de Normalisation (AFNOR).

Evolution and Updates

Standards evolve to reflect changing technological advancements, regulatory requirements, or new scientific findings. The ISO 24443 standard has undergone several revisions since its initial publication in 2007, with the most recent update being published in 2020.

Standard Numbers and Scope

The following are some relevant standard numbers and their scope:

  • ISO 24443:2019 - In vitro testing methods for sunscreen products
  • ASTM E2531-11 (Reapproved 2018) - Standard Practice for Laboratory Testing of Sunscreen Products
  • EN 13726-2:2007 - Cosmetics Sun protection factor (SPF) Part 2: Determination of SPF in vivo by the persistent pigment darkening (PPD) method
  • Compliance Requirements

    Compliance with standards is mandatory for industries that manufacture and sell sunscreens. Failure to comply can result in legal consequences, product recalls, or damage to brand reputation.

    Business and Technical Reasons

    The ISO 24443 standard is necessary due to the increasing importance of ensuring the safety and efficacy of sunscreen products. Sunscreen testing is essential for protecting consumers from UV radiation, which can cause skin damage, premature aging, and even skin cancer.

    Consequences of Not Performing this Test

    Not performing the ISO 24443 test can lead to several consequences:

  • Failure to comply with regulatory requirements
  • Product recalls or withdrawal from the market
  • Damage to brand reputation
  • Loss of customer trust
  • Increased risk of adverse reactions or injuries
  • Industries and Sectors

    The following industries and sectors require the ISO 24443 testing service:

  • Cosmetics industry
  • Pharmaceutical industry
  • Personal care products industry
  • Health and wellness sector
  • Government regulatory agencies
  • Risk Factors and Safety Implications

    Sunscreen testing is crucial for mitigating risks associated with UV radiation exposure. The consequences of not performing this test can be severe, including increased risk of skin cancer, premature aging, and eye damage.

    Step-by-Step Explanation of the Test

    The ISO 24443 testing procedure involves several steps:

    1. Sample preparation

    2. UV radiation exposure

    3. Measurement of UPF values

    4. Calculation of SPF and PPD values

    Testing Equipment and Instruments

    The following equipment is used for the ISO 24443 test:

  • UV radiation sources (e.g., LED lamps)
  • Spectrophotometers
  • Thermocouples
  • Data acquisition systems
  • Sample holders
  • Testing Environment Requirements

    The testing environment must meet specific requirements, including temperature, humidity, and pressure control.

    Sample Preparation Procedures

    Sample preparation involves diluting sunscreen products with a solvent to create a uniform mixture.

    Testing Parameters and Conditions

    The test parameters and conditions are as follows:

  • UV radiation intensity (W/m²)
  • Exposure time
  • Temperature (C)
  • Humidity ()
  • Measurement and Analysis Methods

    The UPF values are measured using spectrophotometers, while the SPF and PPD values are calculated based on the measured data.

    Test Results Documentation

    The test results are documented in a standard format, which includes:

  • Sample identification
  • Test parameters and conditions
  • UPF, SPF, and PPD values
  • Statistical analysis of the data
  • Reporting Requirements

    Reports must be submitted to regulatory agencies, as required by local regulations.

    5. CONCLUSION

    In conclusion, the ISO 24443 standard is a globally recognized testing methodology for assessing the in vitro UV protection factor (UPF) of sunscreens. The standard requires rigorous testing procedures to ensure the safety and efficacy of sunscreen products. Eurolabs laboratory testing service adheres to this standard, providing accurate and reliable results to support compliance with regulatory requirements.

    ---

    Eurolabs ISO 24443 Laboratory Testing Service

    Contact us today to learn more about our ISO 24443 laboratory testing service:

    Insert contact information

    We look forward to supporting your sunscreen product development needs!

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

    Latest News

    View all

    JOIN US
    Want to make a difference?

    Careers