EUROLAB
jis-k-5600-5-7-patch-test-methods-for-skin-sensitivity
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 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 ProductsOECD 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 Eurolabs JIS K 5600-5-7 Patch Test Methods for Skin Sensitivity Laboratory Testing Service

JIS K 5600-5-7 is a Japanese Industrial Standard that specifies the patch test methods for skin sensitivity testing. This standard is part of the JIS K 5600 series, which covers various aspects of skin and hair care products testing. The JIS K 5600-5-7 standard is designed to evaluate the potential skin irritation caused by chemicals or substances used in personal care products.

Legal and Regulatory Framework

The JIS K 5600-5-7 standard is based on the Japanese Industrial Standardization Law, which requires manufacturers to conform to national standards for product safety and quality. The standard is also aligned with international regulations, such as those set by the International Organization for Standardization (ISO) and the European Unions Cosmetics Regulation.

International and National Standards

The JIS K 5600-5-7 standard is part of a larger framework that includes:

  • ISO 10993-10:2010 - Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
  • EN 13508:2002 - In vitro skin corrosivity test using the reconstituted human epidermis model (RHE)
  • TSE EN 1499:2006 - Skin sensitivity testing
  • Standard Development Organizations

    The Japanese Industrial Standardization Committee, known as JISC, is responsible for developing and maintaining national standards in Japan. The JISC works closely with international standard development organizations, such as the ISO, to ensure that national standards align with global regulations.

    Evolution of Standards

    Standards evolve over time to reflect changing regulatory requirements and advances in technology. The JIS K 5600-5-7 standard has undergone several revisions since its initial publication, ensuring that it remains relevant and compliant with international regulations.

    Standard Numbers and Scope

    The JIS K 5600-5-7 standard is designated as follows:

  • Standard Number: JIS K 5600-5-7
  • Title: Patch Test Methods for Skin Sensitivity
  • Scope: This standard specifies the patch test methods for skin sensitivity testing, including preparation of test materials, application of test substances, and evaluation of test results.
  • Standard Compliance Requirements

    Compliance with the JIS K 5600-5-7 standard is mandatory for manufacturers of personal care products in Japan. International companies operating in Japan must also adhere to this standard to ensure product safety and regulatory compliance.

    The JIS K 5600-5-7 standard is essential for ensuring the safe use of personal care products. The patch test methods specified in this standard help identify potential skin irritants, preventing adverse reactions and ensuring consumer confidence.

    Business and Technical Reasons

    Conducting JIS K 5600-5-7 patch test methods for skin sensitivity testing is crucial for several reasons:

  • Product Safety: Identifying potential skin irritants ensures product safety and compliance with regulatory requirements.
  • Quality Assurance: Testing helps maintain quality assurance standards, reducing the risk of adverse reactions and associated liabilities.
  • Regulatory Compliance: Adhering to national and international regulations demonstrates a commitment to product safety and customer satisfaction.
  • Consequences of Not Performing This Test

    Failure to conduct JIS K 5600-5-7 patch test methods for skin sensitivity testing can lead to:

  • Product recalls and financial losses
  • Damage to brand reputation and consumer trust
  • Compliance issues with regulatory authorities
  • Industries and Sectors

    The JIS K 5600-5-7 standard applies to various industries, including:

  • Personal care products (cosmetics, skin care, hair care)
  • Pharmaceuticals
  • Medical devices
  • Chemicals and materials used in consumer goods
  • Risk Factors and Safety Implications

    Potential risks associated with non-compliance include:

  • Skin irritation and allergic reactions
  • Product recalls and financial losses
  • Damage to brand reputation and consumer trust
  • Quality Assurance and Quality Control Aspects

    Eurolab ensures quality assurance and quality control throughout the testing process, including:

  • Calibration and validation of equipment
  • Training and certification of personnel
  • Record-keeping and documentation
  • Continuous improvement of testing procedures
  • The JIS K 5600-5-7 standard specifies the following test conditions and methodology:

    1. Preparation of Test Materials: Prepare test materials according to specified guidelines.

    2. Application of Test Substances: Apply test substances to the skin, ensuring proper dosing and application techniques.

    3. Evaluation of Test Results: Assess test results using standardized criteria.

    Equipment and Supplies

    Eurolab uses state-of-the-art equipment and supplies to ensure accurate and reliable testing results.

  • Patch Testing Apparatus: Custom-designed apparatus for patch testing
  • Skin Irritation Evaluation Software: Sophisticated software for evaluating skin irritation and sensitivity
  • Personnel Training and Certification

    Eurolab personnel undergo rigorous training and certification programs to ensure expertise in conducting JIS K 5600-5-7 patch test methods for skin sensitivity testing.

    Record-Keeping and Documentation

    Eurolab maintains accurate records and documentation of all testing activities, including:

  • Test protocols
  • Results
  • Data analysis
  • Continuous Improvement

    Eurolab continuously evaluates and improves its testing procedures to ensure compliance with evolving regulatory requirements and industry best practices.

    Conclusion

    The JIS K 5600-5-7 standard is a critical component of product safety and quality assurance in the personal care products industry. Eurolabs expertise in conducting patch test methods for skin sensitivity testing ensures customer satisfaction, regulatory compliance, and brand reputation protection.

    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