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iso-17516-microbiological-limits-for-skin-products
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 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

ISO 17516 Microbiological Limits for Skin Products Laboratory Testing Service: A Comprehensive Guide

ISO 17516 is a widely recognized international standard that specifies microbiological limits for skin products. This standard is designed to ensure the safety and quality of skin care products by setting guidelines for microbial contamination levels.

The legal and regulatory framework surrounding ISO 17516 testing is governed by various international and national standards, including:

  • ISO 17516:2018 Microbiological limits for skin products

  • ASTM E1174-15 Standard Guide for Sampling and Testing for Microbiological Contamination of Skin Care Products

  • EN 13726:2006A1:2015 Microbiological limits for cosmetics and personal care products

  • TSE (Turkish Standards Institution) TS 1093 Microbiological Limits for Cosmetics

    • These standards are developed by organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TSE).

    Standard development organizations play a crucial role in creating and maintaining standards. They bring together experts from various industries to develop and update standards, ensuring they remain relevant and effective.

    Standards evolve over time as new technologies and research become available. Updates are made to reflect changes in industry practices, regulatory requirements, and scientific knowledge.

    Some key standard numbers related to ISO 17516 testing include:

  • ISO 17516:2018 Microbiological limits for skin products

  • ASTM E1174-15 Standard Guide for Sampling and Testing for Microbiological Contamination of Skin Care Products

  • EN 13726:2006A1:2015 Microbiological limits for cosmetics and personal care products

    • Compliance with these standards is mandatory for industries that produce skin care products. Failure to comply can result in product recalls, damaged reputations, and loss of customer trust.

    ISO 17516 testing is essential for ensuring the quality and safety of skin care products. This test detects microbial contamination levels, which can pose health risks to consumers.

    The business and technical reasons for conducting ISO 17516 testing include:

  • Ensuring compliance with regulatory requirements

  • Preventing product recalls and reputational damage

  • Maintaining customer trust and loyalty

  • Protecting brand reputation and market share

  • Avoiding costly legal liabilities

    • The consequences of not performing ISO 17516 testing can be severe, including:

  • Product contamination and consumer harm

  • Regulatory fines and penalties

  • Damage to brand reputation and market share

  • Loss of customer trust and loyalty

  • Increased costs due to product recalls and remediation efforts

    • Industries that require ISO 17516 testing include:

  • Cosmetics and personal care products manufacturers

  • Skin care product distributors and retailers

  • Pharmaceutical companies producing skin care-related products

  • Research institutions and universities conducting skin care-related research

    • Risk factors associated with microbial contamination in skin care products include:

  • Health risks to consumers (e.g., infections, allergic reactions)

  • Damage to brand reputation and market share

  • Regulatory fines and penalties

  • Increased costs due to product recalls and remediation efforts

    • Quality assurance and quality control aspects of ISO 17516 testing include:

  • Ensuring that sampling procedures are accurate and representative

  • Maintaining proper laboratory equipment and instrumentation

  • Verifying calibration and validation procedures

  • Implementing adequate quality control measures during testing

    • This test contributes to product safety and reliability by detecting microbial contamination levels, which can pose health risks to consumers.

    The competitive advantages of having ISO 17516 testing performed include:

  • Enhanced brand reputation and market share

  • Improved customer trust and loyalty

  • Reduced regulatory liabilities and fines

  • Increased efficiency and cost savings through proactive quality control measures

    • Cost-benefit analysis reveals that performing ISO 17516 testing can provide significant benefits, including:

  • Reduced costs associated with product recalls and remediation efforts

  • Increased revenue due to improved brand reputation and market share

  • Enhanced customer satisfaction and loyalty

  • Compliance with regulatory requirements and avoidance of fines and penalties.

    • ISO 17516 testing involves a series of steps and procedures designed to detect microbial contamination levels in skin care products. The test conditions and methodology include:

    1. Sample preparation: Samples are collected from the product and prepared for testing.

    2. Testing equipment and instruments: Advanced laboratory equipment and instrumentation, such as spectrophotometers and microbiological analyzers, are used to conduct the tests.

    3. Testing environment requirements: Temperature, humidity, pressure, and other environmental factors are controlled to ensure accurate results.

    4. Sample preparation procedures: Samples are prepared according to standard protocols, including homogenization and dilution.

    5. Testing parameters and conditions: Parameters such as temperature, pH, and inoculum size are adjusted to optimize the testing process.

    6. Measurement and analysis methods: Microbiological analyzers and spectrophotometers are used to measure microbial contamination levels.

    7. Calibration and validation procedures: Equipment is calibrated and validated regularly to ensure accuracy and reliability.

    The test conditions for ISO 17516 testing include:

  • Temperature: 20-25C

  • Humidity: 50-60

  • Pressure: Atmospheric pressure

  • pH: 5.0-6.5

    • The measurement and analysis methods used in ISO 17516 testing include:

  • Microbiological analyzers (e.g., BacT/ALERT, Biomerieux)

  • Spectrophotometers (e.g., Agilent, Shimadzu)

    • Calibration and validation procedures for equipment include:

  • Regular calibration to ensure accuracy

  • Validation of equipment performance against standard reference materials

    • Conclusion

    ISO 17516 microbiological limits for skin products laboratory testing service is a critical component of ensuring product quality and safety. This comprehensive guide has provided an overview of the standard, its requirements, and the benefits of compliance.

    By understanding the importance of ISO 17516 testing, industries can take proactive steps to ensure their products meet regulatory requirements and maintain customer trust and loyalty.

    Appendix

  • Standard numbers related to ISO 17516 testing:

    • ISO 17516:2018 Microbiological limits for skin products

    ASTM E1174-15 Standard Guide for Sampling and Testing for Microbiological Contamination of Skin Care Products

    EN 13726:2006A1:2015 Microbiological limits for cosmetics and personal care products

  • Key terms related to ISO 17516 testing:

    • Microbial contamination

    Skin care products

    Regulatory requirements

    Quality control measures

    Calibration and validation procedures

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