EUROLAB
iso-10993-10-preservation-efficacy-in-dermal-products
Preservative Efficacy Testing AOAC 2003.07 Challenge Testing for Preservative EffectivenessAOAC 2007.01 Microbial Challenge Testing for PreservativesAOAC 991.14 Microbial Contamination Analysis in Preserved ProductsAOAC 997.02 Challenge Test Method for Preservative EffectivenessASTM D4014 Preservative Testing for Creams and LotionsASTM D5412 Microbial Limits Testing in Preserved CosmeticsASTM D6422 Preservative Effectiveness in Personal Care ProductsASTM E2180 Antimicrobial Activity of Preservative SystemsASTM E2181 Preservative Efficacy Testing for CosmeticsASTM E2315 Preservation Challenge Test for Cosmetic ProductsASTM E2315 Time-Kill Method for Preservative AssessmentASTM E2315-16 Time-Kill Kinetics for Preservative EffectivenessASTM E2316 Microbial Assessment of Cosmetic PreservativesASTM E2317 Antimicrobial Efficacy of Cosmetic PreservativesASTM E2709 Challenge Tests for Preservative SystemsASTM E2799 Antimicrobial Effectiveness Testing for CosmeticsCOLIPA Guidelines for Preservative Efficacy in CosmeticsEN ISO 11930 Microbial Preservation Testing for Personal CareEN ISO 11930 Microbial Quality and Preservation AssessmentEP 2.6.12 Enumeration of Microorganisms in Preserved ProductsEP 2.6.13 Detection of Specified Microorganisms in Preserved ProductsEP 5.1.3 Challenge Test for Preservative EfficacyEP 5.1.4 Microbial Limits in Preserved IngredientsEP 5.1.5 Microbial Quality Control in Preserved FormulationsFDA 21 CFR 701.3 Microbial Contamination Limits in Preserved ProductsFDA 21 CFR Part 700 Microbial Limits for Preserved CosmeticsFDA BAM Chapter 23 Microbial Pathogen Detection in Preserved ProductsFDA Cosmetic Microbiological Testing GuidanceFDA Guidance on Preservative Testing for Topical ProductsISO 10993-12 Sample Preparation for Preservative TestingISO 11930 Challenge Test of Preservatives in CosmeticsISO 11930 Evaluation of Preservative Efficacy in CosmeticsISO 11930-1 Preservative Challenge Testing for Rinse-off ProductsISO 11930-2 Preservative Testing of Leave-on CosmeticsISO 11932 Validation of Microbial Methods in Preservation TestingISO 11989 Validation of Microbiological Methods in Preserved ProductsISO 16128 Natural and Organic Cosmetic Ingredient PreservationISO 16128-2 Calculation of Natural Preservative ContentISO 16134-3 Testing of Preservative EffectivenessISO 16212 Detection of Yeasts and Molds in Preserved CosmeticsISO 16212 Mold and Yeast Quantification in Preserved CosmeticsISO 17516 Microbial Limits and Preservation TestingISO 18415 Microbial Challenge Test for Personal Care ProductsISO 18593 Microbial Sampling in Preserved ProductsISO 18593 Microbiological Sampling Methods for Preserved ProductsISO 21148 Detection of Anaerobic Microorganisms in Preserved ProductsISO 21148 Detection of Preservative-Resistant MicroorganismsISO 21149 Enumeration of Aerobic Bacteria for Preservative StudiesISO 21149 Enumeration of Microorganisms in Preserved FormulationsISO 21149-1 Enumeration of Aerobic Bacteria in Preserved FormulationsISO 21150 Detection of Pathogens in Preserved CosmeticsISO 21150-1 Microbial Contamination in Cosmetic Raw MaterialsISO 21404 Testing for Microbial Contamination in Preserved CosmeticsISO 21702 Antiviral Efficacy Testing of PreservativesISO 22176 Good Hygiene Practices for Preserved CosmeticsISO 22716 Good Manufacturing Practices for Cosmetic PreservationISO 24434 Enumeration of Aerobic Mesophilic Spores in Preserved ProductsISO 24441 SPF Testing for Preserved SunscreensISO 24442 Enumeration of Aerobic Microbial Spores in ProductsISO 24442 Microbial Spores Enumeration in Preserved ProductsISO 24444 Comparison of Microbiological Test ProtocolsISO 24475 Microbiological Assessment of Preserved Raw MaterialsISO 29621 Categorization of Cosmetic Products by Microbiological RiskISO/TR 19837 Guidelines for Microbiological Risk Assessment of PreservativesISO/TR 19838 Risk Management of Preservatives in CosmeticsISO/TR 19930 Microbiological Test Method Development for PreservativesISO/TR 24476 Selection of Microbiological Test Methods for PreservationISO/TR 29621 Guidelines on Risk Assessment for PreservativesUSP <1227> Validation of Microbial Recovery in Preservative StudiesUSP <1227> Validation of Microbial Recovery in Preservative TestingUSP <1229> Microbial Recovery in Preservative Efficacy TestsUSP <1231> Water Quality for Microbiological Control in Preservative TestingUSP <1625> Microbial Testing of Preserved Topical ProductsUSP <51> Antimicrobial Effectiveness Testing for PreservativesUSP <60> Microbial Limits in Preserved CosmeticsUSP <61> Microbial Enumeration Tests in Preserved Cosmetics

Comprehensive Guide to ISO 10993-10 Preservation Efficacy in Dermal Products Laboratory Testing Service

ISO 10993-10 is a standard developed by the International Organization for Standardization (ISO) that specifies the requirements for preservation efficacy testing of dermal products. This standard is part of the ISO 10993 series, which provides guidelines for the safety and performance evaluation of medical devices.

Legal and Regulatory Framework

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

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

  • EN 13726-3:2006 (Preservation efficacy testing of water for human consumption - Part 3: Requirements and test methods)

  • TSE ISO 10993-10:2012 (Preservation efficacy testing of dermal products)

    • These standards are developed and maintained by standard development 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

    Standard development organizations play a crucial role in maintaining and updating standards. They bring together experts from various industries to develop, revise, and maintain standards that reflect the latest scientific knowledge and technological advancements.

    International and National Standards

    The following international and national standards apply to this specific laboratory test:

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

  • EN 13726-3:2006 (Preservation efficacy testing of water for human consumption - Part 3: Requirements and test methods)

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for industries that produce dermal products, including:

  • Cosmetics manufacturers

  • Pharmaceutical companies

  • Medical device manufacturers

    • Failure to comply with these standards can result in product recalls, regulatory fines, and damage to brand reputation.

    Standard Evolution and Updates

    Standards evolve over time as new scientific knowledge and technological advancements become available. Standard development organizations continuously review and update standards to ensure they remain relevant and effective.

    Specific Standard Numbers and Scope

    The following are specific standard numbers and their scope:

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

    • Applies to preservation efficacy testing of dermal products

    Covers microbiological, chemical, and physical aspects

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

    • Applies to preservation efficacy testing of dermal products

    Covers microbiological and chemical aspects

    Industry-Specific Examples

    Examples of industries that require this testing service include:

  • Cosmetics manufacturers: must test their products for preservation efficacy to ensure they meet regulatory requirements

  • Pharmaceutical companies: must test their products for preservation efficacy to ensure they are safe and effective for human use

  • Medical device manufacturers: must test their products for preservation efficacy to ensure they meet regulatory requirements

    • Why this Specific Test is Needed

    The ISO 10993-10 Preservation Efficacy in Dermal Products testing service is essential for ensuring the safety and effectiveness of dermal products. This test helps manufacturers detect potential microbiological, chemical, or physical contamination that may affect product quality.

    Business and Technical Reasons

    Conducting this test has both business and technical reasons:

  • Regulatory compliance: failure to comply with standards can result in regulatory fines, product recalls, and damage to brand reputation

  • Product safety: testing helps ensure products meet regulatory requirements and are safe for human use

  • Quality assurance: testing helps manufacturers detect potential defects or contamination that may affect product quality

    • Consequences of Not Performing this Test

    Not performing this test can have serious consequences:

  • Regulatory fines and penalties

  • Product recalls and damage to brand reputation

  • Failure to comply with regulatory requirements

  • Potential harm to consumers due to contaminated products

    • Industries and Sectors that Require this Testing

    The following industries and sectors require this testing service:

  • Cosmetics manufacturers

  • Pharmaceutical companies

  • Medical device manufacturers

    • Risk Factors and Safety Implications

    This test helps detect potential microbiological, chemical, or physical contamination that may affect product quality. Failure to detect these contaminants can result in serious safety implications for consumers.

    Quality Assurance and Quality Control Aspects

    Conducting this test is essential for maintaining quality assurance and quality control:

  • Helps manufacturers detect potential defects or contamination

  • Ensures products meet regulatory requirements

  • Supports business operations by reducing the risk of product recalls, regulatory fines, and damage to brand reputation

    • Standard Requirements

    The following are standard requirements for preservation efficacy testing of dermal products:

  • Microbiological aspects: testing for microbial contamination, including bacteria, yeast, and mold

  • Chemical aspects: testing for chemical contaminants, including heavy metals and pesticides

  • Physical aspects: testing for physical contamination, including particulate matter

    • Test Methods

    The following test methods are used to evaluate preservation efficacy in dermal products:

  • Microbiological tests: agar diffusion, broth dilution, and membrane filtration

  • Chemical tests: high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS)

  • Physical tests: particle size analysis, scanning electron microscopy (SEM), and transmission electron microscopy (TEM)

    • Test Frequency

    The frequency of testing depends on various factors, including:

  • Product type

  • Manufacturing process

  • Regulatory requirements

    • Standardized Test Methods

    Conducting this test using standardized methods helps ensure consistency and accuracy. Standardized test methods include:

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

    • Test Sample Preparation

    The following steps are involved in preparing test samples:

  • Selecting representative product samples

  • Preparing samples according to standard procedures

  • Conducting tests using standardized methods

    • Interpretation of Results

    The results of this test must be interpreted carefully, taking into account the following factors:

  • Test method used

  • Sample preparation

  • Test conditions

    • Standardized Reporting Formats

    Conducting this test and reporting results in a standardized format helps ensure consistency and accuracy. Standardized reporting formats include:

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

    • Continuous Monitoring

    Conducting this test regularly is essential for maintaining quality assurance and quality control. Continuous monitoring helps detect potential defects or contamination early on, reducing the risk of product recalls, regulatory fines, and damage to brand reputation.

    What is Preservation Efficacy Testing?

    Preservation efficacy testing evaluates the ability of a product to prevent microbiological, chemical, or physical contamination. This test helps manufacturers detect potential defects or contamination that may affect product quality.

    Why is this Test Necessary?

    Conducting this test is essential for ensuring product safety and compliance with regulatory requirements:

  • Helps detect potential microbiological, chemical, or physical contamination

  • Ensures products meet regulatory requirements

  • Supports business operations by reducing the risk of product recalls, regulatory fines, and damage to brand reputation

    • Benefits of Preservation Efficacy Testing

    Conducting this test has several benefits:

  • Ensures product safety and compliance with regulatory requirements

  • Reduces the risk of product recalls, regulatory fines, and damage to brand reputation

  • Supports business operations by maintaining quality assurance and quality control

    • How is this Test Conducted?

    The following steps are involved in conducting preservation efficacy testing:

  • Selecting representative product samples

  • Preparing samples according to standard procedures

  • Conducting tests using standardized methods

  • Interpreting results carefully, taking into account test method used, sample preparation, and test conditions

    • What is the Frequency of Testing?

    The frequency of testing depends on various factors, including:

  • Product type

  • Manufacturing process

  • Regulatory requirements

    • Who Can Benefit from this Test?

    Manufacturers of dermal products can benefit from this test, including:

  • Cosmetics manufacturers

  • Pharmaceutical companies

  • Medical device manufacturers

    • In conclusion, the ISO 10993-10 Preservation Efficacy in Dermal Products testing service is essential for ensuring product safety and compliance with regulatory requirements. Conducting this test helps detect potential microbiological, chemical, or physical contamination that may affect product quality.

    Appendix A: Glossary of Terms

    The following are definitions of key terms used in this guide:

  • Preservation efficacy: the ability of a product to prevent microbiological, chemical, or physical contamination

  • Dermal products: products intended for use on human skin, including cosmetics and pharmaceuticals

  • Microbiological aspects: testing for microbial contamination, including bacteria, yeast, and mold

  • Chemical aspects: testing for chemical contaminants, including heavy metals and pesticides

  • Physical aspects: testing for physical contamination, including particulate matter

    • Appendix B: References

    The following are references cited in this guide:

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

  • EN 13726-3:2006 (Preservation efficacy testing of water for human consumption - Part 3: Requirements and test methods)

    • Appendix C: Standardized Test Methods

    The following are standardized test methods used to evaluate preservation efficacy in dermal products:

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

    • Appendix D: Test Sample Preparation

    The following steps are involved in preparing test samples:

  • Selecting representative product samples

  • Preparing samples according to standard procedures

    • Appendix E: Interpretation of Results

    The results of this test must be interpreted carefully, taking into account the following factors:

  • Test method used

  • Sample preparation

  • Test conditions

    • Appendix F: Standardized Reporting Formats

    Conducting this test and reporting results in a standardized format helps ensure consistency and accuracy. Standardized reporting formats include:

  • ISO 10993-10:2010 (Preservation efficacy in dermal products)

  • ASTM F2029-13 (Standard Practice for Evaluating the Preservation Efficacy of Dermal Products)

    • Appendix G: Continuous Monitoring

    Conducting this test regularly is essential for maintaining quality assurance and quality control. Continuous monitoring helps detect potential defects or contamination early on, reducing the risk of product recalls, regulatory fines, and damage to brand reputation.

    This concludes our guide to preservation efficacy testing in dermal products. We hope you found it informative and helpful.

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