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iso-10993-22-sensitization-test
Claim Substantiation COLIPA Guidelines for Cosmetic Claim SupportEN 15886 Stability Testing of Cosmetic ProductsFDA Cosmetic Labeling Regulations TestingFDA Cosmetic Safety AssessmentFDA Cosmetic Safety Testing GuidanceFDA Guidance for Cosmetic Claim SubstantiationFDA Guidance on Cosmetic TestingFDA Voluntary Cosmetic Registration Program (VCRP) TestingISO 10993-10 Evaluation of Irritation and SensitizationISO 10993-10 Skin Irritation Testing for CosmeticsISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation for Safety TestingISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical CharacterizationISO 10993-18 Chemical Characterization of CosmeticsISO 10993-19 Assessment of Allergic Contact DermatitisISO 10993-22 Sensitization TestingISO 10993-23 Assessment of UV-induced PhototoxicityISO 10993-23 Phototoxicity TestingISO 10993-5 Cytotoxicity TestingISO 11930 Challenge Testing for PreservativesISO 11930 Preservative Efficacy Testing for ClaimsISO 11930-1 Challenge Testing for Preservative EfficacyISO 11930-2 Preservative Testing for Leave-on ProductsISO 11989 Validation of Microbiological MethodsISO 15193 Packaging Testing for ClaimsISO 16128 Natural and Organic Cosmetic Ingredient VerificationISO 16128 Natural Ingredient CalculationISO 16128-2 Natural and Organic Content CalculationISO 16128-3 Methodologies for Natural Cosmetic ClaimsISO 16134 Cosmetic Safety GuidelinesISO 16134 Guidelines for Cosmetics SafetyISO 16134-2 Patch Testing for DermatologyISO 16134-3 Patch Test for Dermatological ClaimsISO 16179 Testing of Antioxidants in CosmeticsISO 16212 Detection of Yeasts and Molds in Cosmetic ProductsISO 17516 Microbial Limits for Cosmetic ClaimsISO 17516 Microbial Quality TestingISO 17516 Microbial TestingISO 21148 Anaerobic Microorganism DetectionISO 21148 Detection of Anaerobic MicroorganismsISO 21149 Aerobic Bacteria EnumerationISO 21149 Enumeration of Aerobic Bacteria for Claim SupportISO 21150 Detection of Pathogens in CosmeticsISO 21150 Microbial Contamination TestingISO 21401 Environmental Impact TestingISO 21401 Environmental Label TestingISO 22715 Cosmetic Product Labelling ComplianceISO 22716 Cosmetic Good Manufacturing Practice Compliance TestingISO 22716 GMP for Cosmetic ProductsISO 24434 Antimicrobial Effectiveness TestingISO 24441 SPF Testing for Sun Care ProductsISO 24441 UVA Protection TestingISO 24442 Microbial Spores EnumerationISO 24442 Spore EnumerationISO 24443 UVA Protection TestingISO 24444 SPF Testing ProtocolISO 24444 Sun Protection Factor (SPF) TestingISO 24475 Microbiological Raw Material TestingISO 24475 Raw Material Microbiological TestingISO 24476 Guidelines for Microbiological MethodsISO 24476 Guidelines for Microbiological TestingISO 31661 Photostability TestingISO 31661-2 UV Stability TestingOECD TG 405 In Vivo Eye Irritation TestingOECD TG 431 In Vitro Skin Corrosion TestingOECD TG 439 In Vitro Skin Irritation Testing for ClaimsOECD TG 442C In Vitro Skin SensitizationOECD TG 442D In Vitro Skin Sensitization Assay

ISO 10993-22 Sensitization Test Laboratory Testing Service Provided by Eurolab: A Comprehensive Guide

The ISO 10993-22 Sensitization Test is a critical laboratory test used to evaluate the potential for medical devices or materials to cause sensitization in humans. This test is an essential part of ensuring the safety and efficacy of medical devices, particularly those that come into contact with the human body.

Legal and Regulatory Framework

The ISO 10993-22 Sensitization Test is governed by a range of international and national standards, including:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • ISO 10993-2:1994 Biological evaluation of medical devices Part 2: Animal welfare requirements

  • ASTM F748-13 Standard Practice for Selecting, Testing, and Specifying Medical and Surgical Materials

  • EN ISO 10993-10:2002 Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in vitro

  • TSE LVD 2020/6 Regulation on the Implementation of Directive 2014/35/EU

    • These standards outline the requirements for conducting the ISO 10993-22 Sensitization Test, including test conditions, methodology, and reporting.

    Standard Development Organizations

    The development of international and national standards is overseen by standard development organizations (SDOs), such as:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These SDOs work together to develop and maintain standards, ensuring consistency and comparability across industries and regions.

    Evolution of Standards

    Standards evolve over time as new technologies and scientific discoveries emerge. Updates to existing standards reflect these changes, enabling laboratories to refine their testing procedures and improve accuracy.

    Standard Numbers and Scope

    The following standard numbers and scopes are relevant to the ISO 10993-22 Sensitization Test:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

    • Scope: Specifies the general principles for biological evaluation of medical devices.

  • ISO 10993-2:1994 Biological evaluation of medical devices Part 2: Animal welfare requirements

    • Scope: Outlines animal welfare requirements for biological testing.

  • ASTM F748-13 Standard Practice for Selecting, Testing, and Specifying Medical and Surgical Materials

    • Scope: Provides guidelines for selecting, testing, and specifying materials used in medical devices.

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for laboratories performing the ISO 10993-22 Sensitization Test. Failure to comply can result in inaccurate or misleading test results, compromising product safety and efficacy.

    Industries that require compliance include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • The ISO 10993-22 Sensitization Test is essential for ensuring the safety and efficacy of medical devices. This test helps identify potential sensitizers, enabling manufacturers to mitigate risks and improve product quality.

    Business and Technical Reasons

    Conducting the ISO 10993-22 Sensitization Test addresses various business and technical needs:

  • Ensures compliance with regulatory requirements

  • Mitigates risk associated with sensitization

  • Improves product safety and efficacy

  • Enhances customer confidence and trust

    • Industries and Sectors

    This test is required by various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Cosmetics and personal care products

    • Risk Factors and Safety Implications

    Sensitization can have significant safety implications, including:

  • Skin reactions

  • Allergic contact dermatitis

  • Respiratory problems

  • Systemic hypersensitivity reactions

    • Quality Assurance and Quality Control Aspects

    The ISO 10993-22 Sensitization Test is subject to strict quality assurance and quality control measures:

  • Standardized testing procedures

  • Calibrated equipment

  • Validated test methods

  • Regular audits and inspections

    • Contribution to Product Safety and Reliability

    This test contributes significantly to product safety and reliability by identifying potential sensitizers, enabling manufacturers to refine their products and improve overall performance.

    Competitive Advantages

    Performing the ISO 10993-22 Sensitization Test can provide competitive advantages:

  • Enhanced product quality

  • Improved customer satisfaction

  • Compliance with regulatory requirements

    • Cost-Benefit Analysis

    While conducting this test may incur costs, the benefits far outweigh the expenses. The cost-benefit analysis is as follows:

    Benefits:

  • Improved product safety and efficacy

  • Enhanced customer confidence and trust

  • Compliance with regulatory requirements

  • Competitive advantages

    • Costs:

  • Laboratory testing fees

  • Equipment and materials costs

  • Personnel training and certification

    • The ISO 10993-22 Sensitization Test involves a range of test conditions and methodologies, including:

  • Cell culture tests (e.g., ELISA)

  • In vitro tests (e.g., irritation testing)

  • Animal studies (e.g., skin sensitization)

    • Test Conditions

    Test conditions are specified in relevant standards, including:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • ISO 10993-2:1994 Biological evaluation of medical devices Part 2: Animal welfare requirements

    • Methodology

    The methodology for the ISO 10993-22 Sensitization Test involves:

  • Preparation of test materials (e.g., extracts, leachates)

  • Cell culture or in vitro testing

  • Data analysis and interpretation

    • Reporting and Interpretation

    Test results are reported and interpreted according to relevant standards and guidelines.

    Conclusion

    In conclusion, the ISO 10993-22 Sensitization Test is a critical laboratory test used to evaluate the potential for medical devices or materials to cause sensitization in humans. This test is essential for ensuring product safety and efficacy, and compliance with regulatory requirements.

    By understanding the standard-related information, standard requirements and needs, and test conditions and methodology, laboratories can refine their testing procedures and improve accuracy.

    Eurolabs Expertise

    As a leading laboratory testing service provider, Eurolab offers expertise in performing the ISO 10993-22 Sensitization Test. Our experienced team is committed to delivering accurate and reliable results, ensuring compliance with regulatory requirements and enhancing product safety and efficacy.

    Contact us today to learn more about our ISO 10993-22 Sensitization Test services.

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

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