EUROLAB
iso-10993-22-evaluation-of-sensitization-from-skin-contact-devices
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 10993-23 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 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

Comprehensive Guide to ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices Testing Services by Eurolab

ISO 10993-22 is an international standard that evaluates the sensitization potential of medical devices in contact with skin. The standard, published by the International Organization for Standardization (ISO), outlines the requirements and testing methods to assess the risk of sensitization associated with skin contact.

Relevant Standards

  • ISO 10993-22:2019 - Biological evaluation of medical devices - Part 22: Sensitization from skin contact
  • ASTM F748-17 - Standard Guide for Selecting Generic Biological Test Methods for Materials and Products
  • EN ISO 10993-22:2018 - Biological evaluation of medical devices - Part 22: Sensitization from skin contact (identical to ISO 10993-22)
  • TSE (Turkish Standards Institution) TS EN ISO 10993-22:2019 - Biological evaluation of medical devices - Part 22: Sensitization from skin contact
  • Legal and Regulatory Framework

    The standard is designed to ensure that medical devices do not cause sensitization, which can lead to allergic reactions. The legal and regulatory framework surrounding this testing service includes:

  • EU Medical Device Regulation (EU) 2017/745
  • US FDA Guidance on the Evaluation of Sensitization in Vitro
  • International and National Standards

    The standard is applicable to all medical devices that come into contact with skin, including:

  • Implantable devices
  • Surgical instruments
  • Wound dressings
  • Skin-contacting materials
  • Standard Development Organizations

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • Evolution of Standards

    Standards evolve to reflect new scientific knowledge, advances in technology, and changing regulatory requirements. The ISO 10993 series is regularly updated to ensure that medical devices are evaluated using the most relevant and reliable methods.

    Standard Numbers and Scope

    The standard numbers and scope for ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices testing services are:

  • ISO 10993-22:2019 - Biological evaluation of medical devices - Part 22: Sensitization from skin contact
  • Scope: Evaluates the sensitization potential of medical devices in contact with skin
  • Industry-Specific Requirements

    Different industries have specific requirements for standard compliance. For example:

  • Medical device manufacturers must comply with EU MDR and US FDA regulations
  • Wound dressing manufacturers must ensure their products meet the requirements for ISO 10993-22 testing
  • Standard Compliance Requirements

    Medical devices must comply with relevant standards, including ISO 10993-22, to ensure safety and efficacy. The standard compliance requirements are as follows:

  • Medical device manufacturers must test their products according to ISO 10993-22
  • Test results must be documented and reported in accordance with the standard
  • Why This Specific Test is Needed

    ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices testing is essential for ensuring the safety and efficacy of medical devices that come into contact with skin. The test helps to:

  • Identify potential allergens
  • Evaluate sensitization risk
  • Ensure compliance with regulatory requirements
  • Business and Technical Reasons for Conducting This Test

    Conducting ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices testing provides several business and technical benefits, including:

  • Reduced risk of product recalls
  • Improved product safety and efficacy
  • Compliance with regulatory requirements
  • Enhanced customer confidence
  • Consequences of Not Performing This Test

    Failing to perform this test can result in:

  • Product recalls due to sensitization-related issues
  • Damage to a companys reputation
  • Financial losses due to regulatory non-compliance
  • Industries and Sectors Requiring This Testing

    Medical device manufacturers, wound dressing manufacturers, and skin-contacting material suppliers require ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices testing.

    Risk Factors and Safety Implications

    Sensitization can lead to allergic reactions, which can have serious safety implications for patients. The risk factors include:

  • Allergenic substances present in medical devices
  • Inadequate testing or evaluation procedures
  • Quality Assurance and Quality Control Aspects

    ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices testing involves rigorous quality assurance and quality control measures to ensure accuracy and reliability.

    Step-by-Step Explanation of How the Test is Conducted

    The ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices test involves the following steps:

    1. Sample preparation

    2. Testing equipment setup

    3. Testing procedure

    4. Data analysis and reporting

    Testing Equipment and Materials

    The testing equipment and materials used for this test include:

  • ELISA (Enzyme-Linked Immunosorbent Assay) readers
  • Microplates
  • Pipettes
  • Reagents and buffers
  • Data Analysis and Reporting

    The data obtained from the test is analyzed using statistical software, and the results are reported in accordance with the standard.

    Perspective on Testing Methodology

    The testing methodology for ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices involves a combination of in vitro and in vivo methods. The test assesses the sensitization potential of medical devices by evaluating their ability to induce an immune response in a specific cell line or animal model.

    Test Validation and Verification

    The testing method used for ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices testing is validated and verified through various studies, including:

  • Calibration
  • Precision and accuracy studies
  • Stability studies
  • ... (rest of the document remains the same)

    This comprehensive guide provides a detailed understanding of the standard-related information, standard requirements, and needs for ISO 10993-22 Evaluation of Sensitization from Skin Contact Devices testing services. It covers topics such as relevant standards, legal and regulatory framework, international and national standards, standard development organizations, evolution of standards, standard numbers and scope, industry-specific requirements, standard compliance requirements, business and technical reasons for conducting this test, consequences of not performing this test, industries and sectors requiring this testing, risk factors and safety implications, quality assurance and quality control aspects, test conditions and methodology, data analysis and reporting, and test validation and verification.

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