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iso-10993-10-evaluation-of-skin-irritation-and-sensitization
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 10993-11 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 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 10993-10 Evaluation of Skin Irritation and Sensitization Laboratory Testing Service: A Comprehensive Guide

The ISO 10993-10 standard is part of the International Organization for Standardizations (ISO) comprehensive framework for evaluating the safety and biocompatibility of medical devices. This specific standard focuses on the evaluation of skin irritation and sensitization, which are critical aspects of ensuring the safe use of medical devices.

Legal and Regulatory Framework

The ISO 10993-10 standard is recognized worldwide as a benchmark for evaluating skin irritation and sensitization. In Europe, it is harmonized with the EUs Medical Device Regulation (MDR) and Directive 93/42/EEC on medical devices. Similarly, in the United States, the FDA recognizes ISO 10993-10 as an acceptable method for evaluating skin irritation and sensitization.

International and National Standards

The following standards are relevant to ISO 10993-10:

  • ISO 10993-1:2018 - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • EN ISO 10993-10:2013 - Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in addition to the key tissue types

  • ASTM F2423-08 (2015) - Standard Practice for In Vitro Assessment of Biocompatibility of Medical Devices Using Test System Sensitization Methods

    • Standard Development Organizations

    The ISO 10993 series is developed by the Technical Committee ISO/TC 194, Biological and clinical evaluation of medical devices. This committee is responsible for ensuring that standards are scientifically valid, technically sound, and practically implementable.

    Evolution of Standards

    Standards evolve over time as new information becomes available or as scientific understanding improves. For example, the ISO 10993-1 standard was revised in 2018 to include a risk management process for evaluating biological hazards associated with medical devices.

    Specific Standard Numbers and Scope

    The following are specific standard numbers related to skin irritation and sensitization:

  • ISO 10993-10:2013 - Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in addition to the key tissue types

  • EN ISO 10993-10:2013 - Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in addition to the key tissue types

    • Standard Compliance Requirements

    Compliance with ISO 10993-10 is mandatory for manufacturers of medical devices that come into contact with the skin, such as wound dressings, topical creams, and implantable devices.

    In addition to regulatory compliance, manufacturers may also choose to implement ISO 10993-10 as a voluntary standard to ensure the highest level of product safety and biocompatibility. This can be particularly important for medical devices intended for use in high-risk applications or where patient safety is paramount.

    Why this Specific Test is Needed and Required

    The ISO 10993-10 standard provides a scientifically valid method for evaluating skin irritation and sensitization. This is essential because many medical devices come into contact with the skin, which can lead to adverse reactions such as irritation or sensitization.

    Business and Technical Reasons for Conducting ISO 10993-10 Evaluation of Skin Irritation and Sensitization Testing

    There are several reasons why manufacturers may choose to conduct ISO 10993-10 testing:

  • Compliance with regulatory requirements

  • Ensuring product safety and biocompatibility

  • Reducing the risk of adverse reactions

  • Protecting patient safety

  • Improving product reliability and performance

    • Consequences of Not Performing this Test

    Failure to perform ISO 10993-10 testing can result in serious consequences, including:

  • Adverse reactions or injuries to patients

  • Product recalls or withdrawals from the market

  • Loss of business reputation or customer trust

  • Non-compliance with regulatory requirements

  • Inability to demonstrate product safety and biocompatibility

    • Industries and Sectors that Require this Testing

    The following industries and sectors require ISO 10993-10 testing:

  • Medical device manufacturers (e.g., wound dressings, implantable devices)

  • Pharmaceutical companies (e.g., topical creams, ointments)

  • Cosmetics manufacturers (e.g., skin care products, fragrances)

    • Risk Factors and Safety Implications

    The following risk factors and safety implications are associated with ISO 10993-10 testing:

  • Skin irritation or sensitization

  • Allergic reactions or anaphylaxis

  • Infections or abscesses

  • Device failure or malfunction

    • Quality Assurance and Quality Control Aspects

    ISO 10993-10 testing requires a quality assurance and quality control approach that includes:

  • Documentation of testing procedures and results

  • Calibration and validation of equipment

  • Training of personnel involved in testing

  • Regular audits to ensure compliance with standard requirements

    • In addition to quality assurance and quality control, ISO 10993-10 testing also requires a risk management approach that identifies potential hazards associated with medical devices. This includes:

  • Identifying potential biological hazards (e.g., skin irritation, sensitization)

  • Evaluating the severity of adverse reactions

  • Implementing controls or mitigations to minimize risks

    • The following are additional requirements for ISO 10993-10 testing:

  • Selection of test methods and parameters

  • Preparation of test samples and materials

  • Conducting tests according to standard procedures

  • Evaluating results and reporting findings

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