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iso-15223-1-symbols-for-indicating-skin-contact-in-medical-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 10993-22 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 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 15223-1 Symbols for Indicating Skin Contact in Medical Devices Testing Services

ISO 15223-1:2016 is an international standard that specifies the symbols to be used on medical devices to indicate skin contact. The standard is published by the International Organization for Standardization (ISO) and is part of the ISO 15223 series, which deals with the labeling of medical devices.

Legal and Regulatory Framework

The use of ISO 15223-1:2016 is mandatory in many countries, including the European Union (EU), where it has been incorporated into the Medical Device Regulation (MDR) as Annex VIII. The standard is also referenced in the US FDAs guidance documents for medical device labeling.

International and National Standards

ISO 15223-1:2016 is an international standard that has been adopted by many countries, including:

  • European Union: EN ISO 15223-1:2016

  • United States: ASTM F1323-18 (American Society for Testing and Materials)

  • Canada: CAN/CSA Z8000-10 (Canadian Standards Association)

    • Standard Development Organizations

    The development of ISO 15223-1:2016 was led by the International Organization for Standardization (ISO) in collaboration with other standard development organizations, including:

  • European Committee for Electrotechnical Standardization (CENELEC)

  • American Society for Testing and Materials (ASTM)

  • Canadian Standards Association (CSA)

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulatory requirements, or industry practices. ISO 15223-1:2016 was published in 2016 and has undergone several updates since then.

    Specific Standard Numbers and Scope

    ISO 15223-1:2016 specifies the symbols to be used on medical devices to indicate skin contact. The standard includes:

  • A list of approved symbols for indicating skin contact

  • Rules for the use of these symbols, including formatting and placement requirements

    • Standard Compliance Requirements

    Compliance with ISO 15223-1:2016 is required for medical devices that are intended to come into contact with human skin. Failure to comply can result in regulatory non-compliance, product recalls, or even legal action.

    Industries and Sectors

    The use of ISO 15223-1:2016 is not limited to a specific industry or sector. Medical devices from various industries, including:

  • Orthopedic implants

  • Wound care products

  • Disposable gloves

    • are subject to this standard.

    Risk Factors and Safety Implications

    Failure to comply with ISO 15223-1:2016 can have serious safety implications for patients. Incorrect labeling of medical devices can lead to:

  • Adverse reactions

  • Infections

  • Product failures

    • Quality Assurance and Quality Control Aspects

    Compliance with ISO 15223-1:2016 is an essential aspect of quality assurance and quality control in medical device manufacturing.

    The need for testing to ensure compliance with ISO 15223-1:2016 arises from the following reasons:

  • Regulatory Compliance: Medical devices must comply with regulatory requirements, including labeling standards.

  • Product Safety: Incorrect labeling can lead to adverse reactions, infections, or product failures.

  • Customer Confidence: Accurate and consistent labeling builds customer trust and confidence in medical device products.

    • Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Regulatory non-compliance

  • Product recalls

  • Legal action

    • Industries and Sectors That Require This Testing

    Medical devices from various industries, including:

  • Orthopedic implants

  • Wound care products

  • Disposable gloves

    • are subject to this standard.

    Risk Factors and Safety Implications

    Failure to comply with ISO 15223-1:2016 can have serious safety implications for patients. Incorrect labeling of medical devices can lead to:

  • Adverse reactions

  • Infections

  • Product failures

    • Quality Assurance and Quality Control Aspects

    Compliance with ISO 15223-1:2016 is an essential aspect of quality assurance and quality control in medical device manufacturing.

    The testing procedure for ISO 15223-1:2016 involves the following steps:

    1. Sample Preparation: The test sample must be properly prepared to ensure accurate results.

    2. Testing Equipment and Instruments: Specific equipment and instruments are required to conduct this test, including a microscope and a computer with image analysis software.

    3. Testing Environment Requirements: The testing environment must meet specific requirements, including temperature (20C 5C), humidity (50 10), and lighting conditions.

    4. Measurement and Analysis: The symbols on the medical device are measured and analyzed using a microscope and image analysis software.

    Test Report

    The test report must include:

  • A description of the test sample

  • The testing equipment and instruments used

  • The results of the measurement and analysis, including any corrections or adjustments

    • Certification and Accreditation

    ISO 15223-1:2016 is certified by various certification bodies, such as ISO/IEC 17025.

    Test Report Validation

    The test report must be validated to ensure accuracy and reliability.

    Continuous Improvement

    Compliance with ISO 15223-1:2016 is not a one-time process but rather an ongoing effort to continuously improve the quality of medical devices.

    Conclusion

    In conclusion, compliance with ISO 15223-1:2016 is essential for ensuring the safety and effectiveness of medical devices. Medical device manufacturers must ensure that their products comply with this standard by performing regular testing and validation.

    The test report format for ISO 15223-1:2016 includes:

  • Cover Page: The cover page includes information about the test sample, including its name, description, and product category.

  • Introduction: The introduction provides an overview of the testing procedure, including any relevant background information or assumptions made during the testing process.

  • Test Methodology: This section describes the specific testing method used to measure the symbols on the medical device.

  • Results: This section presents the results of the measurement and analysis, including any corrections or adjustments.

  • Conclusion: The conclusion summarizes the findings and provides recommendations for future improvements.

    • ISO 15223-1:2016 is certified by various certification bodies, such as:

  • ISO/IEC 17025

  • EN ISO/IEC 17065

  • ANSI/NCSL Z540-5

    • Continuing Education and Training

    Medical device manufacturers must ensure that their personnel are trained and qualified to perform this test.

    Standards evolve over time to reflect changes in technology, regulatory requirements, or industry practices. ISO 15223-1:2016 has undergone several updates since its initial publication in 2016.

    Future Developments

    New developments are expected to emerge as the standard evolves to meet emerging trends and technologies.

    Recommendations for Future Research and Development

    Researchers and developers should investigate new testing methods, instruments, or techniques that can improve the accuracy and reliability of this test.

    Conclusion

    In conclusion, compliance with ISO 15223-1:2016 is essential for ensuring the safety and effectiveness of medical devices. Medical device manufacturers must ensure that their products comply with this standard by performing regular testing and validation.

    By following the guidelines outlined in this comprehensive guide, medical device manufacturers can ensure compliance with ISO 15223-1:2016 and maintain customer confidence and regulatory compliance.

    The following is an example of a test report for a medical device that complies with ISO 15223-1:2016:

  • Cover Page

    • Test Sample Name: XYZ Disposable Glove

    Description: A disposable glove used to protect the hands from contamination.

    Product Category: Medical Device, Personal Protective Equipment

  • Introduction

    • Background: The medical device industry is subject to strict regulatory requirements, including labeling standards.

    Purpose: This test report describes the testing procedure and results for the XYZ Disposable Glove.

    Assumptions: The testing procedure assumes that the test sample is representative of the products typical labeling condition.

  • Test Methodology

    • Test Procedure: The test sample was measured using a microscope and image analysis software to determine the size and accuracy of the symbol on the medical device.

    Testing Equipment and Instruments: A Nikon Microscope (Model E-600) with an Olympus Camera (Model DP72) was used for this test.

  • Results

    • Measurement Results: The measurement results are presented in the following table:

    Symbol Size (mm) Accuracy ()

    --- --- ---

    1.00 0.10 95 5

  • Conclusion

    • Summary of Findings: The testing procedure and results for the XYZ Disposable Glove are presented in this test report.

    Recommendations for Future Improvements: Based on these results, we recommend revising the labeling design to improve accuracy.

    By following this comprehensive guide, medical device manufacturers can ensure compliance with ISO 15223-1:2016 and maintain customer confidence and regulatory compliance.

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