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iso-14155-clinical-investigation-of-medical-devices-on-skin
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 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 14155 Clinical Investigation of Medical Devices on Skin Testing Services

ISO 14155 is an international standard that outlines the requirements for clinical investigations of medical devices on skin. This standard is published by the International Organization for Standardization (ISO) and is widely recognized as a benchmark for ensuring the safety and efficacy of medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 14155 clinical investigation of medical devices on skin testing is governed by various international and national standards, including:

  • ISO 14155:2019: Clinical Investigation of Medical Devices for Human Subjects - Particular Requirements for In Vitro Diagnostics

  • EN ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects - Particular Requirements for In Vitro Diagnostics (European Standard)

  • ASTM F2008-19: Standard Guide for Clinical Investigation of Medical Devices in the Skin

    • These standards ensure that medical devices are thoroughly tested and validated to meet safety and efficacy requirements before being brought to market.

    International and National Standards

    The following international and national standards apply to ISO 14155 clinical investigation of medical devices on skin testing:

  • ISO 14971:2019: Medical Devices - Application of Risk Management to Medical Devices

  • EN 13485:2016A1:2018: Medical Devices Quality management systems Requirements for regulatory purposes (European Standard)

  • TSE 2223:2012: Medical devices General requirements for safety and performance

    • These standards provide a framework for ensuring that medical devices are designed, developed, and tested to meet strict safety and efficacy requirements.

    Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining international and national standards. Some of the key standard development organizations involved in ISO 14155 include:

  • ISO: International Organization for Standardization

  • CEN: European Committee for Standardization

  • ASTM: American Society for Testing and Materials

    • These organizations work together to develop and maintain standards that ensure safety, efficacy, and quality of medical devices.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, science, and regulatory requirements. New editions of standards are released as necessary to address emerging issues or concerns. For example:

  • ISO 14155:2019 replaced the previous edition (ISO 14155:2010).

  • EN ISO 14155:2020 is the latest European standard for clinical investigation of medical devices on skin testing.

    • Standard Compliance Requirements

    Compliance with ISO 14155 requires that manufacturers and regulatory bodies adhere to strict requirements, including:

  • Risk management: Manufacturers must identify, assess, and mitigate risks associated with their devices.

  • Design and development: Devices must be designed and developed in accordance with established standards and guidelines.

  • Testing and validation: Devices must undergo rigorous testing and validation to ensure safety and efficacy.

    • Industry-Specific Examples

    Industry-specific examples of ISO 14155 clinical investigation of medical devices on skin testing include:

  • Skin contact lens: Manufacturers must conduct thorough testing to ensure that the device does not cause any adverse reactions or complications.

  • Transdermal patches: Testing must focus on ensuring that the patch adheres properly to the skin and releases medication safely.

    • Statistical Data and Research Findings

    Statistical data and research findings support the importance of ISO 14155 clinical investigation of medical devices on skin testing. For example:

  • A study published in the Journal of Clinical Investigation found that adherence to ISO 14155 guidelines reduced adverse event rates by 50.

  • Another study published in the European Journal of Dermatology found that use of transdermal patches resulted in improved patient compliance and better treatment outcomes.

    • Conclusion

    ISO 14155 clinical investigation of medical devices on skin testing is a critical component of ensuring safety, efficacy, and quality of medical devices. Manufacturers must adhere to strict requirements outlined in international and national standards, including ISO 14155:2019, EN ISO 14155:2020, and ASTM F2008-19.

    ISO 14155 clinical investigation of medical devices on skin testing is necessary for several reasons:

    Business and Technical Reasons

    Business and technical reasons drive the need for ISO 14155 clinical investigation of medical devices on skin testing. For example:

  • Regulatory compliance: Manufacturers must comply with strict regulatory requirements to ensure that their devices meet safety and efficacy standards.

  • Quality assurance: Testing ensures that devices are safe, effective, and reliable.

    • Consequences of Not Performing the Test

    Consequences of not performing ISO 14155 clinical investigation of medical devices on skin testing can be severe:

  • Product recalls: Devices may need to be recalled from market if they do not meet safety and efficacy standards.

  • Liability issues: Manufacturers may face liability for adverse events or complications resulting from non-compliance with standards.

    • Industry-Specific Examples

    Industry-specific examples of the importance of ISO 14155 clinical investigation of medical devices on skin testing include:

  • Skin contact lens: Non-compliance can result in eye irritation, allergic reactions, or other complications.

  • Transdermal patches: Failure to adhere to standards can lead to reduced efficacy, increased risk of adverse events, or device failure.

    • Statistical Data and Research Findings

    Statistical data and research findings demonstrate the importance of ISO 14155 clinical investigation of medical devices on skin testing. For example:

  • A study published in the Journal of Clinical Investigation found that adherence to ISO 14155 guidelines reduced adverse event rates by 50.

  • Another study published in the European Journal of Dermatology found that use of transdermal patches resulted in improved patient compliance and better treatment outcomes.

    • Conclusion

    ISO 14155 clinical investigation of medical devices on skin testing is essential for ensuring safety, efficacy, and quality of medical devices. Manufacturers must adhere to strict requirements outlined in international and national standards, including ISO 14155:2019, EN ISO 14155:2020, and ASTM F2008-19.

    Industry-specific examples of ISO 14155 clinical investigation of medical devices on skin testing include:

    Skin Contact Lens

    Skin contact lens manufacturers must conduct thorough testing to ensure that the device does not cause any adverse reactions or complications. For example:

  • Adhesion: Testing must focus on ensuring that the lens adheres properly to the eye.

  • Irritation: Manufacturers must assess potential irritation caused by chemicals used in the production process.

    • Transdermal Patches

    Transdermal patch manufacturers must conduct rigorous testing to ensure that the device releases medication safely and effectively. For example:

  • Adhesion: Testing must focus on ensuring that the patch adheres properly to the skin.

  • Release rate: Manufacturers must assess the release rate of medication from the patch.

    • Statistical Data and Research Findings

    Statistical data and research findings support the importance of ISO 14155 clinical investigation of medical devices on skin testing. For example:

  • A study published in the Journal of Clinical Investigation found that adherence to ISO 14155 guidelines reduced adverse event rates by 50.

  • Another study published in the European Journal of Dermatology found that use of transdermal patches resulted in improved patient compliance and better treatment outcomes.

    • Conclusion

    ISO 14155 clinical investigation of medical devices on skin testing is essential for ensuring safety, efficacy, and quality of medical devices. Manufacturers must adhere to strict requirements outlined in international and national standards, including ISO 14155:2019, EN ISO 14155:2020, and ASTM F2008-19.

    Statistical data and research findings demonstrate the importance of ISO 14155 clinical investigation of medical devices on skin testing. For example:

    A Study Published in the Journal of Clinical Investigation

    A study published in the Journal of Clinical Investigation found that adherence to ISO 14155 guidelines reduced adverse event rates by 50. The study analyzed data from over 10,000 patients and found that compliance with standards resulted in improved safety and efficacy outcomes.

  • Adverse events: Adherence to ISO 14155 guidelines reduced adverse event rates by 50.

  • Efficacy: Compliance with standards resulted in improved treatment outcomes.

    • Another Study Published in the European Journal of Dermatology

    Another study published in the European Journal of Dermatology found that use of transdermal patches resulted in improved patient compliance and better treatment outcomes. The study analyzed data from over 5,000 patients and found that transdermal patches increased adherence to medication regimens.

  • Compliance: Use of transdermal patches increased patient compliance by 30.

  • Efficacy: Improved treatment outcomes were observed in patients using transdermal patches.

    • Conclusion

    Statistical data and research findings demonstrate the importance of ISO 14155 clinical investigation of medical devices on skin testing. Manufacturers must adhere to strict requirements outlined in international and national standards, including ISO 14155:2019, EN ISO 14155:2020, and ASTM F2008-19.

    Conclusion

    ISO 14155 clinical investigation of medical devices on skin testing is essential for ensuring safety, efficacy, and quality of medical devices. Manufacturers must adhere to strict requirements outlined in international and national standards, including ISO 14155:2019, EN ISO 14155:2020, and ASTM F2008-19.

    By following these guidelines, manufacturers can ensure that their devices meet strict safety and efficacy standards, reducing the risk of adverse events and improving treatment outcomes.

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