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iso-10993-23-evaluation-of-phototoxicity-and-photoallergy
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 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 10993-23 Evaluation of Phototoxicity and Photoallergy Testing Services: A Comprehensive Guide

ISO 10993-23 is a part of the ISO 10993 series, which outlines the requirements for evaluating the biocompatibility of medical devices. Specifically, ISO 10993-23 deals with the evaluation of phototoxicity and photoallergy, two forms of adverse reactions that can occur when materials are exposed to light.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-23 testing is governed by various international and national standards. Some of the key regulations include:

  • European Unions Medical Device Regulation (MDR) 2017/745

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • Turkish Standards Institution (TSE)

    • These regulations outline the requirements for medical device manufacturers to ensure that their products are safe for use in humans. ISO 10993-23 testing is a critical component of this process, as it helps to identify potential phototoxicity and photoallergy hazards.

    Standard Development Organizations

    Standard development organizations play a crucial role in creating and maintaining standards like ISO 10993-23. Some key organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • Turkish Standards Institution (TSE)

    • These organizations work together to develop and revise standards, ensuring that they remain relevant and effective.

    Evolution of Standards

    Standards evolve over time as new technologies and research emerge. ISO 10993-23 is no exception, with revisions occurring regularly to reflect the latest scientific understanding and regulatory requirements.

    Standard Numbers and Scope

    Some key standard numbers related to ISO 10993-23 include:

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

  • ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Guidance on the selection of tests for interactions with blood

  • ISO 10993-23:2020 Biological evaluation of medical devices - Part 23: Evaluation of phototoxicity and photoallergy

    • Standard Compliance Requirements

    Manufacturers must comply with these standards to ensure that their products meet regulatory requirements. This includes conducting appropriate testing, such as ISO 10993-23 evaluation of phototoxicity and photoallergy.

    Industry-Specific Examples and Case Studies

    Here are a few examples:

  • A manufacturer of contact lenses was required to conduct ISO 10993-23 testing to ensure that their product did not cause adverse reactions when exposed to light.

  • A developer of medical implants needed to evaluate the phototoxicity and photoallergy potential of their material using ISO 10993-23.

    • Risk Assessment and Mitigation

    ISO 10993-23 testing helps manufacturers identify potential risks associated with phototoxicity and photoallergy. By conducting this testing, manufacturers can mitigate these risks and ensure that their products are safe for use.

    Quality Assurance and Compliance Benefits

    Conducting ISO 10993-23 testing provides several benefits, including:

  • Ensuring compliance with regulatory requirements

  • Identifying potential risks associated with phototoxicity and photoallergy

  • Mitigating these risks through appropriate design and manufacturing changes

    • Competitive Advantages and Market Positioning

    Conducting ISO 10993-23 testing can provide a competitive advantage in the market by:

  • Demonstrating a commitment to quality and safety

  • Ensuring compliance with regulatory requirements

  • Building customer confidence and trust

    • Cost Savings and Efficiency Improvements

    By conducting ISO 10993-23 testing, manufacturers can identify potential risks associated with phototoxicity and photoallergy early on. This can help prevent costly design and manufacturing changes down the line.

    Legislative and Regulatory Compliance Benefits

    Conducting ISO 10993-23 testing ensures that manufacturers comply with regulatory requirements. This helps to prevent fines and penalties associated with non-compliance.

    Customer Confidence and Trust Building

    By demonstrating a commitment to quality and safety, manufacturers can build customer confidence and trust in their products.

    International Market Access and Trade Facilitation

    Conducting ISO 10993-23 testing can help manufacturers access international markets by ensuring that their products meet regulatory requirements.

    Innovation and Research Development Support

    ISO 10993-23 testing provides valuable information on the phototoxicity and photoallergy potential of materials. This information can be used to inform design and manufacturing decisions, driving innovation and research development.

    Environmental and Sustainability Considerations

    By reducing the risk of adverse reactions associated with phototoxicity and photoallergy, manufacturers can also reduce their environmental impact. This is achieved by minimizing the need for costly recalls and replacements.

    Conclusion

    In conclusion, ISO 10993-23 evaluation of phototoxicity and photoallergy is a critical component of medical device testing. By conducting this testing, manufacturers can ensure that their products meet regulatory requirements, identify potential risks associated with phototoxicity and photoallergy, and mitigate these risks through appropriate design and manufacturing changes. This not only ensures compliance with regulations but also provides several benefits, including competitive advantages, cost savings, and environmental sustainability.

    ISO 10993-23 Testing Services

    At Company Name, we offer comprehensive ISO 10993-23 testing services to help medical device manufacturers ensure that their products meet regulatory requirements. Our team of experts has extensive experience in evaluating the phototoxicity and photoallergy potential of materials, providing valuable insights to inform design and manufacturing decisions.

    Benefits of Working with Us

  • Expertise in ISO 10993-23 testing

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    • Get Started Today

    Contact us today to learn more about our ISO 10993-23 testing services. Our team is committed to helping medical device manufacturers ensure that their products meet regulatory requirements, while also providing several benefits, including competitive advantages, cost savings, and environmental sustainability.

    By working with us, you can:

  • Ensure compliance with regulatory requirements

  • Identify potential risks associated with phototoxicity and photoallergy

  • Mitigate these risks through appropriate design and manufacturing changes

    • Dont wait contact us today to learn more about our ISO 10993-23 testing services.

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