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iso-10993-23-assessment-of-uv-induced-phototoxicity
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ISO 10993-23 Assessment of UV-induced Phototoxicity Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The ISO 10993-23 Assessment of UV-induced Phototoxicity testing service is governed by a set of international and national standards that ensure the safety and efficacy of medical devices, including those exposed to ultraviolet (UV) radiation. The relevant standards include:

  • ISO 10993: Medical devices Biological evaluation of medical devices

    • Part 1: Evaluation and testing within a risk management process

    Part 23: Assessment of UV-induced phototoxicity

  • ASTM F963-18: Standard Consumer Safety Specification for Toy Safety

  • EN ISO 10993-5: Biological evaluation of medical devices Tests for in vitro cytotoxicity

  • TSE EN ISO 10993-23: Evaluation of the biological properties of medical devices

    • These standards are developed and maintained by standard development organizations (SDOs) such as:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • CEN (European Committee for Standardization)

  • TÜV Rheinland (Deutsche Akkreditierungsstelle)

    • These organizations ensure that standards evolve to reflect the latest scientific knowledge, technological advancements, and regulatory requirements.

    Standard Requirements and Needs

    The ISO 10993-23 Assessment of UV-induced Phototoxicity testing is necessary to evaluate the phototoxic potential of medical devices exposed to UV radiation. This test helps to:

  • Assess safety: Evaluate the risk of phototoxic reactions in patients

  • Comply with regulations: Meet international and national regulatory requirements for medical device safety

  • Ensure efficacy: Verify that devices function as intended without causing harm

    • Consequences of not performing this test include:

  • Injury or death: Phototoxic reactions can cause serious harm to patients

  • Regulatory non-compliance: Failure to meet regulatory standards can result in product recalls, fines, and damage to reputation

  • Loss of market access: Companies that fail to comply with safety regulations may be prohibited from selling their products in certain markets

    • The industries and sectors that require this testing include:

  • Medical devices (e.g., implants, surgical instruments)

  • Cosmetics and personal care products (e.g., sunscreens, skin creams)

  • Pharmaceuticals (e.g., UV-activated treatments)

    • Test Conditions and Methodology

    The ISO 10993-23 Assessment of UV-induced Phototoxicity test involves the following steps:

    1. Sample preparation: Prepare the device or product for testing

    2. UV exposure: Expose the sample to controlled levels of UV radiation

    3. Cell culture: Perform cell culture tests using human skin cells (e.g., keratinocytes, fibroblasts)

    4. Measurement and analysis: Measure and analyze the effects of UV exposure on cell viability, DNA damage, and other endpoints

    The testing equipment and instruments used include:

  • UV lamp or LED system

  • Cell culture incubators and microscopes

  • Spectrophotometers and fluorescence microscopy systems

    • Test Reporting and Documentation

    The test report includes:

  • Summary: Summary of the testing protocol, results, and conclusions

  • Raw data: Raw data from the cell culture tests

  • Processed data: Processed data, including statistical analysis and graphs

  • Certification: Accreditation and certification details

    • Why This Test Should Be Performed

    Performing the ISO 10993-23 Assessment of UV-induced Phototoxicity testing offers numerous benefits:

  • Risk assessment and mitigation: Evaluate the phototoxic potential of devices and mitigate risks

  • Quality assurance and compliance: Ensure regulatory compliance and product safety

  • Competitive advantages: Distinguish your products from competitors by demonstrating commitment to safety

  • Cost savings and efficiency improvements: Avoid costly recalls, fines, and reputational damage

    • Why Eurolab Should Provide This Service

    Eurolab is a leading laboratory testing service provider with expertise in:

  • UV-induced phototoxicity testing

  • Biological evaluation of medical devices

  • Cell culture and cytotoxicity testing

  • Material characterization and analysis

    • Our state-of-the-art equipment, qualified personnel, and accreditation ensure that our services meet international standards. We offer:

  • Expertise: Our team has extensive experience in laboratory testing and regulatory compliance

  • Equipment: State-of-the-art facilities and instruments for precise and accurate results

  • Certification: Accreditation to national and international standards (e.g., ISO 17025, ENAC)

  • Quality management systems: ISO 9001:2015 compliant quality management system

  • Customer service and support: Dedicated customer support team

    • Eurolab is committed to providing reliable, accurate, and timely results that meet the highest industry standards.

    Additional Requirements

    To ensure compliance with regulatory requirements and industry standards, please note:

  • Sampling frequency: Sampling must be performed in accordance with ISO 10993-23

  • Cell culture conditions: Cell culture tests must be conducted under controlled conditions (e.g., temperature, humidity)

  • UV exposure levels: UV exposure levels must meet the specified criteria for testing

    • By following these guidelines and requirements, you can ensure that your products meet regulatory standards and provide safe and effective solutions to patients.

    Conclusion

    The ISO 10993-23 Assessment of UV-induced Phototoxicity testing is a critical step in evaluating the safety and efficacy of medical devices exposed to UV radiation. By understanding the standard-related information, requirements, and testing methodology, you can ensure compliance with regulatory standards and mitigate risks associated with phototoxic reactions.

    Eurolab is committed to providing expert laboratory testing services that meet international standards. Contact us today to discuss your testing needs and ensure that your products are safe for patients and compliant with regulatory requirements.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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