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Evaluation of Potential Skin Irritation Reaction Arising from Polymer Materials of Medical Devices

机译:评价医疗器械聚合物材料引起的潜在皮肤刺激反应

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摘要

The Draize skin irritation test has been employed for skin irritation tests for more than a decade. However, its accuracy has never been validated properly. Therefore, the concern about the test's predictivity and reproducibility, animal welfare groups and pressure from European regulatory authorities (e.g., the Cosmetics Directive), have prompted a search for alternative methods for testing safety of the chemicals. Skin irritancy testing is also recommended for all medical devices. The previously used Draize test and the currently employed ex vivo test were validated using pure chemical irritants, not dilute mixtures extracted from medical devices.
机译:Draize皮肤刺激性试验已用于皮肤刺激性试验已有十多年了。但是,其准确性从未得到正确验证。因此,对测试的可预测性和可重复性,动物福利团体以及来自欧洲监管机构(例如化妆品指令)的压力的关注促使人们寻求用于测试化学品安全性的替代方法。还建议对所有医疗设备进行皮肤刺激性测试。以前使用的Draize测试和当前使用的离体测试均使用纯化学刺激物而非从医疗设备中提取的稀释混合物进行了验证。

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  • 来源
    《Inside R & D》 |2013年第45期|3-3|共1页
  • 作者

    Colleen Toole;

  • 作者单位

    CeeTox Inc., 4717 Campus Drive, Kalamazoo, MI 49008;

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  • 原文格式 PDF
  • 正文语种 eng
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