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首页> 外文期刊>Eye & contact lens >Proposed silicone hydrogel contact lens grouping system for lens care product compatibility testing
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Proposed silicone hydrogel contact lens grouping system for lens care product compatibility testing

机译：拟议的有机硅水凝胶隐形眼镜分组系统，用于镜片护理产品兼容性测试

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摘要

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health is charged with ensuring that medical devices on the market are safe and effective. Center for Devices and Radiological Health evaluates contact lenses (CLs) and CL care products before they enter the marketplace and monitors them once on the market for continued safety and effectiveness. One element of the FDA's premarket review process is to ensure that CLs and their care products are compatible with one another. Although the only definite way to determine if any potentially harmful interactions exist between a given care product and a lens is to test every lens on the market with the care product, this approach is burdensome and impractical in the current mature CL market. As an alternative, Stone proposed that CLs with similar chemical properties be grouped and 1 representative lens from each group be used for lens-care product interaction testing.
机译：美国食品和药物管理局（FDA）设备与放射卫生中心负责确保市场上的医疗设备安全有效。设备和放射卫生中心会在隐形眼镜（CL）和CL护理产品进入市场之前对其进行评估，并在市场上对其进行一次监控以确保持续的安全性和有效性。 FDA上市前审查程序的一个要素是确保CL和它们的护理产品相互兼容。尽管确定给定的护理产品和镜片之间是否存在任何潜在有害相互作用的唯一确定方法是使用该护理产品测试市场上的每个镜片，但是这种方法在当前成熟的CL市场上是繁重且不切实际的。作为替代方案，Stone建议将化学性质相似的CL进行分组，并将每组中的1个代表性镜片用于镜片护理产品的相互作用测试。

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