1
关注
1290
浏览

changingthe center thickness of soft contact lenses?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

si4520 一阶会员 用户来自于: 广东省深圳市
2023-09-18 20:01

Yes. The oxygen permeation properties of soft contactlenses include two indexes: oxygen permeability Dk and oxygentransmissibility Dk/t, and the latter is directly related to the thicknessof the lens. Therefore, when changing the center thickness of the lens,the manufacturer should consider the effect of the change in thicknesson properties of the lens to note whether the change in thickness hasled to changed nominal value of the oxygen transmissibility Dk/t.If it is necessary to modify such nominal value, the administrativecounterpart should submit corresponding test report as supporting data,as well as the basis for determining such nominal value of oxygentransmissibility Dk/t. Meanwhile, the relevant risk analysis should beconducted and verification data should be provided as needed.


关于作者

问题动态

发布时间
2023-09-18 20:01
更新时间
2023-09-18 20:01
关注人数
1 人关注

推荐内容

球囊扩张导管产品技术要求中额定爆破压指标应如何制定?
《医疗器械注册自检管理规定》中委托检验有哪些规定?
以免疫层析法为检验原理的定性体外诊断试剂进行精密度研究时有哪些考量因素?
第二类有源医疗器械临床试验若采用平行对照设计,选择对照产品应遵循什么原则?
标准变更同一个注册单元的有源产品,医用注射泵,外观长相不一样,功能相似,关键部件来自同一家,比如电机,电池,开关电源来自同一 以找一台功能最全的检验,其他的做典型性型号覆盖评价就可以?
通过eRPS 系统进行电子申报的事项如何查询 申报进度?
2021年申报的首次注册项目,目前在补正材料过程中,是否需要按照新发布的《定量检测体外诊断试剂分析性能评估注册审查指导原则》的要求补正分析性能评估资料?
电子内窥镜如何划分注册单元?
临床检验设备变更需要提交临床评价资料,属于免临床试验的产品其临床评价路径有推荐吗,是否是同品种的进行对比分析即可?
is it possible to register thehost and consumables together in the name of company A?