1 回答
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.
