YY 0477-2016: Translated English of Chinese Standard. YY0477-2016: Rigid gas permeable contact lenses for orthokeratology
https://www.chinesestandard.net, 2017 M09 2 - 14 pages
This Standard specifies the terms and definitions, requirements, test methods, sampling and inspection rules, marks, labels and accompanying data, packaging for rigid gas permeable contact lenses for orthokeratology (hereinafter referred to as orthokeratology lenses). Orthokeratology lenses are expected to be used by temporarily altering corneal morphology in order to achieve temporary correction of refractive errors.
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Sampling and inspection rules
Marks labels and accompanying information
accompanying information accompanying technical documentation achieve temporary correction aide curve zone alignment curve zone applicable base curve zone batch biocompatibility evaluation characteristic peak complex reverse geometry Contact angle cornea corneal morphology curve zone rear cylinder deformation deleted Annex Exit-factory inspection gas permeable contact GB/T Geometric parameter inspection items inspection rules lenses for orthokeratology lenses shall comply main chemical molecular manufacturer shall provide marked according materials for orthokeratology Medical devices microbiological requirements nominal value optometrists orthokeratology lenses provided orthokeratology lenses reaches oxygen permeability coefficient packaging container’s label patient permeable contact lenses radiation aging test radius of curvature rear cambered surface rear vertex refractive error Refractive index release of preservatives reverse curve curvature reverse curve zone reverse geometry design rigid gas permeable small packaging container’s specified Standard surface of orthokeratology Terms and definitions test methods testing sample tolerance total diameter type inspection vector height warning mark wear without prescription YY/T