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.
Basic Data
Standard ID
YY 0477-2016 (YY0477-2016)
Description (Translated English)
Rigid gas permeable contact lenses for orthokeratology
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the terms and definitions, requirements, test methods, sampling and inspection rules, marking, labeling and accompanying documentation, packaging, etc. of rigid contact lenses for orthokeratology (hereinafter referred to as orthokeratology). Orthokeratology is expected to temporarily change the shape of the cornea in order to achieve the purpose of temporary correction of refractive errors.
