This document specifies the terms and definitions, structure and basic parameters, requirements, test methods, inspection rules, marking, packaging, transportation, storage for excimer laser cornea ametropia cure system. This Standard applies to excimer laser cornea ametropia cure system (hereinafter referred to as the cure machine). The cure machine uses a 193nm excimer laser to remove corneal tissue to change the shape of the cornea to improve vision. It is mainly used for refractive keratectomy (PRK), in situ keratomileusis (LASIK) and other corneal refractive correction and therapeutic keratectomy (PTK).
Basic Data
Standard ID
YY 0599-2015 (YY0599-2015)
Description (Translated English)
Therapeutic laser equipment - Excimer laser cornea ametropia cure system
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard specifies the terms and definitions, structure and basic parameters of excimer laser corneal refractive therapy machine requirements, test methods, inspection rules, marking, packaging, transportation and storage. This Standard applies to the excimer laser corneal refractive therapy machine, therapy machine using 193 nm excimer laser to remove corneal tissue to reshape the cornea to improve vision, mainly for photorefractive keratectomy (PRK), in situ keratomileusis surgery (LASIK) and other corneal refractive surgery and therapeutic keratectomy (PTK).
