YY 0789-2010: [Including 2021XG1] Q-Switched Nd: YAG laser ophthalmic system

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Scope

This Standard specifies the basic parameters, product composition, technical requirements, test
methods, as well as marking and labeling, and packaging requirements for Q-switched Nd.
YAG laser ophthalmic system.
This Standard is applicable to Q-switched Nd. YAG laser ophthalmic system (hereinafter
referred to as ophthalmic system). The ophthalmic system is used for the incision and resection
of the anterior segment tissue through the photolysis / photo-blasting effect of the laser pulse
with a wavelength of 1,064 nm to achieve the purpose of treatment.

Basic Data

Standard ID	YY 0789-2010 (YY0789-2010)
Description (Translated English)	[Including 2021XG1] Q-Switched Nd: YAG laser ophthalmic system
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C41
Classification of International Standard	11.040.70
Word Count Estimation	10,123
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Quoted Standard	GB/T 191-2008; GB 7247.1-2001; GB 9706.1-2007; GB 9706.20-2000; GB/T 14710-2009; YY 0065-2007
Regulation (derived from)	State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the Q-switched Nd: YAG laser eye treatment for the basic parameters and product composition, technical requirements, test methods, and signs labeling, packaging and other requirements. This standard applies to Q-switched Nd: YAG laser eye treatment machine (hereinafter referred to as the treatment machine). Treatment machine via a wavelength of 1064nm laser pulse photolysis of human tissue/light-induced blast effect, for the anterior segment incision and excision of the organization in order to achieve therapeutic purposes.