This Standard specifies the terms and definitions, product classification, requirements and test methods of lens ultrasonic removal and vitrectomy device for ophthalmic surgery. This Standard is applicable to the lens ultrasonic removal device for ophthalmic surgery (hereinafter refers to device), which also possesses the vitrectomy function. NOTE. Phacofragmentation of lens indicates, in the earliest period, the surgery to use ultrasonic energy to crush (or emulsify) cataract lens, and extract lens tissues through small incision; currently, ultrasound is still the most important means for the lens removal and vitrectomy device for ophthalmic surgery; recently, there are the device using other energy and extracting cataract lens through small incision (such as laser and liquefaction); for which this Standard can be referred to.
Basic Data
Standard ID
YY 0766-2009 (YY0766-2009)
Description (Translated English)
Lens ultrasonic removal and vitrectomy devices for ophthalmic surgery
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C41
Classification of International Standard
11.040.70
Word Count Estimation
11,111
Date of Issue
2009-12-30
Date of Implementation
2011-06-01
Quoted Standard
GB 9706.1; GB 9706.15; YY/T 0644-2008; ISO 15752-2000
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the ophthalmic lens removal and vitrectomy equipment ultrasound terminology and definitions, product classification, requirements and test methods. This standard applies to the application of ultrasonic energy to perform eye surgery, cataract extraction equipment (hereinafter referred to as equipment), such devices generally function along with vitrectomy.
