YY/T 1601-2018: Ultrasonic surgical equipment for osseous tissue

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Scope

This Standard specifies technical requirements, test methods, inspection rules,
marks and user's manual for ultrasonic surgical equipment for osseous tissue
(hereinafter referred to as the equipment).
This Standard is applicable to ultrasonic surgical equipment for osseous tissue.
This Standard is not applicable to ultrasonic tooth cleaning device for removing
plaque and stones on teeth.

Basic Data

Standard ID	YY/T 1601-2018 (YY/T1601-2018)
Description (Translated English)	Ultrasonic surgical equipment for osseous tissue
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C41
Classification of International Standard	11.040.60
Word Count Estimation	8,823
Date of Issue	2018-01-19
Date of Implementation	2019-01-01
Quoted Standard	GB/T 191-2008; GB 9706.1-2007; GB/T 9969-2008; GB/T 14710-2009; YY/T 0644-2008
Regulation (derived from)	China Food and Drug Administration announced No. 8 of 2018
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the technical requirements, test methods, inspection rules, markings and operating instructions for ultrasonic bone surgery equipment (hereinafter referred to as equipment). This standard applies to ultrasound bone tissue surgery equipment. This standard does not apply to ultrasonic scaling devices that remove plaque and stones from teeth.