YY/T 0980.4-2016: Biopsy needles for single use - Part 4: Mechanical complete type

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Scope

This Part of YY/T 0980 specifies the requirements for biopsy needles for single use -
mechanical complete type (hereinafter referred to as “biopsy needles”).
This Part applies to mechanical complete type biopsy needles for single use, of which
the needle for single use and the mechanical power device are assembled together at
the time of manufacture; the mechanical power device is for automatic or semi-
automatic cutting operations to collect biopsy samples.

Basic Data

Standard ID	YY/T 0980.4-2016 (YY/T0980.4-2016)
Description (Translated English)	Biopsy needles for single use - Part 4: Mechanical complete type
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Word Count Estimation	10,114
Date of Issue	2016-07-29
Date of Implementation	2017-06-01
Quoted Standard	GB/T 1220; GB/T 2965; YY/T 0980.1-2016
Regulation (derived from)	State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the requirement for a one-time use of a biopsy needle - a motorized (hereinafter referred to as "biopsy needle"). This standard applies to disposable needle body and mechanical power device is manufactured at the time of manufacture is integrated, the use of mechanical power device for automatic or semi-automatic cutting operation to collect live tissue samples of the one-time use of mobile single biopsy needle.