This Part of YY/T 0980 specifies the requirements for biopsy needles for single use - mechanical assembly type (hereinafter referred to as “biopsy needles”). This Part applies to mechanical assembly type biopsy needles for single use, which consist of needles for single use and reusable mechanical power devices for automatic or semi-automatic cutting operations to collect biopsy samples. This Part does not apply to reusable biopsy needles and mechanical power devices connected with the biopsy needle by means of assembly before use.
Basic Data
Standard ID
YY/T 0980.3-2016 (YY/T0980.3-2016)
Description (Translated English)
Biopsy needles for single use - Part 3: Mechanical assembly type
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Word Count Estimation
10,149
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 requirements for a one-time use of a biopsy needle - a motorized assembly (hereinafter referred to as a "biopsy needle"). This standard applies to disposable needle body and reusable mechanical power devices assembled together, with mechanical power device for automatic or semi-automatic cutting operation to collect live tissue samples of the disposable use of motorized biopsy needle. This standard does not apply to reusable biopsy needles and mechanical power devices that are connected to the biopsy needle by means of assembly.
