This Part specifies the requirements of biopsy needles for single use – manual type (hereinafter referred to as biopsy needle). This Part is applicable to the manual-type biopsy needle for single use that manually finishes collecting the living sample of soft tissue, bone tissue for the test. This Part is also applicable to the manual-type biopsy needle for single use that coordinates with endoscope for use. This Part is not applicable to the manual-type biopsy needle for repeated use, mechanical assembly type biopsy needle for repeated or single use, or mechanical complete type biopsy needle.
Basic Data
Standard ID
YY/T 0980.2-2016 (YY/T0980.2-2016)
Description (Translated English)
Biopsy needles for single use - Part 2: Manual biopsy needle
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.040.20
Word Count Estimation
11,131
Date of Issue
2016-01-26
Date of Implementation
2017-01-01
Quoted Standard
GB/T 1220; GB/T 2965; YY/T 0980.1-2006
Regulation (derived from)
China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies a one-time use of biopsy needle - manual (hereinafter referred to as biopsy needle) requirements. This standard applies to the manual operation to complete the human body soft tissue, bone tissue collection of live samples for inspection with a one-time use of manual biopsy needle. Also suitable for use with the endoscope with a one-time use of manual biopsy needle. This standard does not apply to repetitive manual biopsy needles and reusable or disposable motorized biopsy needles and motorized biopsy needles.
