YY/T 0980.4-2016 (YY/T0980.4-2016, YYT 0980.4-2016, YYT0980.4-2016) & related versions
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Biopsy needles for single use. Part 4: Mechanical complete type
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YY/T 0980.4-2016
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YYT 0980.4-2016
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YY/T 0980.4-2016: PDF in English (YYT 0980.4-2016)
YY/T 0980.4-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Biopsy needles for single use -
Part 4. Mechanical complete type
ISSUED ON. JULY 29, 2016
IMPLEMENTED ON. JUNE 1, 2017
Issued by. China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically &
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Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Structure type... 5
4 Material ... 7
6 Packaging and marking ... 9
7 Instructions for use ... 9
8 Transportation and storage ... 10
9 Type inspection rules ... 10
Annex A (informative) Type inspection rules ... 11
Bibliography ... 12
Foreword
YY/T 0980 “Biopsy needles for single use” series of standards consist of the following
parts.
- Part 1. General requirements;
- Part 2. Manual biopsy needle;
- Part 3. Mechanical assembly type
- Part 4. Mechanical complete type.
This Part is Part 4 of YY/T 0980 “Biopsy needles for single use”.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. Issuing organizations of this document shall not be held
responsible for identifying any or all such patent rights.
This Part is proposed by China Food and Drug Administration.
This Part is under the jurisdiction of National Technical Committee on Medical Syringe
(Needle) of Standardization Administration of China (SAC/TC 95).
Main drafting organizations of this Part. Zhejiang Fert Medical Device Co., Ltd.,
Shanghai Testing & Inspection Institute for Medical Devices, Shanghai SA Medical &
Plastic Instruments Co., Ltd.
Main drafters of this Part. Su Weidong, Wang Zewei, Cao Xianming.
Introduction
This Part of YY/T 0980 specifies the requirements for mechanical complete type biopsy
needles for single use.
This Part does not provide requirements and methods for sampling performance and
ultrasonic development, because currently there is no suitable test methods and
simulation test materials.
In view of the fact that the structure type of mechanical complete type biopsy needles
and the location, depth, state, texture and method of the puncture are different, this
Part does not specify the puncture force. However, manufacturers are encouraged to
determine appropriate puncture force by verifying, combining the specific structure and
use of the mechanical complete type biopsy needle produced by each of the
manufacturers.
In view of the fact that the trigger device of mechanical complete type biopsy needles
may be mistakenly triggered in the course of clinical use, and there is no suitable test
method for trigger devices, this Part does not specify the trigger device. However,
manufacturers are encouraged to determine appropriate trigger device data and test
method by verifying.
Biopsy needles for single use -
Part 4. Mechanical complete type
1 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.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 1220 Stainless steel bar
GB/T 2965 Titanium and titanium alloy bar
YY/T 0980.1-2016 Biopsy needles for single use - Part 1. General requirements
3 Structure type
3.1 A biopsy needle consists of an outer needle tube, an inner needle bar, a protective
cover and a mechanical power device.
NOTE. Biopsy needles can be used with guide needles, cursors, etc. when necessary.
a) product name;
b) product model description;
c) product performance, main structure;
d) scope;
e) use methods and precautions;
f) storage conditions;
g) other instructions and necessary warnings.
8 Transportation and storage
8.1 During transportation and storage process, biopsy needles shall be prevented from
stress, sun and rain and snow.
8.2 Biopsy needles shall be stored in a non-corrosive-gas, well ventilated and clean
environment.
9 Type inspection rules
See Annex A for type inspection rules.
Bibliography
[1] GB 15811-2001 Sterile hypodermic needles for single use
[2] YY 0321.2-2009 Single-use needle for anaesthesia
[3] YY/T 0313-2014 Medical polymer products - Requirement for package and
information supplied by manufacturer
[4] YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements
......
| 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 & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Word Count Estimation | 10,118 | | 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) | | Proposing organization | State Administration of Food and Drug Administration | | Issuing agency(ies) | State Administration of 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. |
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