YY/T 0980.2-2016 English PDF (YYT0980.2-2016)
YY/T 0980.2-2016 English PDF (YYT0980.2-2016)
YY/T 0980.2-2016: Biopsy needles for single use. Part 2: Manual biopsy needle
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Biopsy needles for single use –
Part 2. Manual biopsy needle
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Classification ... 5
4 Materials ... 9
5 Requirements ... 10
6 Packaging and marking ... 12
7 Instructions for use... 12
8 Transportation and storage ... 13
9 Type inspection rules ... 13
Appendix A (Informative) Type inspection rules ... 14
Bibliography ... 15
YY/T 0980 Biopsy Needles for Single Use can be divided into 4 parts.
--- Part 1. General Requirements;
--- Part 2. Manual Biopsy Needle;
--- Part 3. Mechanical Assembly Type;
--- Part 4. Mechanical Complete Type.
This part belongs to Part 2 of YY/T 0980.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
Please note that some contents of this document may involve patents. The issuer of this document doesn’t assume the responsibility for identifying these patents. This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee for Standardization of Medical Syringe (Needle) (SAC/TC 95).
Drafting organizations of this Part. Shanghai SA Medical & Plastic Instruments Co., Ltd., Shanghai Testing & Inspection Institute for Medical Devices, Zhejiang Fert Medical Device Co., Ltd., and Zhejiang Kindly Medical Devices Co., Ltd. Chief drafting staffs of this Part. Cao Xianming, Wang Zewei, and Su Weidong. Introduction
This Part doesn’t provide the requirements and methods for sampling performance and ultrasound imaging; because currently there is no suitable test methods and simulation test materials.
In view of that the structure of manual biopsy needle and the location, depth, state, texture, method of puncture are different, this Part does not provide the puncture force. However, manufacturers are encouraged to determine the appropriate puncture force through verification combining the specific structure and use of the manual biopsy needle produced by each manufacturer.
Since the application specifications of biopsy needle has exceeded the specification range corresponding to color coding for identification stipulated in YY/T 0296 and ISO 6009, the requirement for use color coding is not specified.
Biopsy Needles for Single Use –
Part 2. Manual Biopsy Needle
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.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document.
GB/T 1220 Stainless Steel Bars
GB/T 2965 Titanium and Titanium Alloy Bars
YY/T 0980.1-2016 Biopsy Needles for Single Use – Part 1. General Requirements 3 Classification
The structures of the biopsy needles can be divided into manual aspiration, manual cutting, and combination of the former two types.
NOTE. if necessary, the biopsy needle can coordinate with aspirator, guide needle, sampling tube, root plug, Vernier, localizing guide wire, etc. for use.
Figure 4 -- Biopsy Needle’s External Needle
Typical Millimeter Scale Line Schematic Diagram
5.7.1 If the biopsy needle is equipped with the puncture depth positioner, when exerting 10N axial static pressure on the front end of the positioner, last for 10s, the positioner shall have no axial movement.
5.7.2 If the depth positioner has the depth meter, it shall have the numerical and scale display, and shall be clearly visible. When moving it to any two depth scales within the marking range, measuring the distance between front end of positioner and needlepoint top by common measuring gauge, the corresponding mark deviation shall be within the range of ±5%.
The sheath for protecting the needlepoint shall be equipped with out of the needlepoint of the biopsy needle, and the sheath shall not fall off naturally.
6 Packaging and marking
The packaging and marking of the biopsy needle shall meet the requirements of Clause 6 and 7 of YY/T 0980.1-2016.
7 Instructions for use
The instructions for use shall contain the following contents at least. a) Product name;
b) Medical device manufacturer license number, product registration number and implement standard number;
c) Product model instruction;
Type inspection rules
A.1 Inspection items
The inspection items can refer to the requirements of Clause 5.
A.2 Sampling amount
Physical performance shall randomly sample 10 pieces; while the chemical and biological performance shall sample as per the demand.
A.3 Judgement rules
When all inspection items are qualified, the product passes through the type inspection. During the inspecting process, if the chemical and biological performances are qualified, but the physical performance is disqualified, the sampling amount is allowed to be doubled, and re-inspect the disqualified item. If the re-inspection is still disqualified, then the product doesn’t pass through the type inspection.