YY/T 0980.2-2016 (YY/T0980.2-2016, YYT 0980.2-2016, YYT0980.2-2016)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0980.2-2016 | English | 150 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Biopsy needles for single use. Part 2: Manual biopsy needle
| Valid |
YY/T 0980.2-2016
|
Standards related to: YY/T 0980.2-2016
| 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 & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 11,141 | | 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 | | Drafting Organization | Shanghai Es Egyptian Medical Plastics Products Co., Ltd | | Administrative Organization | National Medical Syringe (needle) Standardization Technical Committee | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Proposing organization | State Administration of Food and Drug Administration | | Issuing agency(ies) | State Administration of 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. | YY/T 0980.2-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
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
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
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
Foreword
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
1 Scope
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
3.1 General
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 Positioner
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%.
5.8 Sheath
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;
Scale line
Unit. mm
Appendix A
(Informative)
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.
...
|