YY/T 0614-2017 PDF in English
YY/T 0614-2017 (YY/T0614-2017, YYT 0614-2017, YYT0614-2017)
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Single-use high-pressure angiographic syringes and accessories
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| YY 0614-2007 | English | 479 |
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Single-use high-pressure angiographic syringes and accessories
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Standards related to (historical): YY/T 0614-2017
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YY/T 0614-2017: PDF in English (YYT 0614-2017) YY/T 0614-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY/T 0614-2007
Single-use high-pressure
angiographic syringes and accessories
ISSUED ON. FEBRUARY 28, 2017
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of contents
Foreword . 3
Introduction .. 5
1 Scope .. 6
2 Normative references . 6
3 Product type . 7
4 Product marking . 8
5 Materials . 9
6 Physical requirements . 9
7 Chemical requirements . 12
8 Biological requirements . 12
9 Markings . 12
10 Packaging . 14
Appendix A (Normative) Adhesion test . 15
Appendix B (Normative) Chemical performance test solution preparation
method . 17
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0614-2007 “Single-use high-pressure
angiographic syringes and accessories”. As compared with YY/T 0614-2007, in
addition to editorial changes, the main technical changes of this standard are
as follows.
- ADD the 88 kPa negative pressure adhesion requirements of the
angiographic syringe;
- MODIFY the cork piercer requirements;
- MODIFY the air intake device requirements;
- ADD anti-reflux valve requirements and test methods;
- REVISE the adhesion test method;
- ADD a single package identifier;
- ADD a shelf package or multi-unit packaging identifier;
- DELETE the Appendix A Particle content determination method from the
original standard, the particle content determination method makes
reference to the test method as given in YY/T 1556-2017 Test methods for
particle contamination of infusion, transfusion and injection equipment for
medical use which is formulated at the period;
- MODIFY the chemical test solution preparation method.
Please note that some of the contents of this document may involve patents.
The issuing agency of this document does not assume responsibility for
identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard shall be under the jurisdiction of the National Standardization
Technical Committee for Medical Infusion Devices (SAC/TC 106).
Drafting organizations of this standard. Shandong Medical Device Product
Quality Inspection Center, Shenyang Xinzhiyuan Medical Products Co., Ltd.,
Wuxi Yushou Medical Devices Co., Ltd., Jiangsu Guoyu Ningtai Medical
Devices Co., Ltd.
Single-use high-pressure
angiographic syringes and accessories
1 Scope
This standard specifies the requirements for the single-use high-pressure
angiographic syringes and accessories (hereinafter referred to as angiographic
syringes). The angiographic syringe is mainly used by the medical department
to perform digital subtraction angiography (DSA), computer-controlled
tomography (CT), magnetic resonance imaging (MRI), and ultrasound (US)
examinations, together with various types of high-pressure injection device.
This standard does not include requirements for endovascular catheters and
related guidance puncture devices.
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 standard.
GB/T 1962.1 Conical fittings with a 6%(Luer) taper for syringes, needles and
certain other medical equipment - Part 1. General requirement
GB/T 1962.2 Conical fittings with a 6%(Luer) taper for syringes, needles and
certain other medical equipment - Part 2. Lock fittings
GB 15810 Sterile hypodermic syringes for single use
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
YY 0585.4-2009 Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 4. Check valves
YY 0804-2010 Transfer sets for pharmaceutical preparations -
Requirements and test methods
For angiographic syringes and accessories intended for use under non-clean
conditions, the design shall be such that the contrast agent is always in isolation
from the outside world during normal use.
6.1.4 6% Luer cone joint
The conical joint for angiographic syringes and accessories shall meet the
following requirements.
- Cone fitting that complies with GB/T 1962.1 or GB/T 1962.2;
- If the angiographic syringe uses an outer cone joint which complies with
GB/T1962.1, it shall be equipped with a special locking device that can
match with the internal cone joint that meets GB/T 1962.2.
6.1.5 Particle contamination
Angiographic syringes and accessories shall be manufactured with minimal
particulate contamination. The liquid access surface shall be smooth and clean.
When the syringe is connected to the tubing and/or the inhaler (when the liquid
is drawn into the angiographic syringe, the liquid passes through the inhaler,
and when the liquid is expelled from the angiographic syringe, the liquid is
passed through the connection tubing), and tested i accordance with YY/T
1556-2017, the particulate contamination index shall not exceed 90.
6.2 Angiographic syringe additional requirements
6.2.1 Lubricants
The inner surface of the angiographic syringe jacket and the outer surface of
the plunger shall have no lubricant accumulation.
6.2.2 Transparency
The angiographic syringe jacket shall have sufficient transparency.
6.2.3 Scale and mark
If there are scales and marks on the angiographic syringe, the scale lines and
marks shall be complete and clear.
6.2.4 Cone joint inner diameter
The inner hole diameter of the Luer outer cone joint on the angiographic syringe
shall not be less than 1.2 mm.
6.2.5 Adhesion
Note 2. The symbol 2725 of ISO 7000 can be used to indicate the
existence of a certain substance of interest, by replacing the “x” with the
abbreviation of the substance. If no substance of interest is observed, the
symbol “x” is drawn.
f) Lot number or production date, beginning with “batch” or “LOT”, or using
graphic symbols given in YY/T 0466.1-2009;
g) Expiration date, with appropriate text, or use of graphic symbols given in
YY/T 0466.1-2009;
h) The name and address of the manufacturer and/or distributor;
i) Recommended use environment (if necessary).
9.2 Shelf packaging or multiple-unit packaging
The shelf packaging or multi-unit packaging (if used) shall have at least the
following information.
a) Text description of contents;
b) Quantity;
c) Use of graphic symbols given in YY/T 0466.1-2009 or equivalent text
description to indicate asepsis;
d) Lot number or production date, beginning with “batch” or “LOT”, or using
graphic symbols given in YY/T 0466.1-2009;
e) Expiration date, with appropriate text, or use of graphic symbols given in
YY/T 0466.1-2009;
f) The name and address of the manufacturer and/or distributor;
g) Recommended storage conditions (if any);
h) Models of suitable injection equipment;
i) Recommended use environment (if necessary).
Note. The symbol 2725 of ISO 7000 can be used to indicate the presence of a
certain substance of interest, by replacing the “×××” with the abbreviation of the
substance. If not containing the substance of interest, the symbol “x” is drawn
on it.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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