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Standard ID | YY/T 0614-2017 (YY/T0614-2017) | Description (Translated English) | Single-use high-pressure angiographic syringes and accessories | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C31 | Classification of International Standard | 11.040.20 | Word Count Estimation | 11,183 | Date of Issue | 2017-02-28 | Date of Implementation | 2018-01-01 | Older Standard (superseded by this standard) | YY 0614-2007 | Drafting Organization | Shandong Province, medical device product quality inspection center, Shenyang New Chi source medical supplies Co., Ltd., Wuxi City, Yushou Medical Devices Co., Ltd., Jiangsu Chen Ning Tai Medical Devices Co., Ltd. | Administrative Organization | National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106) | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 25 | Proposing organization | China Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Standard ID | YY 0614-2007 (YY0614-2007) | Description (Translated English) | Single-use high-pressure angiographic syringes and accessories | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C31 | Classification of International Standard | 11.040.20 | Word Count Estimation | 12,154 | Date of Issue | 2007-07-02 | Date of Implementation | 2008-08-01 | Quoted Standard | GB/T 1962.1; GB/T 1962.2; GB 8368; GB 15810; YY 0466 | Drafting Organization | Shenyang New Zhiyuan Medical Supplies Co., Ltd. | Administrative Organization | National Technical Committee of Standardization for medical infusion | Regulation (derived from) | Chinese industry standard filing Notice 2007 No. 9 (No. 93 overall) | Proposing organization | National Standardization Technical Committee appliances Infusion | Issuing agency(ies) | China Food and Drug Administration | Summary | This standard specifies the use of high contrast disposable syringe (hereinafter referred to angiography syringe) and accessories requirements. The primary angiographic syringe for medical departments in digital subtraction angiography (DSA), computer-controlled tomography (CT), magnetic resonance (MRI), ultrasound (US) other tests were various types of high-pressure injection equipment supporting the use. This standard does not include intravascular catheter guided puncture and related equipment requirements. |
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.
......
YY 0614-2007
Single-use high-pressure angiographic syringes and accessories
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Disposable syringes and accessories high pressure contrast
Posted 2007-07-02
2008-08-01 implementation
State Food and Drug Administration issued
Foreword
The Standard Appendix A, Appendix B and Appendix C is a normative appendix.
This standard by the National Standardization Technical Committee Infusion equipment for medical and centralized.
Drafting of this standard. Shenyang new Zhiyuan Medical Supplies Limited.
Participated in the drafting of this standard. Shenzhen Andrew Hi-Tech Industrial Co., Ltd. Wuxi-life medical equipment Limited.
The main drafters of this standard. Liu Han, Qiaowen E, Zhangwen Guo, Feng Zhong, Liu Jian.
introduction
Disposable syringe and high pressure contrast accessory (such as connecting pipe, inhalation pipe) is high-pressure injection equipment described in this standard
Supplies, transport equipment as a contrast agent, in a short time will focus on the contrast agent injected into the patient's blood vessels or organs.
With digital subtraction angiography (DSA), the control computer tomography (CT), magnetic resonance (MRI), ultrasound (US) and other diagnostic
The development of technology for imaging, scanning, imaging accuracy and success rate is rising requirements. Each device on the syringe contrast appearance
The structure, dimensions, bearing capacity have more stringent requirements. Taking into account the diversity and complexity of current and future high-pressure injection equipment, this standard
Registration does not require suitability (such as interface size, the sliding performance) angiographic syringe injection devices with special requirements.
Disposable syringes and accessories high pressure contrast
1 Scope
This standard specifies the use of disposable syringes contrast high pressure (hereinafter referred to as a contrast injector) and the requirements of Annex. The main angiographic injector
To provide the health sector during the digital subtraction angiography (DSA), the control computer tomography (CT), magnetic resonance (MRI), ultrasound
(US) and other tests, and are various types of high-pressure injection equipments.
This standard does not include a guide catheter and related equipment requirements puncture a blood vessel.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 1962.1 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 1. General requirements
(GB/T 1962.1-2001, idt ISO 594-1. 1986)
GB/T 1962.2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings
(GB/T 1962.2-2001, idt ISO 594-2.1998)
GB 8368 disposable infusion gravity infusion of formula (GB 8368-2005, ISO 8536-4.2004, MOD)
GB 15810 single-use sterile syringes (GB 15810-2001, eqv ISO 7886-1.1993)
YY 0466 medical devices for medical equipment marking, labeling, and information provided by the symbol (YY 0466-2003, ISO 15223.
2000, IDT)
3 Product Type
Figures 1 to 3 shows the common angiographic syringes and accessories (inhalation, connecting piping, etc.) schematic structure type.
Note. Figures 1 to 3 for the type just for illustrative, is not the only type of product.
1 --- syringe piston;
2 --- with a ring of the piston;
3 --- syringe jacket;
4 --- with locking means 6% luer outer cone.
Schematic diagram 1 syringe
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