YY/T 0891-2013 (YY/T0891-2013, YYT 0891-2013, YYT0891-2013)
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Particular specifications for angiographic injector
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YY/T 0891-2013
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Standards related to: YY/T 0891-2013
| Standard ID | YY/T 0891-2013 (YY/T0891-2013) | | Description (Translated English) | Particular specifications for angiographic injector | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 8,811 | | Quoted Standard | GB 9706.1-2007; GB 9706.15-2008; GB/T 10149-1988; GB/T 14710-2009 | | Drafting Organization | Liaoning Province Medical Device Testing | | Administrative Organization | National Standardization Technical Committee medical electrical equipment and medical X-ray equipment Standardization Technical Committee | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the angiographic high-pressure injection system (hereinafter referred to as "high-pressure injection device") terms and definitions, composition, requirements and test methods. This standard applies to the high-pressure injection d | YY/T 0891-2013
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Particular specifications
for angiographic injector
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Composition ... 6
5 Requirements... 6
6 Test methods ... 8
Foreword
This Standard 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. The issuing organization of this document shall not be
held responsible for identifying any or all such patent rights.
This Standard is proposed by China Food and Drug Administration.
This Standard is under the jurisdiction of Subcommittee on Medical X-ray Equipment
and Appliances of National Technical Committee on Medical Electrical Equipment of
Standardization of Administration of China (SAC/TC 10/SC 1).
Drafting organizations of this Standard. Liaoning Medical Device Test Institute,
Shenzhen Seacrown Electromechanical Co., Ltd., Shenzhen Anke High-tech Co., Ltd.
Drafters of this Standard. Jin Yubo, Zhong Dingsu, Yin Haibo.
Particular specifications for angiographic injector
1 Scope
This Standard specifies terms and definitions, composition, requirements and test
methods for angiographic injectors (hereinafter referred to as “injectors”).
This Standard applies to angiography injectors.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the dated edition cited applies. For undated
references, the latest edition of the referenced document (including all amendments)
applies.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for
safety
GB 9706.15-2008 Medical electrical equipment - Part 1. General requirements for
safety - 1. Collateral standard. Safety requirements for medical electrical systems
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB/T 14710-2009 The environmental requirement and test methods for medical
electrical equipment
3 Terms and definitions
For the purpose of this document, the following terms and definitions and those defined
in GB/T 10149 apply.
3.1
angiographic injector
The injector used to rapidly inject a sufficient amount of contrast agent to the inspection
site in a certain period of time, in the diagnosis or treatment of vascular intervention
angiography, in order to obtain the required medical image with the use of X-ray
angiography equipment.
3.2
injector head
The part equipped with injection push mechanism and supporting syringe.
3.3
flow rate
The dosage of the contrast agent injected per unit of time, in milliliters per second
(mL/s).
3.4
rise time
The time taken from the start of the injection to when it reaches the set flow rate, in
seconds.
3.5
maximum injection pressure
The maximum pressure that can be reached at the time of injection of an injector.
3.6
pressure limit
The maximum allowable pressure during injection of an injector.
3.7
injection delay
After receiving the start signal, the injector starts the injection after a set delay time.
3.8
X-ray delay
After pressing the injection switch, the injector sends out the trigger signal after a set
delay time.
3.9
fill rate
b) power supply frequency. 50 Hz ± 1 Hz.
6.2 Flow rate
The test medium is distilled or deionized water. The injection dose is set to 100 mL,
and the flow rate is set to the minimum value and 50 % of the maximum value
respectively. When it is set to the maximum value, use a timer (such as synchronized
stopwatch) to count the time taken from the start to the end of the injection, use a
balance to weigh the distilled water and convert it to capacity, calculate the flow rate
deviation, which shall meet the requirements of 5.2.
6.3 Injection dose
The test medium is distilled or deionized water. SET the injection dose to 2 mL (when
the flow rate is the minimum value), 20 mL (when the flow rate is 50 % of the maximum
value) and 40 mL (when the flow rate is the maximum value); USE a balance to weigh
the distilled water and convert it to capacity; CALCULATE the injection dose deviation,
which shall meet the requirements of 5.3.
6.4 Fill rate
The test medium is distilled or deionized water. USE a timer to count the time taken
from the start to the end of the filling signal; DETERMINE the capacity of the filled
injection agent by weighing the weight of the container before and after filling;
CALCULATE the fill rate, which shall meet the requirements of 5.4.
6.5 Maximum injection pressure
SET the pressure limit to the maximum value of the injector; USE a connector to
connect the syringe and the pressure gauge; INJECT in a flow rate of 3 mL/s; READ
the pressure the injector indicates when it exceeds the pressure limit and stops the
injection; CALCULATE the deviation between the actual pressure and the maximum
injection pressure, which shall meet the requirements of 5.5.
6.6 Pressure limit
SET the pressure limit to 20 % of the maximum injection pressure (or near value) and
80 % of the maximum injection pressure (or near value) respectively; USE a tee
connector to connect the syringe, the pressure gauge and the catheter; INJECT in a
flow rate of 3 mL/s; READ the pressure the injector indicates when it exceeds the
pressure limit and stops the injection; CALCULATE the deviation between the actual
pressure and the set pressure, which shall meet the requirements of 5.5.
6.7 Injection delay
SET the delay time to 3 s; USE a timer to count the time taken from receiving the signal
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