YY/T 0891-2013 PDF English
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| YY/T 0891-2013 | English | 150 |
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Particular specifications for angiographic injector
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YY/T 0891-2013: Particular specifications for angiographic injector---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0891-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
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
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.
4 Composition
The injector consists of at least a push and control system, a supporting and fixing part,
accessories, etc.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified, the working conditions of the injector shall meet.
5.1.2 Power supply conditions
The power supply conditions of the injector shall meet.
5.2 Flow rate
The flow rate range of injectors for hearts and large vessels shall not be less than 1.0
mL/s to 30 mL/s. When the flow rate is less than or equal to 15 mL/s, the deviation
shall not be greater than ±5 %; when the flow rate is greater than 15 mL/s, the deviation
shall not be greater than ±10 %.
5.4 Fill rate
The fill rate of injectors shall be specified in the product standard, the deviation shall
not be greater than ±5 %.
5.5 Maximum injection pressure
The maximum injection pressure of injectors for hearts and large vessels shall not be
less than 6.89 MPa (1000 psi).
5.6 Pressure limit
The device shall be capable of setting the pressure limit during injection. When the
pressure limit is less than or equal to 4.13 MPa (600 psi), the deviation shall not exceed
±0.34 MPa (50 psi); when the pressure limit is greater than 4.13 MPa (600 psi), the
deviation shall not exceed ±0.48 MPa (70 psi).
5.9 Rise time
The setting range of the rise time should be specified in the product standard.
5.10 Rotation angle of injector head
The angle between the upward injector head and the horizontal plane shall not be less
than 60°, and the angle between the downward injector head and the horizontal plane
shall not be less than 10°.
5.11 Functions
The injector shall have the following functions.
5.12 Appearance
It shall meet the following requirements.
5.14 Security
It shall meet the requirements of GB 9706.1-2007 and GB 9706.15-2008.
6 Test methods
6.1 Working conditions
6.1.1 Environmental conditions
It shall comply with the specifications of 5.1.1.
6.1.2 Power supply conditions
The power supply conditions are as follows.
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.
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.
6.6 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
to starting the injection; CALCULATE the injection delay deviation, which shall meet
the requirements of 5.7.
6.9 Rise time
Actual operation, which shall meet the requirements of 5.9.
6.10 Rotation angle of injector head
Actual operation, measured with a goniometer.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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