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YY/T 0891-2013: Particular specifications for angiographic injector
YY/T 0891-2013
Particular specifications for angiographic injector
ICS 11.040.50
C43
Pharmaceutical industry standards People's Republic of China
Conditions for special high-pressure injection apparatus angiography
Published 2013-10-21
2014-10-01 implementation
China Food and Drug Administration issued
Foreword
This standard was drafted in accordance with rules GB/T 1.1-2009 given.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume responsibility to identify these patents.
The standard proposed by the State Administration of Food and Drug Administration.
This standard by the National Medical X-ray apparatus for medical appliances and utensils Standardization Committee Standardization Technical Committee (SAC/TC10/SC1) centralized.
This standard was drafted. Medical Device Testing Liaoning Province, Shenzhen City letter crown Electrical Co., Ltd., Shenzhen Anke High-tech Co., Ltd.
This standard drafter. Jinyu Bo, Su tripods, silver Hyperion.
Conditions for special high-pressure injection apparatus angiography
1 Scope
This standard specifies the angiographic high-pressure injection apparatus (hereinafter referred to as "high-pressure injection apparatus") Terms and Definitions, composition, requirements and test methods.
This standard applies to the high-pressure injection device angiography.
2 Normative references
The following documents for the application of this document is essential. All the reference documents date, only the edition is applicable to this document.
For undated references, the latest edition (including any amendments) applies to this document.
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 Collateral Standard. Safety requirements for medical electrical systems
GB/T 10149-1988 medical X-ray equipment terms and symbols
GB/T 14710-2009 medical electrical environmental requirements and test methods
3 Terms and Definitions
GB/T 10149 defines the following terms and definitions apply to this document.
3.1
Angiography high-pressure injection apparatus angiographicinjector
In the diagnosis or treatment of vascular interventional angiography, in order to obtain the required medical imaging, angiography with X-ray equipment, to a certain time
Between the high-pressure injection device a sufficient amount of a contrast agent bolus to the inspection site.
3.2
Injection head injectorhead
Equipped with push mechanism and supporting component injection syringe.
3.3
Injection rate flowrate
Dosage unit time injection of the contrast agent, unit. milliliter per second (mL/s).
3.4
Rise time risetime
From the injection start time to reach the set injection rate used, unit. seconds.
3.5
The maximum injection pressure maximuminjectionpressure
Injection pressure can reach the maximum pressure injection apparatus.
3.6
Pressure limit pressurelimit
High-pressure injection device is provided to allow the maximum pressure attained during injection.
3.7
Injection delay injectiondelay
A high pressure injection device after receiving the start signal, the delay time after the start of injection is set.
3.8
Exposure Delay X-raydelay
High pressure injection of the injection device after pressing the switch, after the delay time of the trigger signal sent out.
3.9
Drug absorption rate filrate
High pressure injection means per unit time of contrast agent inhaled dose, unit. milliliter per second (mL/s).
4 Composition
The injection device driven by a high voltage and at least a control system, a fixed part and support the attachment and other components.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified, the high-pressure injection device working conditions should be met.
a) Ambient temperature. 10 ℃ ~ 40 ℃;
b) Relative humidity. 30% to 75%;
c) atmospheric pressure. 700hPa ~ 1060hPa.
5.1.2 Power Supply Conditions
Power supply conditions of the high-pressure injection device should be met.
a) a predetermined number of product standard supply voltage and phase network voltage fluctuation should not exceed ± 10% of the nominal value;
b) Power Frequency. 50Hz ± 1Hz products (for export specified by the manufacturer).
5.2 injection rate
Injection pressure injection rate range for heart and great vessels of the apparatus is not to be less than 1.0mL/s ~ 30mL/s, injection rate less than or equal
When at 15mL/s, the deviation should be less than ± 5%, greater than 15mL/s deviation should be less than ± 10%.
Peripheral vascular injection rate for a high pressure range of the injection device is not less than 1.0mL/s ~ 15mL/s, the deviation should be less than ± 5%.
5.3 injected dose
When injected dose range should be not less than 1.0mL ~ 80mL, the injection rate is less than or equal 15mL/s, deviation should not injected dose
When at ± 5%, greater than the injection rate of 15mL/s, the deviation of the injected dose should not exceed ± 10%.
Drug absorption rate 5.4
Product standard drug absorption rate should provide a high pressure injection device, the deviation should be less than ± 5%.
5.5 The maximum injection pressure
Means for high pressure injection of the heart and great vessels can reach a maximum injection pressure not less than 6.89MPa (1000psi).
The maximum injection pressure for high-pressure injection of peripheral devices can achieve not less than 4.13MPa (600psi).
5.6 Pressure limit
When the device shall be provided during the injection pressure limit, pressure limit less 4.13MPa (600psi), the deviation should not exceed
When ± 0.34MPa (50psi), pressure limit is greater than 4.13MPa (600psi), the deviation should be less than ± 0.48MPa (70psi).
5.7 injection delay
Product standards should predetermined injection delay time setting range, the deviation should be less than ± 10%.
5.8 Exposure Delay
Product standards should predetermined exposure delay time setting range, the deviation should be less than ± 10%.
5.9 Rise Time
Product standard predetermined set range should rise time.
5.10 injector head rotation angle
Injection head up and the horizontal angle of not less than 60 °, downwardly and the horizontal angle of not less than 10 °.
5.11 Function
The injection device should have the following features.
a) should have a high-pressure injection device emptying;
b) to show injection rate, injection pressure and injection volume setting value;
c) when the injection pressure exceeds the pressure limit value, a signal should be sent to the user to prompt, and stop injection;
d) high-pressure injection system is to be input and output interfaces, line work and angiographic equipment.
5.12 appearance
Shall meet the following requirements.
a) syringe protective sheath material should enable the user to observe the presence or absence of the bubble contrast agent;
b) cleaning the surface, uniform color, no sharpened edges, burrs and bleeding spots, cracks and other defects;
c) a surface coating, and peeling of the coating should be no scratches;
d) control means fixed firmly, and reliable control.
5.13 environmental testing
Shall comply with the requirements of GB T/14710-2009's. In the initial, intermediate or final test, the equipment are to be used, no abnormal phenomenon.
5.14 Safety
Shall comply with the 9706.1-2007, GB requirements of GB 9706.15-2008.
6 Test methods
6.1 Working conditions
6.1.1 Environmental conditions
Shall comply with the provisions of 5.1.1.
6.1.2 Power Supply Conditions
Power conditions were as follows.
Predetermined a) the number of phases and a net voltage meet the product standards, network voltage fluctuations should not exceed ± 5% of the nominal value;
b) Power Frequency. 50Hz ± 1Hz.
6.2 injection rate
Test medium using distilled or deionized water. Injected dose set 100mL, injection rate are set to the minimum value, maximum value
50% of the maximum under the condition with a timer (e.g., synchronous stopwatch) gauge injection start time to end injection, distilled water for weighing scales, for
The capacity calculation, the injection speed deviation calculated, should meet the requirements of 5.2.
6.3 injected dose
Test medium using distilled or deionized water. Are set to 2 mL of injected dose (injection rate is the minimum), 20mL (injection
50% of the maximum rate), the (maximum injection rate) conditions of 40 mL, distilled weighing scales, in terms of capacity, calculate the injected dose
Deviation should meet the requirements of 5.3.
Drug absorption rate 6.4
Test medium using distilled or deionized water. A timer count signal from the given start to the end of the filling time, by weighing the medicine suction
The weight of the container before and after filling, the filling capacity of the injection is determined, the calculated absorption rate of the drug, should meet the requirements of 5.4.
6.5 The maximum injection pressure
The pressure is limited to a maximum high pressure of the injection device, the syringe connector, a pressure gauge, the injection rate 3mL/s, for pushing
Note, the high pressure reading exceeds the pressure limit indicates the injection device and is stopped when the injection pressure, the maximum injection pressure and to calculate the actual pressure deviation should
To meet the requirements of 5.5.
6.6 Pressure limit
The pressure limits are set to the maximum injection pressure 20% of the value (or a value close), and 80% of the maximum injection pressure value (at or near
Value), the three-way connector is connected with the syringe, pressure gauge, and the catheter, the injection rate of 3mL/s for bolus injection, high-pressure injection reading means for indicating more than
Pressure limiting and pressure during injection is stopped, to calculate the actual pressure deviation and the set pressure, should meet the requirements of 5.5.
6.7 injection delay
Delay time is set to 3s, with the timer count from the received signal to the start of injection, the injection delay deviation is calculated, should be consistent with 5.7
Requirements.
6.8 Exposure Delay
Delay time is set to 3s, counted from the injection start time by a timer to issue a trigger signal, calculates the injection delay deviation should meet
5.8 requirements.
6.9 Rise Time
Practice, shall meet the requirements of 5.9.
6.10 injector head rotation angle
Actual operation, measured with a ruler angle.
6.11 function of the injection device
Practice, shall meet the requirements of 5.11.
6.12 appearance
Actual observation, should meet the requirements of 5.12.
6.13 environmental testing
Conducted in accordance with GB/T 14710-2009's.
6.14 Safety
According to GB 9706.1-2007, GB 9706.15-2008 be prescribed.