YY/T 0891-2013 English PDF (YYT0891-2013)
YY/T 0891-2013 English PDF (YYT0891-2013)
YY/T 0891-2013: Particular specifications for angiographic injector
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
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
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.
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.
The part equipped with injection push mechanism and supporting syringe. 3.3
The dosage of the contrast agent injected per unit of time, in milliliters per second (mL/s).
The time taken from the start of the injection to when it reaches the set flow rate, in seconds.
maximum injection pressure
The maximum pressure that can be reached at the time of injection of an injector. 3.6
The maximum allowable pressure during injection of an injector.
After receiving the start signal, the injector starts the injection after a set delay time. 3.8
After pressing the injection switch, the injector sends out the trigger signal after a set delay time.
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