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YY/T 0891-2013 related PDF English

YY/T 0891-2013 (YY/T0891-2013, YYT 0891-2013, YYT0891-2013) & related versions
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YY/T 0891-2013: PDF in English (YYT 0891-2013)
YY/T 0891-2013 YY 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 ......

BASIC DATA
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