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YY/T 1745-2021: (Automatic stool analyzer)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1745-2021	English	219	Add to Cart	3 days [Need to translate]	(Automatic stool analyzer)

YY/T 1745-2021: (Automatic stool analyzer)

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(Automatic stool analyzer) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard automatic stool analyzer Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration

foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. Publication of this document Institutions do not assume responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136). This standard was drafted by. Aiwei Technology Co., Ltd., Beijing Medical Device Inspection Institute, Hunan Medical Device Inspection and Testing Institute, Xiamen Store Channel Biotechnology Co., Ltd., Suzhou Hailu Biotechnology Co., Ltd., Xiangyang Keruijie Medical Equipment Co., Ltd. The main drafters of this standard. Zhou Fengliang, Bi Chunlei, Deng Zhenjin, Liao Qinghua, Li Jianglong, Wang Haibo. automatic stool analyzer

1 Scope

This standard specifies the terms and definitions, requirements, test methods, signs, labels and instructions, packaging, transportation and storage of automatic stool analyzers store and so on. This standard applies to the automatic or manual analysis of the physical indicators, tangible components, etc. of human fecal specimens, and provides the tangible components Automatic stool analyzer with live images and other relevant information.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Graphical signs of packaging, storage and transportation GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9.Laboratory use for analysis and other purposes Particular requirements for automatic and semi-automatic equipment GB 4943.1 Information Technology Equipment Safety Part 1.General Requirements GB 9254 Radio Disturbance Limits and Measurement Methods for Information Technology Equipment GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances GB 17625.1 Electromagnetic Compatibility Limits Harmonic Current Emission Limits (Each Phase Input Current of Equipment≤16A) GB/T 18268.1-2010 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements GB/T 18268.26-2010 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26.Special Requirements Looking for in vitro diagnostic (IVD) medical equipment GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 3.In vitro diagnostic instruments for professional use YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements YY 0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101.In Vitro Diagnostic (IVD) Medical Equipment specific requirements

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 It is used for the detection of human fecal samples, which can automatically or manually analyze the physical indicators, formed components, etc. in the feces, and provide the formed components. Instruments for real pictures and other relevant information. 3.2 Fecesphysicalindex Physical indicators in stool samples, including stool color and character. ...