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YY/T 1784-2021: Blood gas analyzer
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1784-2021	English	199	Add to Cart	3 days [Need to translate]	Blood gas analyzer

YY/T 1784-2021: Blood gas analyzer

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Blood gas analyzer ICS 11:100:10 C44 People's Republic of China Pharmaceutical Industry Standard blood gas analyzer Published on 2021-12-06 2023-05-01 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: Beijing Medical Device Inspection Institute, Jiangsu Institute of Metrology, Xuanwu Hospital of Capital Medical University, Shenzhen Kangli Biomedical Co:, Ltd:, Beijing Representative Office of Nova Biomedical Co:, Ltd:, Radiometer Medical Equipment (Shanghai) Co:, Ltd:, Wofen Medical Device Trading (Beijing) Co:, Ltd:, Siemens Medical Diagnostics (Shanghai) Co:, Ltd: The main drafters of this standard: Zhao Bingfeng, Cui Hongen, Liu Chengeng, Huang Biao, Wang Wenwen, Ge Yawen, Luo Chunli, Dai Jinxing: blood gas analyzer

1 Scope

This standard specifies the basic parameters, requirements, test methods, signs, labels, instructions for use and packaging, transportation and storage of blood gas analyzers: This standard applies to the use of selective electrodes as sensors, through electrochemical technology, blood samples of human blood or other body fluid samples: A blood gas analyzer for the detection of pH, partial pressure of carbon dioxide (pCO2), and partial pressure of oxygen (pO2):

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 Analysis and Other Purposes Automatic and special requirements for semi-automatic equipment GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Equipment GB/T 18268:1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements GB/T 18268:26 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26: Special Requirements In vitro diagnostic (IVD) medical devices 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 0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101: In Vitro Diagnostic (IVD) Medical Equipment specific requirements

3 Requirements

3:1 Performance Requirements 3:1:1 Accuracy The accuracy of the instrument should meet the accuracy requirements in Table 1: 3:1:2 Precision The precision of the instrument should meet the precision requirements in Table 1: 3:1:3 Linear The linearity of the instrument should meet the linearity requirements in Table 1: 3:1:4 Stability Instrument stability should meet the stability requirements in Table 1: ...