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YY/T 1784-2021: Blood gas analyzer
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1784-2021 | English | 199 |
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Blood gas analyzer
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YY/T 1784-2021
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PDF similar to YY/T 1784-2021
Basic data | Standard ID | YY/T 1784-2021 (YY/T1784-2021) | | Description (Translated English) | Blood gas analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 10,115 | | Issuing agency(ies) | State Drug Administration | 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:
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