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YY/T 1740.2-2021: (Part 2: Auxiliary Laser Absorption Ionization Time-of-Flight Instrument)
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YY/T 1740.2-2021
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Basic data | Standard ID | YY/T 1740.2-2021 (YY/T1740.2-2021) | | Description (Translated English) | (Part 2: Auxiliary Laser Absorption Ionization Time-of-Flight Instrument) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 15,147 | | Issuing agency(ies) | State Drug Administration | YY/T 1740.2-2021: (Part 2: Auxiliary Laser Absorption Ionization Time-of-Flight Instrument)---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.
(Part 2.Auxiliary Laser Absorption Ionization Time-of-Flight Instrument)
ICS 11.100.10
C44
People's Republic of China Pharmaceutical Industry Standard
Medical Mass Spectrometers Part 2.Matrix Assisted Lasers
Desorption ionization time-of-flight mass spectrometer
Published on 2021-09-06
2023-03-01 Implementation
Released by the State Drug Administration
foreword
YY/T 1740 "Medical Mass Spectrometer" is divided into 4 parts.
--- Part 1.Liquid chromatography-mass spectrometry;
--- Part 2.Matrix-assisted laser desorption ionization time-of-flight mass spectrometer;
--- Part 3.Gas chromatography-mass spectrometry;
--- Part 4.Inorganic mass spectrometers.
This part is Part 2 of YY/T 1740.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136).
This section is drafted by. Beijing Medical Device Inspection Institute, Antu Experimental Instruments (Zhengzhou) Co., Ltd., General Hospital of the Chinese People's Liberation Army,
Beijing Yixin Bochuang Company Biotechnology Co., Ltd., Bruker (Beijing) Technology Co., Ltd., China National Institute for Food and Drug Control, Kinerson
Technology (Shanghai) Co., Ltd., Jiangsu Tianrui Instrument Co., Ltd. Fujian Branch, and Zhuhai Meihua Medical Technology Co., Ltd.
The main drafters of this section. Zou Yingshu, Cai Keya, Wang Chengbin, Ma Qingwei, Zhou Chunxi, Liu Donglai, Stefan Berkenkamp, Lin Zhimin,
Feng Liping.
Medical Mass Spectrometers Part 2.Matrix Assisted Lasers
Desorption ionization time-of-flight mass spectrometer
1 Scope
This part of YY/T 1740 specifies the requirements, test methods, identification,
Labels and instructions, packaging, transportation and storage.
This section applies to medical mass spectrometry using matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOFMS for short).
It is mainly used for the identification of microbial protein fingerprints of clinical samples, nucleic acid detection of biological samples, etc.
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 7247.1 Safety of Laser Products Part 1.Equipment Classification and Requirements
GB/T 14710 Medical Electrical Environment Requirements and Test Methods
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 Terms and Definitions, Abbreviations
3.1 Terms and Definitions
The following terms and definitions apply to this document.
3.1.1
massrange
The range between the lower mass-to-charge ratio and the upper mass-to-charge ratio that can be measured by a mass spectrometer.
[GB/T 32267-2015, definition 4.7]
3.1.2
mass accuracy massaccuracy
The deviation of the mass-to-charge ratio measured by the mass spectrometer from the theoretical value.
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