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Clinical mass spectrometer - Part 1: Liquid chromatography-mass spectrometer
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Basic data
| Standard ID | YY/T 1740.1-2021 (YY/T1740.1-2021) |
| Description (Translated English) | Clinical mass spectrometer - Part 1: Liquid chromatography-mass spectrometer |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Word Count Estimation | 13,152 |
| Issuing agency(ies) | State Drug Administration |
YY/T 1740.1-2021: Clinical mass spectrometer - Part 1: Liquid chromatography-mass spectrometer
---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.
Clinical mass spectrometer - Part 1.Liquid chromatography-mass spectrometer
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standards
Medical mass spectrometer
Part 1.Liquid Chromatography-Mass Spectrometer
Released on 2021-03-09
2022-10-01 implementation
Issued by the National Medical Products 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 spectrometer.
This part is part 1 of YY/T 1740.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this section. Beijing Institute of Medical Device Inspection, Beijing Tongren Hospital Affiliated to Capital Medical University, Clinical Laboratory Center of the Ministry of Health,
Peking Union Medical College Hospital, Guangzhou Jinyu Medical Laboratory Group Co., Ltd., Mecang Biotechnology Co., Ltd.
The main drafters of this section. Peng Xu, Li Shengmin, Liu Xiangyi, Zhang Tianjiao, Cheng Xinqi, Zhao Beibei, Shen Min, Zou Yingshu.
Medical mass spectrometer
Part 1.Liquid Chromatography-Mass Spectrometer
1 Scope
This part of YY/T 1740 specifies the requirements, test methods, labels, instructions for use, packaging,
Transportation and storage.
This part is applicable to single quadrupole and triple quadrupole liquid chromatography-mass spectrometer (hereinafter referred to as liquid chromatography-mass spectrometer), which mainly
It is used to analyze molecular substances in human samples such as blood and urine, such as proteins, small metabolic molecules, drugs, etc.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 191 Packaging, storage and transportation pictorial signs
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use Part 6.Characteristics of material heating equipment for laboratory use
Special requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 9.Laboratory use for analysis and other purposes
Special requirements for mobile and semi-automatic equipment
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
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
External diagnostic (IVD) medical equipment
GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3.In vitro diagnostic devices 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
Dedicated requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Massaccuracy
The deviation between the mass spectrometer's measured value of ion mass and the theoretical value.
[GB/T 32267-2015, definition 4.5]
3.2
Masschargeratio,m/z
The ratio of the mass of an ion (m) to the number of charges it carries (z).
[GB/T 32267-2015, definition 4.6]
...
