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YY/T 1740.3-2024 English PDF

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YY/T 1740.3-2024: Clinical mass spectrometer - Part 3: Inductively coupled plasma mass spectrometry
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Basic data

Standard ID YY/T 1740.3-2024 (YY/T1740.3-2024)
Description (Translated English) Clinical mass spectrometer - Part 3: Inductively coupled plasma mass spectrometry
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100.10
Word Count Estimation 14,123
Date of Issue 2024-02-07
Date of Implementation 2025-03-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements, labels, instructions for use, packaging, transportation and storage of medical inductively coupled plasma mass spectrometers, and describes the corresponding test methods. This document applies to medical inductively coupled plasma mass spectrometer (ICP-MS), which is mainly used to analyze inorganic elements in human samples, such as potassium, calcium, zinc, iodine, etc.

YY/T 1740.3-2024: Clinical mass spectrometer - Part 3: Inductively coupled plasma mass spectrometry


---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.
ICS 11.100.10 CCSC44 Pharmaceutical Industry Standards of the People's Republic of China Medical mass spectrometers Part 3. Inductively Coupled Plasma Mass Spectrometer Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting is required. This document is part 3 of YY/T 1740 “Medical Mass Spectrometers”. YY/T 1740 has been published in the following parts. --- Part 1.Liquid chromatography-mass spectrometry; --- Part 2.Matrix-assisted laser desorption ionization time-of-flight mass spectrometry; --- Part 3.Inductively coupled plasma mass spectrometer. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Beijing Medical Device Inspection Institute (Beijing Medical Bioprotection Equipment Inspection and Research Center), Capital Medical University Beijing Tongren Hospital affiliated to the University of Science and Technology, Zhejiang Medical Device Evaluation Center, First Medical Center of the General Hospital of the Chinese People's Liberation Army, Shandong Yingshengsheng Biotechnology Co., Ltd., Ruilaipu (Hangzhou) Medical Technology Co., Ltd., Tianjin Guoke Medical Technology Development Co., Ltd., Beijing Yixinbo Chuangsheng Technology Co., Ltd. and Mekang Biotechnology Co., Ltd. The main drafters of this document are. Li Shengmin, Liu Xiangyi, Ye Chaofu, Duan Jinyan, Cui Wenbin, Zheng Yi, Cheng Wenbo, Ma Qingwei, Shen Min, and Zhao Bingfeng.

Introduction

YY/T 1740 "Medical Mass Spectrometer" is divided into 4 parts. --- Part 1.Liquid chromatography-mass spectrometry. The purpose is to specify the requirements, test methods, Labelling, instructions for use, packaging, transportation and storage. --- Part 2.Matrix-assisted laser desorption ionization time-of-flight mass spectrometer. The purpose is to specify the medical matrix-assisted laser desorption ionization time-of-flight mass spectrometer Performance requirements, test methods, identification, labeling and instructions, packaging, transportation and storage of time-of-flight mass spectrometers. --- Part 3.Inductively coupled plasma mass spectrometer. The purpose is to specify the performance requirements of medical inductively coupled plasma mass spectrometers, Test methods, labeling, instructions for use, packaging, transportation and storage. --- Part 4.Gas chromatograph-mass spectrometer. The purpose is to specify the performance requirements and test methods of medical gas chromatograph-mass spectrometer. Method, labeling, instructions for use, packaging, transportation and storage. Medical mass spectrometers Part 3. Inductively Coupled Plasma Mass Spectrometer

1 Scope

This document specifies the requirements, labeling, instructions for use, packaging, transportation and storage of medical inductively coupled plasma mass spectrometers. Appropriate test method. This document applies to medical inductively coupled plasma mass spectrometer (ICP-MS), which is mainly used to analyze inorganic elements in human samples. Elements such as potassium, calcium, zinc, iodine, etc.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 191 Pictorial markings for 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.Electrical equipment for laboratory analysis and other purposes Special requirements for automatic 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 for in vitro Diagnostic (IVD) Medical Devices GB/T 29791.3 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic instruments YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101.In vitro diagnostic (IVD) medical equipment Special requirements for

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Mass range massrange A range between the lower and upper limits of the mass-to-charge ratio that a mass spectrometer can measure. [Source. GB/T 6041-2020, 2.4, modified] Note. The unit is expressed in u. 3.2 Mass resolution Mass resolution is expressed as the peak width at 10% of the mass peak height of an element. [Source. JJF1159-2006, 3.2, modified] Note. The unit is expressed in u.

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