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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1840-2023 English PDF

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YY/T 1840-2023: (General technical requirements for medical magnetic resonance imaging equipment)
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1840-2023	English	589	Add to Cart	5 days [Need to translate]	(General technical requirements for medical magnetic resonance imaging equipment)	Valid	YY/T 1840-2023

Standard similar to YY/T 1840-2023

Basic data

Standard ID	YY/T 1840-2023 (YY/T1840-2023)
Description (Translated English)	(General technical requirements for medical magnetic resonance imaging equipment)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of International Standard	11.040.50
Word Count Estimation	28,210
Date of Issue	2023-01-13
Date of Implementation	2026-01-15
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements and test methods for medical magnetic resonance imaging equipment. This standard applies to superconducting magnetic resonance imaging equipment, permanent magnetic magnetic resonance imaging equipment and constant conduction magnetic resonance imaging equipment.

YY/T 1840-2023: (General technical requirements for medical magnetic resonance imaging equipment)

---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 11.040.50 CCSC39 Pharmaceutical Industry Standard of the People's Republic of China General technical requirements for medical magnetic resonance imaging equipment Released on 2023-01-13 2026-01-15 Implementation Released by the State Drug Administration

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 7 Appendix A (Normative) Normative Form 13 Appendix B (informative) Notes and Recommendations 19

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. Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is sponsored by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) Focus on. This document is drafted by. Shanghai Institute of Medical Device Inspection, Medical Device Technology Evaluation Center of the State Drug Administration. The main drafters of this document. Hu Sheng, Yang Pengfei, Yang Yu, Liu Jiong. General technical requirements for medical magnetic resonance imaging equipment

1 Scope

This document specifies the requirements and test methods for medical magnetic resonance imaging equipment. This document is applicable to superconducting magnetic resonance imaging equipment, permanent magnetic magnetic resonance imaging equipment and conventional magnetic resonance imaging equipment.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document. GB 7247.1 Safety of Laser Products Part 1.Equipment Classification and Requirements GB 9706.1-2020 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance GB 9706.227-2021 Medical Electrical Equipment Part 2-27.Special for the basic safety and basic performance of ECG monitoring equipment Require GB/T 14710 Environmental requirements and test methods for medical electrical appliances YY/T 0482-2022 Determination of main image quality parameters of medical imaging magnetic resonance equipment YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Collateral Standard. Electromagnetic Compatibility Content requirements and tests YY 9706.233-2021 Medical electrical equipment Part 2-33.Basic safety and fundamentals of magnetic resonance equipment for medical diagnosis special request YY 9706.261-2023 Medical Electrical Equipment Part 2-61.Special for the Basic Safety and Essential Performance of Pulse Oximeter Equipment Require

3 Terms and Definitions

The following terms and definitions defined in YY/T 0482-2022 apply to this document. 3.1 Composed of some sub-coil units, it is used to detect signals in a certain limited area, and is given by the combination of signal receiving links of each sub-coil. The resulting digital signal covers the entire coil area of the medium. 3.2 The main magnet used to generate the static magnetic field is a superconducting magnet in MRI equipment. 3.3 The main magnet used to generate the static magnetic field is an MRI device made of permanent magnetic material. 3.4 The main magnet used to generate the static magnetic field is a magnetic resonance imaging device with a constant conduction magnet.

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