YY/T 1840-2023General specifications for medical magnetic resonance equipment (English PDF)
医用磁共振成像设备通用技术条件
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 13, 2023
Implementation date
January 15, 2026
Scope
YY/T 1840-2023 is the English-translated version of 医用磁共振成像设备通用技术条件.
YY/T 1840-2023 is the Chinese standard "General specifications for medical magnetic resonance equipment". Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — YY/T 1840-2023
National Standard of the People's Republic of China
- ICS
- 11.040.50
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 5 Test method
- Appendix A (Normative) Normative Form
- Appendix B (informative) Notes and Recommendations
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 7247.1Safety of laser products - Part 1: Equipment classification and requirements
- GB 9706.1-2020Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.227-2021Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY/T 0482-2022Magnetic resonance equipment for medical imaging—Determination of essential image quality parameters
- YY 9706.102Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Similar standards
HJ 1198|GJB 1763
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Related Standards
GB 7247.1-2012 — 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: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
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YY/T 1840-2023
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