YY/T 1928-2023_English: PDF (YY/T1928-2023)
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Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment
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YY/T 1928-2023
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Standard ID | YY/T 1928-2023 (YY/T1928-2023) | Description (Translated English) | Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C30 | Classification of International Standard | 11.040.01 | Word Count Estimation | 30,369 | Date of Issue | 2023-11-22 | Date of Implementation | 2024-12-01 | Drafting Organization | Medical Device Technology Review Center of the State Drug Administration, Shanghai Institute of Medical Device Inspection, Fudan University, Beijing Medical Device Review and Inspection Center, Shenzhen Mindray Biomedical Electronics Co., Ltd., Lanzhou University | Administrative Organization | National Medical Electrical Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC 10/SC 5) | Proposing organization | State Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the terminology of medical electrical equipment intended to be used in the magnetic resonance environment and the classification of medical electrical equipment intended to be used in the magnetic resonance environment. This standard applies to medical electrical equipment used in magnetic resonance environments. |
YY/T 1928-2023.Terminology and classification of medical electrical equipment intended for use in a magnetic resonance environment
ICS 11.040.01
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Medical electrical equipment intended for use in a magnetic resonance environment
Terminology and classification
Released on 2023-11-22
2024-12-01 implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 Category 12
Appendix A (Normative) Safety marking requirements for magnetic resonance environments 14
Appendix B (Informative) Examples of marking of medical devices that are safe for magnetic resonance conditions 18
Appendix C (Informative) Additional Notes on Magnetic Resonance Environment Safety 21
Reference 25
Preface
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 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 provided by the National Technical Committee for Standardization of Medical Electrical Appliances, Medical Electronic Instruments Standardization Subcommittee (SAC/TC10/SC5)
Centralized.
This document was drafted by. National Medical Products Administration Medical Device Technical Evaluation Center, Shanghai Medical Device Inspection Institute, Fudan University
University, Beijing Medical Device Evaluation and Inspection Center, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and Lanzhou University.
The main drafters of this document are. Wang Jing, Hong Wei, Yang Pengfei, Wu Xiaomei, Chen Ran, Li Yonghua, Tao Hua, and Yao Aiping.
Medical electrical equipment intended for use in a magnetic resonance environment
Terminology and classification
1 Scope
This document defines the terminology for medical electrical equipment intended for use in a magnetic resonance environment and specifies the
Classification of gas equipment.
This document applies to medical electrical equipment used in a magnetic resonance environment.
2 Normative references
This document has no normative references.
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Magnetic resonance; MR
The phenomenon of resonance absorption of electromagnetic field energy of a specific frequency by a group of atomic nuclei placed in a magnetic field.
NOTE. In this document, the magnetic field generally refers to the composite field of the static magnetic field and the gradient field of the magnetic resonance equipment used for medical diagnosis.
[Source. YY 9706.233-2021,.201.3.217, modified]
3.2
MRequipment
Medical electrical equipment intended for magnetic resonance imaging of humans (3.5), including all hardware and software from the mains power supply to the display monitor
part.
[Source. YY 9706.233-2021,.201.3.218, modified]
3.3
MR system
The combination of magnetic resonance equipment (3.2), accessories (including display, control and energy supply devices) and controlled access area (if any).
[Source. YY 9706.233-2021,.201.3.220]
3.4
MRenvironment
The three-dimensional volume of space around the magnetic resonance device (3.2), which includes the volume of space inside the Faraday shield and the volume of space inside the 0.5 mT
The spatial volume within the contour of the magnetic field contour (5 Gauss line). This three-dimensional spatial volume refers to the exposure of the medical device to the magnetic resonance equipment and its accessories
Areas where electromagnetic fields may cause danger.
[Source. ASTM F2503-20, 3.1.10, modified]
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