HOME   Cart(0)   Quotation   About-Us Tax PDFs Standard-List Powered by Google www.ChineseStandard.net Database: 189760 (15 Feb 2025)

YY/T 1928-2023 English PDF

YY/T 1928-2023_English: PDF (YY/T1928-2023)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1928-2023English599 Add to Cart 5 days [Need to translate] Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment Valid YY/T 1928-2023


BASIC DATA
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] ......

Similar standards: YY/T 1930-2024  YY/T 1535-2024  
Similar PDFs (Auto-delivered in 9 seconds): YY/T 1943-2024  YY/T 1897-2023  YY/T 1879-2022  YY/T 1843-2022