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YY/T 1719-2023: (General technical requirements for positron emission tomography and magnetic resonance imaging equipment)
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(General technical requirements for positron emission tomography and magnetic resonance imaging equipment)
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YY/T 1719-2023
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Standard similar to YY/T 1719-2023
Basic data | Standard ID | YY/T 1719-2023 (YY/T1719-2023) | | Description (Translated English) | (General technical requirements for positron emission tomography and magnetic resonance imaging equipment) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 13,195 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2026-01-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms, definitions, requirements and test methods for positron emission tomography and magnetic resonance imaging equipment (including positron emission tomography and magnetic resonance imaging systems, hereinafter referred to as PET/MR). This standard applies to split PET/MR or integrated PET/MR that can be scanned sequentially or synchronously. | YY/T 1719-2023: (General technical requirements for positron emission tomography and magnetic resonance imaging equipment)
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ICS 11.040.55
CCSC43
Pharmaceutical Industry Standard of the People's Republic of China
Positron emission tomography and magnetic resonance imaging equipment
General Technical Requirements
Resonance equipment
2026-01-15 Implementation
Released by the State Drug Administration
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 United Imaging Medical Technology Co., Ltd., Shanghai Medical Device Inspection and Research Institute, Shanghai Medical Devices
Cosmetics Review and Inspection Center.
The main drafters of this document. Pang Hexi, Hu Sheng, Liu Xin, Hu Lingzhi, Shen Zhenhua, Yang Yu, Yang Yiqiang.
Introduction
The properties of the positron emission tomography part (hereinafter referred to as the PET part) in the positron emission tomography and magnetic resonance imaging system
The reference standard for performance and test methods is GB/T 18988.1-2013, performance and test of magnetic resonance imaging part (hereinafter referred to as MR part)
The reference standard of the method is YY/T 1840-2023.
For the PET part, the two methods in the main text of GB/T 18988.1-2013 and Appendix NB have different test requirements and test methods.
There are differences in the phantoms, test conditions, test locations, and calculation methods used, so the two methods of detection items cannot be compared with each other.
For comparison, it is recommended that users of the standard refer to either method in its entirety and should not be cross-used.
Positron emission tomography and magnetic resonance imaging equipment
General Technical Requirements
1 Scope
This document specifies the positron emission tomography and magnetic resonance imaging equipment (including positron emission tomography and magnetic resonance imaging systems)
system, hereinafter referred to as PET/MR) terms and definitions, requirements and test methods.
This document applies to either a split PET/MR or a one-piece PET/MR that can be scanned sequentially or simultaneously.
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 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 17857 Medical Radiology Terminology (Radiation Therapy, Nuclear Medicine and Radiation Dosimetry Equipment)
GB/T 18988.1-2013 Radionuclide Imaging Equipment Performance and Test Rules Part 1.Positron Emission Tomography
device
YY/T 0482 Determination of main image quality parameters of medical magnetic resonance imaging equipment
YY/T 1840-2023 General technical requirements for medical magnetic resonance imaging equipment
YY 9706.233 Medical electrical equipment Part 2-33.Particular requirements for basic safety and essential performance of magnetic resonance equipment for medical diagnosis
3 Terms and Definitions
Defined by GB/T 17857, GB/T 18988.1-2013, YY/T 0482, YY/T 1840-2023 and the following terms and definitions
apply to this document.
3.1
The PET and MR parts sequentially scan and image the same imaging area to achieve image registration.
3.2
The PET and MR parts simultaneously scan and image the same imaging area to achieve image registration.
3.3
Split PET/MR separatedPET/MR
The PET detector center does not coincide with the MR isocenter.
3.4
Integrated PET/MR integratedPET/MR
The PET detector center coincides with the MR isocenter.
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