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YY/T 1903-2024 English PDF

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YY/T 1903-2024: Characteristics and test conditions for cardiac single photon emission computed tomography device
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Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1903-2024	English	539	Add to Cart	5 days [Need to translate]	Characteristics and test conditions for cardiac single photon emission computed tomography device	Valid	YY/T 1903-2024

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Basic data

Standard ID	YY/T 1903-2024 (YY/T1903-2024)
Description (Translated English)	Characteristics and test conditions for cardiac single photon emission computed tomography device
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C43
Classification of International Standard	11.040.50
Word Count Estimation	26,217
Date of Issue	2024-02-07
Date of Implementation	2025-03-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the performance of single-photon emission computed tomography (SPECT) systems dedicated to cardiac tomography and describes the corresponding test methods. These systems include SPECT systems dedicated only to cardiac tomography, or general-purpose SPECT systems with a dedicated cardiac tomography subsystem that is outside the scope of the gamma camera standard for planar, whole-body, and SPECT imaging.

YY/T 1903-2024: Characteristics and test conditions for cardiac single photon emission computed tomography device

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ICS 11.040.50 CCSC43 Pharmaceutical Industry Standards of the People's Republic of China Cardiac single photon emission computed tomography device Performance and test rules testconditions-Part 1.CardiacSPECT,MOD) Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Performance and test methods 2 4.1 Overview 2 4.2 Probe Performance 3 4.3 Performance of tomographic images 9 5 Other tests19 6 Attached Documents 19 References 20

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. This document is modified to adopt IEC 63073-1.2020 "Specialized radionuclide imaging equipment performance and test rules Part 1.Heart SPECT. This document has made the following structural adjustments compared to IEC 63073-1.2020. --- Removed term index. The following editorial changes were made to this document. --- In order to coordinate with the existing standards, the name of the standard is changed to "Performance and test of cardiac single photon emission computed tomography equipment" rule"; ---Changed ±10% and ±20% in the whole text to corresponding values; --- Added the English equivalents of CCFOV and CUFOV (see 3.5 and 3.6). 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 sponsored by the National Technical Committee for Standardization of Medical Electrical Appliances, Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment Technical Committee (SAC/TC10/SC3) This document was drafted by. Beijing Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), Hamamatsu Photonics Technology (Langfang) Co., Ltd., GE Medical Systems Trading Development (Shanghai) Co., Ltd., Shanghai Guangmai Medical Technology Co., Ltd., China The First Medical Center of the People's Liberation Army General Hospital and Cancer Hospital of the Chinese Academy of Medical Sciences. The main drafters of this document are. Liu Di, Peng Linan, Meng Fanbo, Mao Junfeng, Chen Yingmao, Geng Jianhua and Xu Yue. Cardiac single photon emission computed tomography device Performance and test rules

1 Scope

This document specifies the performance of single photon emission computed tomography (SPECT) systems for cardiac tomographic imaging. These systems include SPECT systems dedicated only to cardiac tomography, or systems with dedicated cardiac tomography. Generic SPECT system with subsystems that are not within the scope of the Gamma Camera Standard 1 for planar, whole body and SPECT imaging. 1) See IEC 61675-2.2015.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. IEC 61675-2.2015 Performance and test rules for radionuclide imaging equipment Part 2.Rules for use with planar, whole-body and Note. GB/T 18988.2-2013 Performance and test rules for radionuclide imaging equipment Part 2.Single photon emission computed tomography equipment (IEC 61675-2.1998,MOD)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 reference point A three-dimensional position specified in the field of view (FOV) of a gamma camera, as specified by the manufacturer; if the manufacturer does not specify If, then it is determined as the center of the gamma camera FOV. 3.2 bad pixel badpixel Gamma cameras that are unable to collect data due to physical or electronic shutdown, making it impossible to record the gamma-ray interactions that occur within them The pixels of the probe. 3.3 cardiac detector head The collection of all probe components associated with a single collimator. 3.4 The smallest discrete unit in a cardiac probe that can provide information about the energy, space, and time of the detected photons.

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