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www.ChineseStandard.net Database: 189760 (25 Oct 2025)

YY/T 1861-2023 English PDF

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YY/T 1861-2023: (Special technical requirements for medical image storage and transmission system software)
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1861-2023	English	469	Add to Cart	4 days [Need to translate]	(Special technical requirements for medical image storage and transmission system software)	Valid	YY/T 1861-2023

Standard similar to YY/T 1861-2023

Basic data

Standard ID	YY/T 1861-2023 (YY/T1861-2023)
Description (Translated English)	(Special technical requirements for medical image storage and transmission system software)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of International Standard	11.040.50
Word Count Estimation	22,230
Date of Issue	2023-01-13
Date of Implementation	2024-01-15
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements and test methods for medical image storage and transmission system software. This standard applies to medical image storage and transmission system software. This standard does not apply to image storage and transmission systems that do not use the DICOM protocol.

YY/T 1861-2023: (Special technical requirements for medical image storage and transmission system software)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.50 CCSC43 Pharmaceutical Industry Standard of the People's Republic of China Medical image storage and transmission system software special technical conditions Released 2023-01-13 2024-01-15 Implementation Released by the State Drug Administration

Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements and inspection methods 3 4.1 General requirements 3 4.2 Functionality and usability4 4.3 Performance efficiency 8 4.4 Reliability10 4.5 Network Security 11 4.6 Maintainability 15 4.7 Compatibility 15 4.8 Portability 16 Appendix A (Informative) Uncertainty Evaluation of Measurement Functions 17 Reference 18

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 Medical X-ray Equipment and Appliances Sub-Technical Committee of the National Standardization Technical Committee of Medical Electrical Appliances (SAC/TC10/SC1) Focus on. This document was drafted by. Liaoning Medical Device Inspection and Testing Institute, Medical Device Technology Evaluation Center of the State Drug Administration, China Peking Union Medical College Hospital of Academy of Medical Sciences, Liaoning Inspection and Testing Certification Center, Zhejiang Medical Device Evaluation Center, China Food and Drug Testing Institute Institute, Shanghai Institute of Medical Device Testing, General Electric Medical Systems Trade Development (Shanghai) Co., Ltd., Siemens Medical Systems Co., Ltd. Company, Canon Medical Systems (China) Co., Ltd., Wuhan United Imaging Medical Technology Co., Ltd., Agfa Medical System Equipment (Shanghai) Co., Ltd. Division, Fujifilm (China) Investment Co., Ltd. The main drafters of this document. Zhang Longda, Sun Zhiyong, Li Fei, Bao Yaqing, Sun Hao, Chen Fujun, Zhu Wenwu, Li Shu, Liu Chongsheng, Qin Chuan, Li Yajing, Li Wei, Mingxing, Zhang Jinping, Tang Zhiwei. Medical image storage and transmission system software special technical conditions

1 Scope

This document specifies the requirements and inspection methods for medical image storage and transmission system software. This document applies to medical image storage and transmission system software. This document does not apply to image storage and transmission systems that do not use the DICOM protocol.

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 18030 Information Technology Chinese Coded Character Set GB/T 25000.10 System and software engineering System and software quality requirements and evaluation (SQuaRE) Part 10.System and software Software Quality Model

3 Terms and Definitions

The following terms and definitions defined in GB/T 25000.10 apply to this document. 3.1 Provides storage, transmission, and software for display and processing functions after medical images are acquired. 3.2 Based on the public cloud or private cloud, the storage and transmission of medical images for diagnosis can also include services such as display and processing. 3.3 Accompanying document accompanying document The contents of the documentation accompanying the software contain information for the responsible party or operator. 3.4 operator operator The person who operates the software. [Source. GB 9706.1-2020, 3.73, modified] 3.5 user An organization or individual who uses software and obtains benefits. Note. The user role and operator role may be given to the same individual or organization at the same time or successively. [Source. GB/T 25000.51-2016, 4.1.25, modified]

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