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YY/T 1861-2023Particular specification of picture archiving and communication system software (English PDF)

医学影像存储与传输系统软件专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 13, 2023

Implementation date

January 15, 2024

Scope

YY/T 1861-2023 is the English-translated version of 医学影像存储与传输系统软件专用技术条件.

YY/T 1861-2023 is the Chinese standard "Particular specification of picture archiving and communication system software". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY/T 1861-2023

National Standard of the People's Republic of China

ICS: 11.040.50

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirements and inspection methods
4.1 General requirements
4.2 Functionality and usability
4.3 Performance efficiency
4.4 Reliability
4.5 Network Security
4.6 Maintainability
4.7 Compatibility
4.8 Portability
Appendix A (Informative) Uncertainty Evaluation of Measurement Functions

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

The contents of the documentation accompanying the software contain information for the responsible party or operator.

3.4 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

HJ 1198|GJB 1763

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