YY/T 1708.3-2021Basic requirements of communication and conformance for medical X-ray image equipment - Part 3: Digital radiography system (English PDF)
医用诊断X射线影像设备连通性符合性基本要求 第3部分：数字化摄影X射线机
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 1708.3-2021 is the English-translated version of 医用诊断X射线影像设备连通性符合性基本要求 第3部分：数字化摄影X射线机.
YY/T 1708.3-2021 is the Chinese pharmaceutical industry standard that sets the connectivity requirements for the digital radiography X-ray machine and its software components, building on part 1 of the YY/T 1708 series.
It gives the terms and definitions, the requirements and the test methods by which conformance is shown: the information the machine must be able to exchange, the services and formats it must support when health data are written to digital media or sent over a network, and the conformance statement the manufacturer must publish.
It applies to digital radiography equipment that stores or transmits health data and to the software that goes with it. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 1708.3-2021
National Standard of the People's Republic of China
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 requirements
- 4.1 Compatibility
- 4.2 Reliability
- 4.3 Cybersecurity
- 4.4 Maintainability
- 4.5 Portability
- 5 Test method
- 5.1 Compatibility
- 5.2 Reliability
- 5.3 Cybersecurity
- 5.4 Maintainability
- 5.5 Portability
- Appendix A (Informative Appendix) DR Declaration of Conformity Template
Foreword
YY/T 1708 "Basic Requirements for Connectivity Compliance of Medical Diagnostic X-ray Imaging Equipment" is divided into the following 6 parts.
--- Part 1: General requirements;
--- Part 2: X-ray computed tomography equipment;
--- Part 3: Digital photographic X-ray machines;
--- Part 4: Digital subtraction angiography X-ray machine;
--- Part 5: Mammography machine;
--- Part 6: Oral X-ray machine. This part is Part 3 of YY/T 1708.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This part of YY/T 1708 specifies the digital photographic X-ray machine (DR) and its related software on the basis of Part 1 Terms and definitions, requirements and test methods for connectivity compliance of components.
This section applies to digital photographic X-ray machines that can store health data through digital media or transmit health data through a network and its related software components.
This section does not apply to digital photographic X-ray machines that do not have the function of storing digital media and transmitting health data through the network (DR) and its associated software components.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 2312-1980 Basic set of Chinese coded character set for information exchange
GB/T 10149 Terms and Symbols of Medical X-ray Equipment
GB 18030 Information Technology Chinese Coded Character Set
YY/T 1708.1-2020 Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment Part 1: General requirements CharacterSet(UCS)] GB K Chinese Character Internal Code Extension Specification
3 Terms and Definitions GB/T 10149 and the following
terms and definitions apply to this document.
3.1 Application entity applicationentity; AE
An activity element within an application process that contains a set of capabilities related to the Open Systems Interconnection (OSI) and defined for the application layer, corresponding to a specific set of capabilities. The specified application entity type (excluding redundant capabilities in use). [GB/T 9387.1-1998, definition 7.1.1.1]
3.2 Application framework
The media storage application framework defines options at different levels of the DICOM media storage model for which DICOM media storage applies The need and context for a media swap operation to be performed for a specific intended purpose. [DICOMPS3.10, Definition 3.8]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 2312-1980Code of Chinese graphic character setfor information interchange--Primary set
- GB/T 10149Terminology and symbol for medical X-ray equipment
- GB 18030Information technology - Chinese coded character set
- YY/T 1708.1-2020Basic requirements of communication and conformance for medical diagnostic X-ray image equipment - Part 1: General requirements
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Related Standards
GB 18030-2022 — Information technology - Chinese coded character set
GB/T 10149-1988 — Terminology and symbol for medical X-ray equipment
GB/T 2312-1980 — Code of Chinese graphic character setfor information interchange--Primary set
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