YY/T 1708.4-2021Basic requirements of communication and conformance for medical X-ray image equipment - Part 4: Digital subtraction angiography equipment (English PDF)
医用诊断X射线影像设备连通性符合性基本要求 第4部分：数字减影血管造影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 1708.4-2021 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4部分：数字减影血管造影X射线机.
YY/T 1708.4-2021 is the Chinese pharmaceutical industry standard that sets the connectivity requirements for digital subtraction angiography equipment 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 for conformance: what the machine must be able to store on digital media or send over a network, the services and formats it must support, and the conformance statement the manufacturer must publish.
It applies to angiographic X-ray equipment with a digital subtraction function and to its associated components. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 1708.4-2021
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) Digital Subtraction Angiography (DSA) DICOM 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 4 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 subtraction angiography X-ray machine (referred to as DSA) and its phase on the basis of Part 1.
Definition of terms, requirements and test methods for connectivity compliance of related software components.
This part applies to medical blood vessels with digital subtraction function that can store health data through digital media or transmit through the network Contrast X-ray machine equipment and its associated components.
This section does not apply to medical blood vessels that do not have the function of digital media storage and network transmission of health data or do not have the function of digital subtraction Contrast X-ray machine equipment and its associated 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 Medical angiography X-ray machine with digital subtraction function
Note. In the DICOM standard specification, it is customary to use "XA" to indicate.
3.2 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]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 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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