YY/T 1708.2-2020Basic requirements of communication and conformance for medical X-ray image equipment - Part 2: X-ray equipment for computed tomography (English PDF)
医用诊断X射线影像设备连通性符合性基本要求 第2部分：X射线计算机体层摄影设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 27, 2020
Implementation date
September 1, 2021
Scope
YY/T 1708.2-2020 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2部分：X射线计算机体层摄影设备.
YY/T 1708.2-2020 is the Chinese pharmaceutical industry standard that sets the connectivity requirements for X-ray computed tomography 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: the data a CT scanner must be able to store or transmit, among them the images and the dose report, the services and formats it must support, and the conformance statement that accompanies it. Issued on 27 September 2020, it has applied since 1 September 2021.
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Document preview — YY/T 1708.2-2020
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Requirements
- 4.1 Compatibility
- 4.1.1 DICOM compliance
- 4.1.2 Security software
- 4.2 Reliability
- 4.3 Cyber Security
- 4.3.1 Confidentiality
- 4.3.2 Integrity
- 4.3.3 Availability
- 4.3.4 Audit
- 4.3.5 Other additional requirements
- 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) CT conformity declaration template
Foreword
YY/T 1708 "Basic Requirements for Connectivity and Compliance of Medical Diagnostic X-ray Imaging Equipment" is divided into the following parts.
---Part 1. General requirements;
---Part 2. X-ray computed tomography equipment;
---Part 3. Digital X-ray machine (DR);
---Part 4. Digital Subtraction Angiography X-ray Machine (DSA);
---Part 5. Mammary X-ray machine;
---Part 6. Oral X-ray machine. This part is Part 2 of YY/T 1708.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
1 Scope
This part of YY/T 1708 specifies the X-ray computed tomography equipment (CT) and its phase based on YY/T 1708.1 Terms and definitions, requirements and test methods for the connectivity compliance of related software components.
This part is applicable to X-ray computed tomography with the function of storing health data through digital media or transmitting health data through the network Equipment and related software components, this section does not apply to X that does not have the function of digital media storage and the function of transmitting health data through the network. Radiographic computed tomography equipment (CT) and related software components.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.
GB/T 2312-1980 Chinese character coded character set basic set for information exchange
GB/T 10149 Medical X-ray equipment terms and symbols
GB 18030 Information Technology Chinese Coded Character Set
YY/T 1708.1-2020 Basic requirements for connectivity of medical diagnostic X-ray imaging equipment Part 1. General requirements ISO /IEC 10646 Information Technology Universal Coded Character Set (UCS) [Informationtechnology-UniversalCoded CharacterSet(UCS)] DICOM3.0 Digital Imaging and Communication in Medicine (DigitalImagingandCommunicationsinMedicinePS3) GB K Chinese character inner code extension specification
3 Terms and definitions
The following terms and definitions defined in GB/T 10149 apply to this document.
3.1 Application entity applicationentity; AE
The activity elements in the application process contain a set of capabilities related to the open system interconnection (OSI) and defined for the application layer, corresponding to the characteristics Specify the type of application entity (not including redundant capabilities being used). [GB/T 9387.1-1998, definition 7.1.1.1]
3.2 Application framework
The media storage application framework defines the choices at different levels of the DICOM media storage model. This DICOM media storage is applicable The requirements and context of media exchange operations based on specific expectations. [DICOMPS3.10, definition 3.8]
......
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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