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YY/T 1708.4-2021: (Basic requirements for the connectivity of diagnostic X-imaging equipment Chapter 4: Digital imaging description X-imaging extension)
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(Basic requirements for the connectivity of diagnostic X-imaging equipment Chapter 4: Digital imaging description X-imaging extension)
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YY/T 1708.4-2021
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Basic data | Standard ID | YY/T 1708.4-2021 (YY/T1708.4-2021) | | Description (Translated English) | (Basic requirements for the connectivity of diagnostic X-imaging equipment Chapter 4: Digital imaging description X-imaging extension) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 32,325 | | Issuing agency(ies) | State Drug Administration | YY/T 1708.4-2021: (Basic requirements for the connectivity of diagnostic X-imaging equipment Chapter 4: Digital imaging description X-imaging extension)
---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.
(Basic requirements for the connectivity of diagnostic X-imaging equipment Chapter 4.Digital imaging description X-imaging extension)
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Medical diagnostic X-ray imaging equipment connectivity compliance
Basic requirements part 4.digital subtraction angiography
X-ray machine
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 3
4.1 Compatibility3
4.2 Reliability7
4.3 Cybersecurity7
4.4 Maintainability 8
4.5 Portability 8
5 Test method 8
5.1 Compatibility8
5.2 Reliability 8
5.3 Cybersecurity 8
5.4 Maintainability 9
5.5 Portability 9
Appendix A (Informative) Digital Subtraction Angiography (DSA) DICOM Declaration of Conformity Template 10
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.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC10/SC1)
focal point.
This section is drafted by. Canon Medical Systems (China) Co., Ltd., Medical Device Technology Evaluation Center of the State Drug Administration,
Lepu (Beijing) Medical Equipment Co., Ltd., Siemens (Shenzhen) Magnetic Resonance Co., Ltd., Liaoning Medical Device Inspection and Testing Institute.
The main drafters of this section. Li Wei, Zhang Yujing, Zhou Xiucheng, Kang Jie, Xiao Yahui, Zhao Jiayang.
Medical diagnostic X-ray imaging equipment connectivity compliance
Basic requirements part 4.digital subtraction angiography
X-ray machine
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 article
pieces. 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]
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