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YY/T 1708.5-2021: (Basic requirements for connectivity of medical X-ray imaging equipment - Part 5: Diagnostic X-ray imaging machine)
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(Basic requirements for connectivity of medical X-ray imaging equipment - Part 5: Diagnostic X-ray imaging machine)
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Basic data | Standard ID | YY/T 1708.5-2021 (YY/T1708.5-2021) | | Description (Translated English) | (Basic requirements for connectivity of medical X-ray imaging equipment - Part 5: Diagnostic X-ray imaging machine) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 30,335 | | Issuing agency(ies) | State Drug Administration | YY/T 1708.5-2021: (Basic requirements for connectivity of medical X-ray imaging equipment - Part 5: Diagnostic X-ray imaging machine)
---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 connectivity of medical X-ray imaging equipment.Part 5.Diagnostic X-ray imaging machine)
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Medical diagnostic X-ray imaging equipment connectivity compliance
Basic requirements part 5.mammography machine
imageequipment-Part 5.Mammography
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 3
4.1 Compatibility3
4.2 Reliability 6
4.3 Cybersecurity 6
4.4 Maintainability7
4.5 Portability7
5 Test method 7
5.1 Compatibility7
5.2 Reliability7
5.3 Cybersecurity7
5.4 Maintainability7
5.5 Portability 7
Appendix A (Informative Appendix) Declaration of Conformity of Breast Implants 8
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 5 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. Philips (China) Investment Co., Ltd., Shanghai United Imaging Medical Technology Co., Ltd., Liaoning Province Medical Device Inspection
Testing Institute, Liaoning Provincial Drug Device Evaluation and Monitoring Center, Zhejiang Anzhen Medical Technology Co., Ltd.
The main drafters of this section. Ge Xin, Zhong Can, Wei Jingfeng, Chen Fujun, Zhang Junyi.
Medical diagnostic X-ray imaging equipment connectivity compliance
Basic requirements part 5.mammography machine
1 Scope
This part of YY/T 1708 specifies mammography machine (hereinafter referred to as mammography machine) 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 mammography equipment and its
Related software components.
This section does not apply to mammography machines and their related cameras that do not have the function of storing digital media and transmitting health data through the network.
Close the 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 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
The terms and definitions defined in GB/T 10149 and the following apply to this document.
3.1
conformance statement conformancestatement
A formal statement corresponding to a specific DICOM standard implementation. It specifies the service classes, information objects, communication
Communication protocol and media storage application framework.
[DICOMPS3.2, definition 3.11.1]
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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