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YY/T 1708.3-2021 English PDF

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YY/T 1708.3-2021: (Basic requirements for some properties of medical diagnostic X-ray imaging equipment - Part 3: Digital photography X-ray machine)
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1708.3-2021619 Add to Cart 5 days (Basic requirements for some properties of medical diagnostic X-ray imaging equipment - Part 3: Digital photography X-ray machine) Valid

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Basic data

Standard ID: YY/T 1708.3-2021 (YY/T1708.3-2021)
Description (Translated English): (Basic requirements for some properties of medical diagnostic X-ray imaging equipment - Part 3: Digital photography X-ray machine)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Word Count Estimation: 31,321
Issuing agency(ies): State Drug Administration

YY/T 1708.3-2021: (Basic requirements for some properties of medical diagnostic X-ray imaging equipment - Part 3: Digital photography X-ray 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 some properties of medical diagnostic X-ray imaging equipment Part 3.Digital photography X-ray 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 3.digital photographic X-ray machines 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 4 4.1 Compatibility4 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 8 5.5 Portability 8 Appendix A (Informative Appendix) DR Declaration of Conformity Template 9

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. 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. Shanghai Siemens Medical Equipment Co., Ltd., Shenzhen Shentu Medical Imaging Equipment Co., Ltd., Shanghai United Imaging Medical Medical Technology Co., Ltd., Liaoning Provincial Medical Device Inspection and Testing Institute. The main drafters of this section. Cao Jingtai, Rao Yuming, Xiang Jun, Sun Zhiyong. Medical diagnostic X-ray imaging equipment connectivity compliance Basic requirements part 3.digital photographic X-ray machines

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 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 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 applicationprofile 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]
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