YY/T 1708.2-2020 English PDF

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YY/T 1708.2-2020: Basic requirements of communication and conformance for medical X-ray image equipment - Part 2: X-ray equipment for computed tomography
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1708.2-2020	629	Add to Cart	6 days	Basic requirements of communication and conformance for medical X-ray image equipment - Part 2: X-ray equipment for computed tomography	Valid

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Basic data

Standard ID: YY/T 1708.2-2020 (YY/T1708.2-2020)
Description (Translated English): Basic requirements of communication and conformance for medical X-ray image equipment - Part 2: X-ray equipment for computed tomography
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.50
Word Count Estimation: 34,380
Date of Issue: 2020-09-27
Date of Implementation: 2021-09-01
Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies): State Drug Administration

YY/T 1708.2-2020: Basic requirements of communication and conformance for medical X-ray image equipment - Part 2: X-ray equipment for computed tomography

---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 diagnostic X-ray imaging equipment-Part 2: X-ray computed tomography equipment) ICS 11:040:50 C43 People's Republic of China Pharmaceutical Industry Standard Connectivity of medical diagnostic X-ray imaging equipment Basic requirements for compliance Part 2: X-ray computed tomography equipment 2020-09-27 release 2021-09-01 implementation Issued by the State Drug Administration

Table of contents

Foreword Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements 5 4:1 Compatibility 5 4:1:1 DICOM compliance 5 4:1:2 Security software 8 4:2 Reliability 8 4:3 Cyber Security 8 4:3:1 Confidentiality 8 4:3:2 Integrity 8 4:3:3 Availability 8 4:3:4 Audit 8 4:3:5 Other additional requirements 9 4:4 Maintainability 9 4:5 Portability 9 5 Test method 9 5:1 Compatibility 9 5:2 Reliability 9 5:3 Cybersecurity 9 5:4 Maintainability 10 5:5 Portability 10 Appendix A (informative appendix) CT conformity declaration template 11

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: This part was proposed by the State Drug Administration: This part is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical X-ray Equipment and Apparatus Sub-Technical Committee (SAC/TC10/ SC1) Centralized: Drafting organizations of this section: Hangwei General Electric Medical Systems Co:, Ltd:, Shanghai Siemens Medical Devices Co:, Ltd:, Liaoning Medical Devices Equipment Inspection and Testing Institute, Medical Device Technology Evaluation Center of National Medical Products Administration, Shanghai United Imaging Medical Technology Co:, Ltd:, Shenyang Neusoft Medical Treatment Systems Co:, Ltd: The main drafters of this section: Xing Zhanfeng, Li Zhong, Wang Jianjun, Yang Pengfei, Huang Xiangyu, Ma Ruibing: Connectivity of medical diagnostic X-ray imaging equipment Basic requirements for compliance Part 2: X-ray computed tomography equipment

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 article Pieces: 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 applicationprofile 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] ......

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