YY/T 1708.6-2021 English PDF

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YY/T 1708.6-2021: (Basic requirements for some properties of medical diagnostic X-ray imaging equipment Chapter 6: Dental X light machine)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1708.6-2021	599	Add to Cart	5 days	(Basic requirements for some properties of medical diagnostic X-ray imaging equipment Chapter 6: Dental X light machine)	Valid

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Basic data

Standard ID: YY/T 1708.6-2021 (YY/T1708.6-2021)
Description (Translated English): (Basic requirements for some properties of medical diagnostic X-ray imaging equipment Chapter 6: Dental X light machine)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Word Count Estimation: 30,379
Issuing agency(ies): State Drug Administration

YY/T 1708.6-2021: (Basic requirements for some properties of medical diagnostic X-ray imaging equipment Chapter 6: Dental X light 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 Chapter 6.Dental X light machine) ICS 11.040.50 C43 People's Republic of China Pharmaceutical Industry Standard Medical diagnostic X-ray imaging equipment connectivity Compliance with basic requirements Part 6.Oral X-ray machine X-rayimageequipment-Part 6.X-rayunitfororalcavity 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 4.1.1 DICOM Compliance 3 4.1.2 Security software 6 4.2 Reliability 6 4.2.1 Fault Tolerance 6 4.2.2 Resilience 6 4.2.3 Prevention of data loss 6 4.3 Cybersecurity 6 4.3.1 Confidentiality6 4.3.2 Integrity 6 4.3.3 Availability 6 4.3.4 Audit6 4.3.5 Other additional requirements6 4.4 Maintainability 6 4.5 Portability7 5 Test method 7 5.1 Compatibility7 5.1.1 DICOM Compliance 7 5.1.2 Security software 7 5.2 Reliability7 5.3 Cybersecurity7 5.3.1 Confidentiality7 5.3.2 Integrity 7 5.3.3 Availability 7 5.3.4 Audit7 5.3.5 Other additional requirements 7 5.4 Maintainability7 5.5 Portability 7 Appendix A (Informative Appendix) Declaration of Conformity Template 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 6 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. Kawa Shengbang (Shanghai) Dental and Medical Devices Co., Ltd., State Drug Administration Medical Device Technical Review Center, Liaoning Medical Device Inspection and Testing Institute, Shenzhen Feisen Technology Co., Ltd., Sichuan Food and Drug Review and Evaluation and Safety Monitoring center. The main drafters of this section. Niu Bo, Zhang Qing, Zhang Longda, Lu Guangzhi, Liu Wei. Medical diagnostic X-ray imaging equipment connectivity Compliance with basic requirements Part 6.Oral X-ray machine

1 Scope

This part of YY/T 1708 specifies the terms and definitions, requirements and experiment method. This section applies to oral X-ray machines and their related software components. This section does not apply to oral X-ray 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 10149 Terms and Symbols of Medical X-ray Equipment YY/T 1708.1-2020 Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment Part 1.General requirements

3 Terms and Definitions

GB/T 10149 and the following terms and definitions apply to this document. 3.1 Oral X-ray machine X-rayunitfororalcavity The general term for oral and maxillofacial cone beam computed tomography equipment, oral curved tomography machine and dental X-ray machine. Note. Rewritten from YY/T 0010-2008, definition 3.1. 3.2 Application entity applicationentity; AE An active 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 application entity type (excluding redundant capabilities in use). [GB/T 9387.1-1998, definition 7.1.1.1] 3.3 association A partnership between entity calls. [GB/T 9387.1-1998, definition 5.3.1.1] 3.4 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. ......

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