YY/T 1708.6-2021Basic requirements of communication and conformance for medical X-ray image equipment - Part 6: X-ray unit for oral cavity (English PDF)
医用诊断X射线影像设备连通性符合性基本要求 第6部分：口腔X射线机
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Issued by
National Medical Products Administration of the People's Republic of China
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 1708.6-2021 is the English-translated version of 医用诊断X射线影像设备连通性符合性基本要求 第6部分：口腔X射线机.
YY/T 1708.6-2021 is the Chinese standard "Basic requirements of communication and conformance for medical X-ray image equipment - Part 6: X-ray unit for oral cavity".
Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — YY/T 1708.6-2021
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 4.1 Compatibility
- 4.1.1 DICOM Compliance
- 4.1.2 Security software
- 4.2 Reliability
- 4.2.1 Fault Tolerance
- 4.2.2 Resilience
- 4.2.3 Prevention of data loss
- 4.3 Cybersecurity
- 4.3.1 Confidentiality
- 4.3.2 Integrity
- 4.3.3 Availability
- 4.3.4 Audit
- 4.3.5 Other additional requirements
- 4.4 Maintainability
- 4.5 Portability
- 5 Test method
- 5.1 Compatibility
- 5.1.1 DICOM Compliance
- 5.1.2 Security software
- 5.2 Reliability
- 5.3 Cybersecurity
- 5.3.1 Confidentiality
- 5.3.2 Integrity
- 5.3.3 Availability
- 5.3.4 Audit
- 5.3.5 Other additional requirements
- 5.4 Maintainability
- 5.5 Portability
- Appendix A (Informative Appendix) Declaration of Conformity Template
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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
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Related Standards
GB/T 10149-1988 — Terminology and symbol for medical X-ray equipment
YY/T 1708.1-2020 — Basic requirements of communication and conformance for medical diagnostic X-ray image equipment - Part 1: General requirements
YY/T 1708.5-2021 — Basic requirements of communication and conformance for medical X-ray image equipment - Part 5: Mammography
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