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Functional and compatibility test methods for remote medical imaging equipment
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Basic data
| Standard ID | YY/T 1643-2018 (YY/T1643-2018) |
| Description (Translated English) | Functional and compatibility test methods for remote medical imaging equipment |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C30 |
| Classification of International Standard | 11.040 |
| Word Count Estimation | 19,167 |
| Date of Issue | 2018-12-20 |
| Date of Implementation | 2020-01-01 |
| Quoted Standard | DICOM PS3.2; DICOM PS3.4 |
| Regulation (derived from) | State Drug Administration Announcement No. 97 of 2018 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the basic functions, image compatibility and interoperability testing methods for remote medical imaging equipment conforming to the DICOM 3.0 standard. |
YY/T 1643-2018: Functional and compatibility test methods for remote medical imaging equipment
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(Functionality and compatibility test method for remote medical imaging equipment)
ICS 11.040
C30
People's Republic of China Pharmaceutical Industry Standard
Functionality and compatibility of remote medical imaging equipment
Testing method
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Test conditions 1
5 Basic function test method 1
6 DICOM file format compatibility test method 6
7 Interconnection test method 6
Appendix A (Normative) Requirements for DICOM Compliance Test Tools required for Interoperability Testing 15
Appendix B (informative) Interpretation of abbreviations and abbreviations 16
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee (SAC/TC10).
This standard was drafted. Shanghai Medical Device Testing Institute, Shanghai Lianying Medical Technology Co., Ltd., Shanghai Siemens Medical Devices Co., Ltd.
the company.
The main drafters of this standard. He Jun, Wang Shumei, Cao Jingtai, Liu Ruifei, Li Yong.
Functionality and compatibility of remote medical imaging equipment
Testing method
1 Scope
This standard specifies the basic functions, image compatibility and interconnection of remote medical imaging equipment conforming to the DICOM3.0 standard.
Sex test method.
Note 1. This standard is the test method standard. It does not require any function. The equipment manufacturer can use some or all of the items listed in this standard as needed.
Testing method.
2 Normative references
The following documents are indispensable 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.
DICOMPS3.2 Medical Digital Imaging and Communications (DICOM) Part 2. Declaration of Conformity (Digitalimagingand
Communicationsinmedicine(DICOM)-Part 2.conformance)
DICOMPS3.4 Medical Digital Imaging and Communications (DICOM) Part 4. Service Class Specification (Digitalimagingand
Communicationsinmedicine(DICOM)-Part 4.serviceclassspecifications)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Remote medical imaging equipment remotemedicalimagingequipment
A medical imaging device with information and data transmission function that complies with the DICOM 3.0 standard.
3.2
Patient management patientmanagement
Used to manage and display patient information stored in the system for patient data management.
4 test conditions
To meet Chapters 6 and 7 testing, device manufacturers are required to provide a DICOM Declaration of Conformity document. DICOM Declaration of Conformity
Please refer to DICOMPS3.2 for the specific requirements of the document.
5 basic function test method
5.1 Patient Management
5.1.1 Case Query Test Case
Test purpose. to detect whether the user can obtain the expected case by query.
...
