This standard specifies the terms, definitions, system composition, requirements and test methods of digital medical X-ray photography system (hereinafter referred to as DR system).
This standard is applicable to the DR system for which the general X-ray photography is used, including but not limited to those systems adopting linear array scanning or surface array scanning detectors:
——DR system which adopts flat-panel detector (FPD);
——DR system which adopts surface array CCD (charge-coupled device) detector;
——DR system which adopts linear array scanning CCD detector;
——DR system which adopts CMOS (complimentary metal oxide semiconductor) detector.
As for DR system which adopts more than one digital X-ray image detector, this standard is applicable to each digital X-ray image detector and the X-ray generation device used during imaging.
This standard is not applicable to the system which adopts X-ray image intensifier, computer X-ray photography system, and DR system of mammary gland X-ray device, dentistry X-ray device, computer tomography device and dual-energy image device.
2 Normative References
The following documents contain provisions which, through reference in this standard, become provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties who enter into agreement according to this standard are encouraged to research whether the latest editions of these documentations are applied or not. For undated references, the latest edition of the referenced document is applicable to these specifications.
GB 9706.1-2007 Medical Electrical Equipment-Part 1: General Requirements for Safety (IEC 60601-1:1988, IDT)
GB 9706.3-2000 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High-voltage Generators of Diagnostic X-ray Generators (idt IEC 60601-2-7:1998)
GB 9706.11-1997 Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis (idt IEC 60601-2-28:1993)
GB 9706.12-1997 Medical Electrical Equipment-Part 1: General Requirements for Safety III. Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment (idt IEC 60601-1-3:1994)
GB 9706.14-1997 Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment (idt IEC60601-2-32:1994)
GB 9706.15-2008 Medical Electrical Equipment-Part 1: General Requirements for Safety-III. Collateral Standard: Safety Requirements for Medical Electrical Systems (IEC 60601-1-1:2000, IDT)
GB/T 10149 Terminology and Symbol for Medical X-ray Equipment
GB/T 10151-2008 Medical X-ray Equipment-Specifications for High Voltage Cable Plug and Socket
GB/T 17857-1999 Medical Radiology-Terminology (Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry)
GB/T 19042.1-2003 Evaluation and Routine Testing in Medical Imaging Departments-Part 3-1: Acceptance Test-Imaging Performance of X-ray Equipment for Radiographic and Radioscopic Systems (IEC 61223-3-1: 1999, IDT)
YY/T 0106-2008 General Specifications for Medical Diagnostic X-ray Equipment
YY/T 0291-2007 Environmental Requirements and Test Methods for Medical X-ray Equipment
YY 0505-2005 Medical Electrical Equipment-Part 1-2: General Requirements for Safety-Collateral Standards: Electromagnetic Compatibility-Requirements and Tests (IEC 60601-1-2: 2001, IDT)
DICOM 3.0 The Digital Imaging and Communications in Medicine (the Third Edition)
3 Terms and Definitions
Except for the following terms and definitions, the terms and definitions established in GB/T 10149 and GB/T 17857 are applicable to this standard.
3.1
Digitizing X-ray imaging system
X-ray device which adopts digital X-ray image detector and consists of subsystem which is capable of carrying out image processing, display, printing or storage and providing digital format projection image.
3.2
Digital X-ray image device
Device consists of digital X-ray image detector, amplifying and digital circuit as well as computer which provides preliminary image data.
3.3
Digital radiography system
Device which adopts digital X-ray image detector technology to realize X-ray photography. It is a kind of digital X-ray imaging system, which generally consists of X-ray generation device, digital X-ray image device, control device and mechanical auxiliary device.
3.4
Digital X-ray image detector
Converter which converts the image information of light quantum form to digital electronic form after linear array or matrix pixel structure is adopted to carry out spatial sampling for X-ray figure.
3.5
Imaging time
Time required starting from exposure to the screen displaying required normal picture which meets the diagnosis.
3.6
Preview time
Time starts from exposure to the screen displays the complete image of the screened position.
3.7
Information management
Software measures which are taken to administrate the patients' information, such as reservation, registration, modification, deletion, enquiry, statistics and backup administration.
3.8
Sensitivity linearity
System linearity of image brightness variation generated by linear variation incident air kerma under specific illuminating condition.
3.9
Low contrast resolution
Lowest contrast detail object of specified shape and area which may be distinguished from a uniform background condition under specified measurement condition; expressed in %.
3.10
Limiting spatial resolution
Minimum spatial frequency line pair group of which the specified line set figure image is distinguishable with eyesight under specified measurement condition. The unit is lp/mm.
3.11
Flat uniformity
The difference of different zones responding to incident air kerma on the system image receiving surface.
