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Particular specifications for computed radiography device
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| Standard ID | YY/T 0794-2022 (YY/T0794-2022) | | Description (Translated English) | Particular specifications for computed radiography device | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 27,244 | | Date of Issue | 2022-05-18 | | Date of Implementation | 2023-06-01 | | Older Standard (superseded by this standard) | YY/T 0794-2010 | | Drafting Organization | Liaoning Provincial Medical Device Inspection and Testing Institute, Shenzhen Feisen Technology Co., Ltd., Hubei Provincial Institute of Medical Device Quality Supervision and Inspection | | Administrative Organization | National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC 10/SC 1) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, classification and composition, requirements and test methods of image plate imaging devices for X-ray photography (hereinafter referred to as CR). This standard applies to CR equipment. This standard does not apply to non-CR imaging principle equipment. | | Standard ID | YY/T 0794-2010 (YY/T0794-2010) | | Description (Translated English) | Particular specifications for computed radiography device | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 22,227 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB 4793.1-2007; GB 7247.1-2001; YY/T 0291-2007; YY/T 0796-2010; DICOM 3.0; IEC 60788 | | Drafting Organization | Liaoning Provincial Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Medical electrical equipment | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the X-ray imaging with image plate imaging device (hereinafter referred to as CR) terms and definitions, composition, requirements and test methods. This standard applies to CR. The device uses the X- ray irradiation to form a " latent image " of the image board, the board by scanning the image of the " latent image " to form the digitized X-ray image. CR taken for X -ray equipment digitized form obtained diagnostic images, does not contain an X-ray imaging apparatus. |
YY/T 0794-2022
Particular specifications for computed radiography device
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0794-2010
Image plate imaging device for X-ray photography
Special technical conditions
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 2
4.1 Category 2
4.2 Composition 2
5 Requirements 2
5.1 Working conditions 2
5.2 Effective imaging area 3
5.3 bit depth 3
5.4 Imaging time 3
5.5 Number of IP boards processed per hour3
5.6 Threshold Contrast 3
5.7 Spatial Resolution 3
5.8 Image uniformity 3
5.9 Image Attenuation 3
5.10 Erase Completeness 4
5.11 Geometric Distortion 4
5.12 Software function 4
5.13 Noise 4
5.14 Appearance 4
5.15 Environmental test 4
5.16 Security 4
6 Test method 4
6.1 Test conditions 4
6.2 Effective imaging area 4
6.3 bit depth 5
6.4 Imaging time 5
6.5 Number of IP boards processed per hour5
6.6 Threshold Contrast 5
6.7 Spatial Resolution 5
6.8 Image uniformity 6
6.9 Image Attenuation 6
6.10 Erase Completeness 6
6.11 Geometric Distortion 7
6.12 Software functions 7
6.13 Noise 7
6.14 Appearance 7
6.15 Environmental test 7
6.16 Safety 7
Appendix A (Informative Appendix) Comprehensive Test Chart 8
Appendix B (Informative) Description of Threshold Contrast Test Phantom 9
Appendix C (Informative Appendix) Description of some clauses 18
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0794-2010 "Special technical conditions for image plate imaging devices for X-ray photography". and YY/T 0794-
Compared with.2010, the main technical changes except editorial changes are as follows.
--- Modified the applicable description in the scope of 1 (see Chapter 1, Chapter 1 of the.2010 edition);
--- Added 4.1 classification (see 4.1);
--- Modified the requirements for the effective imaging area in 5.2 (see 5.2, 5.2 of the.2010 edition);
--- Modified the requirements for threshold contrast in 5.6 (see 5.6, 5.6 of the.2010 edition);
--- Modified the requirements of 5.7 spatial resolution (see 5.7, 5.7 of the.2010 edition);
--- Modified the requirements for image attenuation in 5.9 (see 5.9, 5.9 of the.2010 edition);
--- Modified the 6.3 bit depth test method (see 6.3,.2010 edition 6.3);
--- Modified the test method for the number of IP boards processed per hour in 6.5 (see 6.5, 6.5 of the.2010 edition);
--- Modified the test method of 6.8 image uniformity (see 6.8,.2010 edition 6.8);
--- Modified the test method of 6.9 image attenuation (see 6.9,.2010 edition 6.9);
--- Modified the test method of 6.10 erasure completeness (see 6.10,.2010 edition 6.10);
--- Modified the description of 6.11 geometric distortion test card (see 6.11,.2010 edition 6.11);
--- Modified the description of the threshold contrast phantom in Appendix B (see Appendix B, Appendix B of the.2010 edition);
--- Added a description of the linearization data in Appendix C (see C.1.5).
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 standard is proposed by the State Drug Administration.
This standard 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 standard was drafted by. Liaoning Provincial Medical Device Inspection and Testing Institute, Shenzhen Feisen Technology Co., Ltd., Hubei Provincial Medical Device Quality Supervision
Supervision and Inspection Institute.
The main drafters of this standard. Jin Yubo, Lu Guangzhi, Baige.
The previous editions of the standard replaced by this standard are as follows.
---YY/T 0794-2010.
Image plate imaging device for X-ray photography
Special technical conditions
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements and tests of image plate imaging devices for X-ray photography (hereinafter referred to as CR).
test method.
This standard applies to CR equipment.
This standard does not apply to non-CR imaging principle equipment.
Note. CR uses an image plate that forms a "latent image" after X-ray irradiation, and forms a digital X-ray image by scanning the "latent image" on the image plate. For CR
The digitized diagnostic images are obtained after the X-ray equipment is photographed, and the X-ray equipment is not included.
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 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
GB 7247.1 Safety of Laser Products Part 1.Equipment Classification and Requirements
GB/T 10149 Terms and Symbols of Medical X-ray Equipment
GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
3 Terms and Definitions
GB/T 10149 and the following terms and definitions apply to this document.
3.1
Image plate imaging device for X-ray photography computedradiography; CR
The digital X-ray imaging technology using the image plate as the X-ray energy conversion medium is formed by laser scanning X-ray irradiation.
A "latent image" image plate, a device that obtains a digitized image.
3.2
imageplate
IP board
An X-ray receiver composed of materials with electron capture light storage and light-excited luminescence properties, the device is formed after X-ray irradiation
The "latent image" is scanned by a laser scanning device to obtain a digitized image.
3.3
bit-depth
quantization depth
For a given digitizing system, the range of pixel values (pixel) is expressed numerically in the form of bits.
......
YY/T 0794-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Particular specifications for computed radiography
device
ISSUED ON: DECEMBER 12, 2010
IMPLEMENTED ON: JUNE 01, 2012
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Composition ... 6
5 Requirements ... 6
6 Test method ... 9
Appendix A (Informative) Comprehensive test scale ... 14
Appendix B (Informative) Threshold contrast test phantom ... 16
Appendix C (Informative) Justification ... 28
Particular specifications for computed radiography
device
1 Scope
This standard specifies the terms and definitions, composition, requirements,
test methods of computed radiography device (hereinafter referred to as CR).
This standard applies to CR. The device uses an image plate that forms a
"latent image" after X-ray irradiation; forms a digital X-ray image by scanning
the "latent image" on the image plate. CR is used to obtain digital diagnostic
images after X-ray device photography, excluding X-ray photography device.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB 4793.1-2007 Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 1: General requirements
GB 7247.1-2001 Safety of laser products - Part 1: Equipment classification,
requirements and users guide
YY/T 0291-2007 Environmental requirements and test methods for medical
x-ray equipment
YY/T 0796-2010 Medical electrical device - Exposure index of digital X-ray
imaging system - Part 1: Definition and requirements of general X-ray
photography
DICOM 3.0 Medical digital imaging and communication standard (third
edition)
IEC 60788 Medical electrical device - Glossary of terms and definitions
3 Terms and definitions
The terms and definitions as defined in IEC 60788 as well as the following terms
and definitions apply to this document.
It is a phenomenon that the potential image information of X-ray photography
recorded by the IP plate decreases with time before being read.
4 Composition
CR is mainly composed of imaging plate, scanning device, control processing
device.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified in the product standard, the working environment
conditions of CR shall meet:
a) Ambient temperature: 10 °C ~ 40 °C;
b) Relative humidity: 30% ~ 75%;
c) Atmospheric pressure: 700 hPa ~ 1060 hPa.
5.1.2 Power supply conditions
The working power supply conditions of CR shall meet:
a) For the power supply voltage and the number of phases specified in the
product standard, the fluctuation of the grid voltage shall not exceed ±10%
of the nominal value;
b) Power frequency: 50 Hz ± 1 Hz (products for export are specified by the
manufacturer);
c) The power capacity as specified by the product standard.
5.2 Effective imaging area
The product standard shall specify the maximum size and deviation of the
effective imaging area of the IP plate in the X and Y directions; the deviation
shall not exceed ±5% of the nominal value.
5.3 Bit-depth
The product standard shall specify the bit-depth when the image is acquired; it
shall not be less than 12 bits/pixel.
Observe the exposed image of the specified test scale; there shall be no
geometric distortion of image.
5.12 Security of management information
There shall be software measures taken to ensure the privacy and reliability of
patient data.
5.13 Information management
There shall be software measures to manage patient information, at least with
the functions of registration, modification, deletion, query, statistics, backup
management.
5.14 Film printing
It has the function of transferring images to a film printer.
5.15 Medical digital imaging and communication standards
If it conforms to the DICOM 3.0 standard or other network communication
standards, it shall provide a compliance statement in the accompanying
documents.
5.16 Noise
The noise generated during operation under working conditions shall not
exceed 70 dB (A weighting network) (not including non-continuous and non-
periodic noise within 3 s).
5.17 Appearance
The appearance shall be neat and beautiful; the surface shall be smooth and
clean; color shall be uniform. There shall be no defects such as scars, cracks,
etc.
5.18 Environmental test
It shall meet the requirements of YY/T 0291-2007 (except IP plate). In the initial,
intermediate or final testing, the device shall be able to be used normally without
abnormal phenomena.
5.19 Safety
It shall meet the requirements of GB 4793.1-2007 and GB 7247.1-2001.
The test steps are as follows:
a) Select appropriate loading conditions, so that the X-ray irradiation field
covers the entire IP plate;
b) Under the conditions of the effective imaging area, pixel size and bit-depth
of the specified IP plate, measure the time from when the IP plate is placed
in the CR scanning device to the time when the image that can be used
for medical diagnosis is completely displayed on the display;
c) The effective imaging area, pixel size and bit-depth of the IP plate shall be
recorded together with the measurement results.
6.5 Number of IP plates processed per hour
The test steps are as follows:
a) Select five IP plates of the same specification;
b) Start timekeeping when the first IP plate is inserted into the card slot of
the CR scanning device, until the last IP plate is withdrawn from the CR.
The operation time shall be shortened as much as possible for the part of
the CR that requires manual operation;
c) Measure the total time required to complete the entire process of the IP
plate’s processing cycle for 5 consecutive times; calculate the number of
IP plates processed in 1 h; the result takes an integer.
6.6 Threshold contrast
Use the test method specified in the product standard for testing, or test
according to the following methods as recommended by this standard, the steps
are as follows:
a) Use the threshold contrast phantom in Appendix B and select appropriate
loading conditions, to obtain the clearest phantom image;
b) Refer to Appendix B, to obtain the reciprocal of the image quality value
through calculation;
c) Repeat steps a) ~ b) to measure 3 times; take the average value;
d) The measurement conditions, effective imaging area of the IP plate, pixel
size, bit-depth shall be recorded together with the results.
6.7 Spatial resolution
Load according to the loading conditions as specified in the product standard
or automatic exposure control; meanwhile adjust the brightness and contrast to
other similar test scales;
b) According to the loading conditions as specified in the product standard,
the X-ray’s irradiation field covers the entire IP plate; the reference axis
shall be perpendicular to the IP plate, to expose the IP plate;
c) Scan the image of the IP plate; make visual inspection; there is no obvious
geometric distortion.
6.12 Security of management information
Verify by checking the device.
6.13 Information management
Verify by checking the device.
6.14 Film printing
Verify by inspection.
6.15 Medical digital imaging and communication standards
Verify by checking its declaration of conformity.
6.16 Noise
The sound level meter’s probe is 1 m away from the surface of the CR system
and 1.5 m from the floor. The sound level meter "A" class weighting network is
used for measurement; use the maximum noise value for calculation.
6.17 Appearance
Observe visually.
6.18 Environmental test
It is performed according to the requirements of YY/T 0291-2007.
6.19 Security
The inspection shall be carried out according to the requirements of GB 4793.1-
2007 and GB 7247.1-2001.
Appendix C
(Informative)
Justification
C.1 Description about 3.1, 3.2, 3.3
Photostimulable Luminescence (PSL) is the basis of CR imaging. This feature
makes CR different from other medical imaging device.
The imaging layer in the IP plate is a layer of barium halide fluoride crystals
containing divalent europium ions. The compound in the crystal layer is
irradiated by X-rays; the fluorescent substance absorbs the incident X-rays and
stores its energy, forming a latent image and storing it in the crystal, which is a
simulated image (this is the first excitation); then the laser beam scans the
fluorescent screen with latent image (second excitation); the information stored
on the screen is radiated from the converted light signal. The wavelength of the
helium-neon laser beam used is 670 nm ~ 690 nm. The surface of the IP plate
is scanned sequentially in the direction perpendicular to the IP plate. The
phosphor refracted from the IP plate is excited by the secondary excitation
(called Photostimulable Luminescence, PSL), producing fluorescence. The
intensity of the fluorescence is precisely proportional to the latent image energy
at the first excitation. The fluorescence is collected and guided along the high-
efficiency light guide filmed by laser scanning; enters the photomultiplier tube;
is amplified by the A/D converter into a digital signal and stored on the computer.
The computer can further process the stored images and display them. The
signal on the storage screen can be erased by strong light for the next use.
CR does not include X-ray machines. Its main purpose is to replace the
traditional X-ray screen-film system, to realize the digital processing and
storage of diagnostic images.
C.2 Description of 3.4 and 3.5
For the specifications of the IP plate, its effective imaging area, bit-depth, pixel
size determines the image quality of X-ray digital images from the hardware.
C.3 Descriptions of 5.6
Image quality figure (IQF) is a method of quantifying images for threshold
contrast evaluation. The following methods can be used for threshold contrast
evaluation:
a) Draw a curve that passes through the threshold area, which is called the
contrast-detail curve.
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