YY/T 0794-2022 (YY/T0794-2022, YYT 0794-2022, YYT0794-2022)
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Particular specifications for computed radiography device
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YY/T 0794-2022
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Standards related to: YY/T 0794-2022
| 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Count Estimation | 27,244 | | Date of Issue | 2022-05-18 | | Date of Implementation | 2023-06-01 | | Older Standard (superseded by this standard) | YY/T 0794-2010 | | Drafting Organization | Liaoning Provincial Medical Device Inspection and Testing Institute, Shenzhen Feisen Technology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. | 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.
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