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YY/T 0481-2016: Medical diagnostic X-ray equipment--Radiation conditions for use in the determination of characteristics
Status: Valid YY/T 0481: Evolution and historical versions
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Medical diagnostic X-ray equipment--Radiation conditions for use in the determination of characteristics
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YY/T 0481-2016
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| YY/T 0481-2004 | English | 959 |
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Medical diagnostic X-ray equipment. Radiation conditions for use in the determination of characteristics
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Basic data | Standard ID | YY/T 0481-2016 (YY/T0481-2016) | | Description (Translated English) | Medical diagnostic X-ray equipment--Radiation conditions for use in the determination of characteristics | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 36,372 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | YY/T 0481-2004 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 0481-2016: Medical diagnostic X-ray equipment--Radiation conditions for use in the determination of characteristics
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0481-2004
Medical diagnostic X - ray equipment
Determination of the characteristics of radiation conditions
Radiationconditionsforuseinthedetermination of characteristics
(IEC 61267..2005, IDT)
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Scope and Purpose 1
2 normative reference document 3
3 Terms and definitions 3
4 General aspects --- Adjustment procedure 4
4.1 Standard Radiation Conditions 4
4.2 Radiation Detector 5
4.3 Rupture rate of X-ray tube voltage 5
4.4 anode material 5
5 RQR --- Radiation quality of radiation beam from X-ray tube assembly 5
5.1 Purpose 5
5.2 Characteristic expression 5
5.3 Description 5
5.4 X-ray tube voltage adjustment 6
5.5 Additional filter 6
5.6 Test equipment 6
5.7 Generation and verification of standard radiation quality RQR 7
6 RQA --- Radiation quality of mold body based on aluminum additional filter plate 8
6.1 Purpose 8
6.2 Characteristics of the statement 9
6.3 Description 9
6.4 Production of standard radiation quality RQA 9
6.5 Alternative methods for generating standard radiation quality RQA 10
RQC --- radiation quality based on copper additional filter plate 11
7.1 Purpose 11
7.2 Characteristics of the statement 11
7.3 Description 11
7.4 Method for generating radiation quality RQC 11
8 RQT --- radiation quality based on copper additional filter plate 12
8.1 Purpose 12
8.2 Characterization 12
8.3 Description 12
8.4 Method for generating radiation quality RQT 12
8.5 Alternatives to Generate Standard Radiation Quality RQT
8.6 Half price test device 13
9 Standard Radiation Conditions RQN 13
9.1 Purpose 13
9.2 Features Presentation 13
9.3 Description 13
9.4 Test equipment (diaphragm) 14
9.5 Production of standard radiation conditions RQN 15
10 Standard Radiation Conditions RQB 17
10.1 Purpose 17
10.2 Features Presentation 17
10.3 Description 17
10.4 Test equipment (diaphragm) 17
10.5 Production of standard radiation conditions RQB 17
11 Standard Radiation Conditions RQR-M 17
11.1 Purpose 17
11.2 Characteristic Expression 18
11.3 Description 18
11.4 Generation of standard radiation mass RQR-M 18
12 Standard Radiation Conditions RQA-M 18
12.1 Purpose 18
12.2 Characteristic Expression 18
12.3 Description 18
12.4 Production of standard radiation quality RQA-M 19
13 Standard Radiation Conditions RQN-M 19
13.1 Purpose 19
13.2 Characteristic Expression 19
13.3 Description 19
13.4 Test equipment (diaphragm) 20
13.5 Production of standard radiation conditions RQN-M 20
14 Standard Radiation Conditions RQB-M 21
14.1 Purpose 21
14.2 Characteristic Expression 21
14.3 Description 21
14.4 Test equipment (diaphragm) 21
14.5 Production of standard radiation conditions RQB-M 22
Appendix A (informative appendix) Reason statement 23
Appendix B (informative) Determines the amount of additional filtration
Appendix C (informative) Practical peak voltage measurement
Appendix D (informative) Summary of Radiation Quality and Radiation Conditions
Reference 28
Index 29
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0481-2004 "Radiation conditions for the determination of characteristics of medical diagnostic X-ray apparatus", and YY/T 0481-
2004 compared to the main technical changes as follows.
--- the introduction of the "practical peak voltage" to measure the X-ray tube voltage;
- the introduction of a new process of establishing radiation quality;
- Added information on Appendix B "Determining the amount of additional filtration" and informative Appendix C, "Practical peak voltage measurements";
--- updated the radiation quality and radiation conditions;
--- Added terms and definitions.
This standard uses the translation method equivalent to the use of IEC 61267..2005 "medical diagnostic X-ray equipment to determine the characteristics of radiation conditions."
For ease of use, this standard has been modified as follows.
--- "10 and 11" in the contents of column 5 of the 6th and 7th lines (corresponding to clauses 9 and 10) in the table of Appendix D are revised to
"9 and 10";
--- According to the description of 10.5, the distance from the application plane of the mold body in Fig. 4 to the application plane is changed from 2mm to 20mm.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Appliances Standardization Technical Committee of Radiation Therapy, Nuclear Medicine and Radiation Dosing Equipment Subcommittee
(SAC/TC10/SC3).
The main drafting of this standard. Beijing Medical Device Testing Institute, China Institute of Metrology, Beijing General Electric Warren medical equipment
Co., Ltd., Liaoning Province Medical Device Testing Institute.
The main drafters of this standard. Zhang Xin, Hu Guangyong, Zhang Zhaoyuan, Xie Shibing, Guo Bin, Ding Zhimin, Gao Bing.
This standard replaced the previous version of the standard release.
--- YY/T 0481-2004.
Introduction
In order to obtain a radiation beam suitable for use in physical and medical tests, or to determine the characteristics, performance or condition of the auxiliary equipment, a series of definitions
Clear radiation conditions, these radiation conditions can provide an important tool in many cases.
From the point of view of rules and standards,
--- with the international common, used to regulate the operating standards of X-ray equipment, the definition of clear radiation conditions;
- to provide a basis for coordinating existing national standards;
- to meet the needs of manufacturers, users, patients and health protection management agencies to provide a unified series of radiation conditions (ie, a
Radiation conditions library) to describe and determine the performance of X-ray equipment;
- To provide an internationally recognized definition and test method to address the communication between manufacturers, users and regulatory agencies.
From an application point of view, a series of generally acceptable radiation conditions are broadly used to.
--- quality control tests conducted by the manufacturer;
--- installation and acceptance test;
--- calibration of test equipment;
--- stereotypes test (if required);
- inspection and testing conducted by the governing body and the testing agency;
Physical and medical research done in physical laboratories and medical laboratories;
Determination of the characteristics of ancillary equipment.
Standard radiation conditions may also benefit potential users, for example.
--- manufacturer of X-ray equipment;
--- manufacturer of X-ray testing equipment;
--- research laboratory;
---testing facility;
---user;
--- government administration;
--- service organization;
--- standardization organization.
Some of the terms and descriptions of this standard require additional information, which is given in Appendix A, "Reason Description", and for those in the standard
The name on the left has an asterisk terms and subkeys to provide additional information.
In this standard, the measured peak voltage is measured as the X-ray tube voltage. Appendix C gives the reason for using the practical peak voltage.
Appendix C also gives a method for measuring the utility peak voltage.
During the development of this edition of the standard, a lot of work has been done to establish such a procedure that can be achieved on different X-ray machines
Highly equivalent standard radiation quality.
In the first edition of the standard, the X-ray tube voltage at the desired half-valence layer is adjusted by adjusting the X-ray tube voltage within a given limit
Radiation quality. The selected X-ray tube voltage may deviate from the nominal voltage by ± 5%, depending on the total intrinsic filtration. If the inherent filter phase
For strong, you can choose a low X-ray tube voltage to compensate, and vice versa. For example, for a nominal X-ray tube voltage
100kV radiation quality, this process shows that for moderate filtration of the radiation quality, the tube voltage can be selected at least 95kV, for severe
Filtration of the X-ray tube, tube voltage up to optional 105kV. As long as the two radiation quality has the required half price, it is considered both
Equivalent.
The above solution is not an ideal method. However, since there is no suitable and well-defined definition of the term for peak voltage,
There is no other alternative method. With the emergence of practical peak voltage, the situation has changed. the use of practical peak voltage this amount,
By means of voltage measurement, it is possible to cause the ray tube to be connected to an X-ray having a desired tube voltage and having an arbitrary waveform ripple
And the ray tube connected to the true constant voltage generator has the same low contrast as the "correct" voltage.
Considering the possibility of setting the "correct" voltage for any generator, regardless of the voltage waveform, it is difficult to precisely select the "wrong" tube voltage to
Above or below the average filtration of the X-ray tube. The procedures for implementing the radiation quality in this version of the standard include setting for the X-ray tube
"Correct" tube voltage, and to produce the required half-price layer to determine the amount of filtration required. The essence of this process means that there is one
The total inherent filtration, beyond this filtration, can not be used to produce a given radiation quality. This is not a new principle, but at this
Version of the standard in a clear description. In order not to exclude the so-called standard X-ray tube, some of the radiation quality of the half-price layer.
The new half-price selection makes it possible to use an X-ray tube with 2.5 mm Al hardening equivalent and an anode angle of not less than 9 °, which may be used to establish this standard
All the radiation quality.
The process of generating the RQR series of radiation quality given in this standard requires additional work. After more reproducible radiation quality is produced,
Can offset or reduce this additional workload. The greatest advantage of the new method is the given radiation produced by X-ray tubes with different intrinsic filters
Shot quality, with a higher degree of equivalence.
Medical diagnostic X - ray equipment
Determination of the characteristics of radiation conditions
1 scope and purpose
This standard applies to medical diagnostic X-ray equipment systems or components of the characterization test procedures, the procedure requires the definition of a clear radiation
condition.
In addition to mammography, this standard does not apply to the purpose of improving the characteristics of the radiation beam and deliberately selected with a discontinuous radiation absorption element
(For example, using a rare earth filter).
The radiation conditions measured with the sensitivity of the screen-chip system are not included in this standard.
Note. Screen-chip system optics is the subject of the ISO 9236 series of standards.
This standard deals with the use of what radiation conditions to produce radiation beams, which are commonly used by test laboratories or manufacturers
Test conditions for the determination of the characteristics of medical diagnostic X - ray equipment.
For example, those radiation masses are derived from the X-ray tube assembly and filtered by the radiation beam. With a scatter from the surface of the patient
Radiation conditions represent more general conditions. These need to define a clear geometric arrangement.
The most complete technical description of the radiation field is given by the spectral distribution of the luminous flux. Since measuring X-ray spectrum is a demanding task,
This standard uses X-ray tube voltage, the first half-valence layer and the second half-valence layer to represent the radiation quality. For the radiation conditions, but also attached to the body
Characteristics and geometric conditions to elaborate.
Try to use only the X-ray tube voltage, the first half price layer, and possibly the second half price layer, to describe the radiation beam spectrum distribution,
Conflicting between two conflicting requirements. Avoiding excessive work and establishing radiation quality without blurring when establishing radiation quality
the concept of. Due to the X-ray tube anode angle, the degree of anode roughening and the inherent design and use of different filtration time, the two radiation quality
Even with the same first half-valence layer and produced at the same X-ray tube voltage, the radiation beam spectrum distribution may still have a large difference. test
Considering the inherent ambiguity of the description of the radiation quality characteristics, the values (such as the X-ray tube voltage and the first half-valence layer) range allow the introduction of the tolerance
Shall be small enough to affect the application of this standard. This standard is to ensure that radiation quality or radiation conditions are consistent with the use of this standard
The measurement of the diagnostic device properties should produce a consistent result.
To this end, in the previous version of the standard working framework, some of the degrees of freedom to establish a radiation condition are removed. The substance of this standard is limited
Is the value that measures the tube voltage and sets it to "correct". The second step is to insert the required additional filtering in the beam in order to establish the description of the first
Half price layer. If the inherent filtering of the X-ray tube itself is so strong that the half-price of the rays emitted from the X-ray tube assembly is larger than the
, The X-ray tube assembly is not suitable for producing the desired radiation conditions. The anode angle of the X-ray tube assembly is too small and/or ray
This may occur when the aging of the tube causes the anode to be too rough.
In the following two paragraphs, the X-ray tube voltage has a decisive effect. Therefore, the occurrence of high voltage of the X-ray tube is not considered
Type of device, it is critical to choose the correct X-ray tube voltage. This approach is implemented in this standard by using a practical peak voltage
To measure the X-ray tube voltage. This voltage value is the weighted average of all X-ray tube voltage values during exposure. Regardless of the generator
Waveform, the weight is determined by the fact that the equivalent peak voltage produces the same low contrast value at the time of imaging.
Although the practical peak voltage can be measured using non-access measurements, the level of uncertainty required by this standard requires access measurement.
The design and aging of X-ray tube assemblies affect the results of non-access measurements. And when using the access measurement of practical peak voltage, X-ray
The design type and aging of the tube does not affect the measurement.
Within the physically viable framework, the difference between the design and aging of the tube is considered by adding an appropriate amount of auxiliary filtration.
Appendix C gives a more introduction to the practical peak voltage.
This standard describes two kinds of radiation conditions, that is, in a better approximation can ignore the radiation radiation of the primary radiation conditions (RQR, RQA,
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