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GB/T 13797-2023 English PDF (GBT13797-2023)

GB/T 13797-2023 English PDF (GBT13797-2023)

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GB/T 13797-2023: General specifications for X-ray tube

This document defines the terms and definitions of medical X-ray tubes, and specifies the requirements and test methods for medical X-ray tubes. This document applies to medical X-ray tubes. Note: This product, used as the ray source of medical X-ray equipment, is assembled in the sleeve (X-ray tube assembly) that uses oil as the insulating and cooling medium; it is used for supporting medical X-ray equipment.
GB/T 13797-2023
GB
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 11.040.50
CCS C 43
Replacing GB/T 13797-2009
General specifications for X-ray tube
ISSUED ON: MARCH 17, 2023
IMPLEMENTED ON: APRIL 01, 2024
Issued by: State Administration for Market Regulation;
Standardization Administration of the PEOPLE Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Requirements ... 7
5 Test methods ... 12
Appendix A (Informative) Notes on some clauses ... 18
References ... 21
General specifications for X-ray tube
1 Scope
This document defines the terms and definitions of medical X-ray tubes, and specifies the requirements and test methods for medical X-ray tubes.
This document applies to medical X-ray tubes.
Note: This product, used as the ray source of medical X-ray equipment, is assembled in the sleeve (X-ray tube assembly) that uses oil as the insulating and cooling medium; it is used for supporting medical X-ray equipment.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the version corresponding to that date is applicable to this document; for undated references, the latest version (including all amendments) is applicable to this document. GB/T 1804, General tolerances - Tolerances for linear and angular dimensions without individual tolerance indications
GB/T 2423.1-2008, Environmental testing for electric and electronic products - Part 2: Test methods - Tests A: Cold
GB/T 2423.2-2008, Environmental testing for electric and electronic products - Part 2: Test methods - Tests B: Dry heat
GB/T 2423.3-2016, Environmental testing - Part 2: Testing method - Test Cab: Damp heat, steady state
GB/T 4798.2-2021, Classification of environmental conditions - Classification of groups of environmental parameters and their severities - Part 2: Transportation and handling
GB 9706.1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.228, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
GB/T 10149, Terminology and symbol for medical X-ray equipment
The overall dimensions of medical X-ray tubes shall be given by the manufacturer in the accompanying documents as diagrams, and the unmarked tolerances of the overall dimensions shall comply with the provisions of level V in GB/T 1804.
4.2.2 Electrode connection
The electrode connection diagram of medical X-ray tubes shall be given by the manufacturer in the accompanying documents.
4.3 Appearance and structure
4.3.1 Shell
The following requirements shall be met:
a) There shall be no opaque sand spots on the glass shell of the X-ray tube; the surface of the shell of other materials shall be smooth and clean without damage; b) There shall be no defects such as gas lines, bubbles and scratches in the X-ray window area of the glass bulb; there shall be no defects such as particles, cracks, scratches, grooves, and burrs in the X-ray window area of other materials. 4.3.2 Electrode surface
There shall be no damage affecting the performance of the electrode surface in the X- ray tube, and there shall be no foreign matter melted on the actual focal plane. 4.3.3 Foreign objects in the tube
There shall be no foreign objects in the X-ray tube that affect the normal work, such as movable metal particles, fibrous foreign objects.
4.4 Photoelectric performance
4.4.1 Nominal X-ray tube voltage
The nominal tube voltage of medical X-ray tubes shall be given by the manufacturer in the accompanying documents, which shall meet the requirements of YY/T 0064-2016. 4.4.2 Overvoltage
The X-ray tube shall be able to withstand 1.1 times the nominal X-ray tube voltage for 3 minutes, during which there shall be no abnormal discharge phenomena, such as flashover and breakdown.
If the nominal X-ray tube voltage of the X-ray tube in the fluoroscopy mode exceeds 80% of the nominal X-ray tube voltage in the photography mode, the X-ray tube shall also be able to withstand the nominal X-ray tube voltage of 1.1 times the fluoroscopy mode, for 15 min, during which there shall be no abnormal discharge phenomenon, such as flashover and breakdown.
4.4.3 Cathode emission characteristics
The cathode emission characteristics of medical X-ray tubes shall be given by the manufacturer in the accompanying documents, which shall comply with the requirements of YY/T 0064-2016.
4.4.4 Input power
4.4.4.1 Nominal anode input power
The nominal anode input power of the medical X-ray tube shall be given by the manufacturer in the accompanying documents, which shall comply with the requirements of YY/T 0064-2016.
4.4.4.2 Nominal photographic anode input power
The nominal photographic anode input power of the medical X-ray tube shall be given by the manufacturer in the accompanying documents, which shall comply with the requirements of YY/T 0064-2016.
4.4.4.3 Nominal CT anode input power
The nominal CT anode input power of the medical X-ray tube shall be given by the manufacturer in the accompanying documents, which shall comply with the requirements of YY/T 0064-2016.
4.4.4.4 CT scan power index (CTSPI)
The nominal CT scan power index (CTSPI) of the medical X-ray tube shall be given by the manufacturer in the accompanying documents, which shall comply with the requirements of YY/T 0064-2016.
4.4.4.5 Continuous anode input power
The continuous anode input power of the medical X-ray tube shall be given by the manufacturer in the accompanying documents, which shall comply with the requirements of YY/T 0064-2016.
Note: As the continuous anode input power is affected by the external environment, the manufacturer can give the boundary conditions of the continuous anode input power, such as oil temperature, cooling conditions.
4.4.4.6 Single rated load
The single rated load of the medical X-ray tube shall be given by the manufacturer in the accompanying documents.
The X-ray tube shall be subjected to the vibration test specified in 5.5.4. After the test, there shall be no mechanical damage by visual inspection. It shall work normally at the nominal X-ray tube voltage.
4.6 Expected service life
The manufacturer of the medical X-ray tube shall give the expected service life in the accompanying documents, and shall provide the corresponding verification documents. See Appendix A for more information on expected service life.
The expected service life shall be expressed in years or months or loading times or kilowatt-seconds (kW??s), and that for CT tube can be expressed in scan seconds (ss) or scan times.
If the expected service life is expressed in years or months, the basis shall be given in the accompanying documents.
4.7 Accompanying documents
4.7.1 General
Accompanying documents may be provided together with the X-ray tube; alternatively, they may be incorporated into the accompanying documents for any X-ray tube assembly equipped with the X-ray tube.
Where applicable, accompanying documents shall include the following:
-- name or trademark and contact information of the manufacturer for reference by the responsible party;
-- model or type reference number.
4.7.2 Instruction manual
The instruction manual for the X-ray tube shall state its intended use. The instruction manual shall specify the following data:
a) target material for determining the radiant energy spectrum;
b) target angle;
c) focus nominal value;
d) permanent filtration determined according to YY/T 0062, or thickness and chemical symbols of relevant materials;
e) nominal X-ray tube voltage specified in YY/T 0064-2016;
f) cathode emission characteristics specified in YY/T 0064-2016;
g) case voltage specified in YY/T 0064-2016, if applicable;
h) case current specified in YY/T 0064-2016, if applicable;
i) nominal anode input power specified in YY/T 0064-2016;
j) nominal photographic anode input power specified in YY/T 0064-2016, except for CT tubes;
k) nominal CT anode input power specified in YY/T 0064-2016, for CT tubes; l) nominal CT scan power index specified in YY/T 0064-2016, for CT tubes; m) continuous anode input power specified in YY/T 0064-2016;
n) single rated load specified in YY/T 0064-2016;
o) series rated load specified in YY/T 0064-2016, if applicable;
p) anode rotational speed, if applicable;
q) the limit value of the CT tube to the rotational speed or centrifugal force of the scanning gantry, if applicable;
r) main dimensions represented by diagrams, where the focus position and the accuracy of the position are shown;
s) the current cut-off characteristics of the gate-controlled X-ray tube, if applicable; t) the oil temperature and pressure limit for the operation of the X-ray tube, if applicable;
u) restrictions on transportation and storage conditions;
v) measures to be taken during the initial loading at the end of the X-ray tube installation and special procedures for training the X-ray tube;
w) necessary safety precautions.
4.8 Safety
The requirements of GB 9706.228 shall be met.
5 Test methods
5.1 Test conditions
During the test, if a slight corona discharge occurs in the high-voltage circuit, but stops when the test voltage drops to 100% of the voltage indicated by the test conditions, this discharge phenomenon may not be considered.
Note: Carry out the test under appropriate tube current conditions where the continuous anode input power of the X-ray tube is not exceeded.
5.4.3 Cathode emission characteristics
Check compliance by inspection of the accompanying documents.
5.4.4 Input power
5.4.4.1 Nominal anode input power
Check compliance by inspection of the accompanying documents and by the following tests.
Test the nominal anode input power in accordance with the provisions of YY/T 0064- 2016 under the X-ray tube voltage of 100 kV and the nominal X-ray tube voltage. For X-ray tubes whose nominal X-ray tube voltage is lower than 100 kV, test it in accordance with the provisions of YY/T 0064-2016 under the nominal X-ray tube voltage.
5.4.4.2 Nominal photographic anode input power
Check compliance by inspection of the accompanying documents and by the following tests.
Test the nominal photographic anode input power in accordance with the provisions of YY/T 0064-2016 under the X-ray tube voltage of 100 kV and the nominal X-ray tube voltage, respectively.
For X-ray tubes whose nominal X-ray tube voltage is lower than 100 kV, test it in accordance with the provisions of YY/T 0064-2016 under the nominal X-ray tube voltage.
The duration of each test condition is not less than 1 h, and each focus is tested separately.
5.4.4.3 Nominal CT anode input power
Check compliance by inspection of the accompanying documents and by the following tests.
Test the nominal CT anode input power in accordance with the provisions of YY/T 0064-2016 under the X-ray tube voltage of 120 kV and the nominal X-ray tube voltage, respectively.
The duration of each test condition is not less than 1 h, and each focus is tested separately.
5.4.4.4 CT scan power index (CTSPI)
Check compliance by inspection of the accompanying documents and by the following tests.
Select 1 s, 4 s, 10 s and 25 s in the nominal CT power curve, and test it in accordance with the provisions of YY/T 0064-2016 under the X-ray tube voltage of 120 kV and the nominal X-ray tube voltage, respectively.
Test each focus separately.
5.4.4.5 Continuous anode input power
Check compliance by inspection of the accompanying documents and by the following tests.
Test the continuous anode input power in accordance with the provisions of YY/T 0064- 2016 at the nominal X-ray tube voltage.
The test duration shall not be less than 2 h.
5.4.4.6 Single rated load
Check compliance by inspection of the accompanying documents and by the following tests.
Select at least 3 different loading times under the nominal X-ray tube voltage, and test according to the provisions of YY/T 0064-2016.
5.4.4.7 Series rated load
Check compliance by inspection of the accompanying documents and by the following tests.
Select at least 3 different loading conditions under the nominal X-ray tube voltage, and test according to the provisions of YY/T 0064-2016.
5.4.5 Focus nominal value
Check compliance by inspection of the accompanying documents and the following measurements.
Measure the focus size according to the provisions of YY/T 0063.
5.4.6 Exposure rate/air kerma rate
Appendix A
(Informative)
Notes on some clauses
A.1 General
This Appendix is used to clarify changes in normative references and the reasons why some clauses are no longer mentioned.
A.2 Notes on normative references
YY/T 0064-2016 covers the definition and conditions of X-ray tube-related electrical performance and load performance, and gives the description of these characteristics and the measurement methods; in order to avoid inconsistencies in definitions, terms and measurement methods, the terms and definitions of this document refer to GB 9706.1, GB 9706.228, GB/T 10149 and YY/T 0064-2016, and no longer refer to GB/T 2987, GB/T 4597, GB/T 12078 and GB/T 12079.
GB 9706.228-2020 replaces GB 9706.11-1997.
GB 9706.3-2000 is a special standard for the safety of high-voltage generators for diagnostic X-ray generators, and GB 9706.10-1997 is a special standard for the safety of therapeutic X-ray generators. The only requirements related to X-ray tubes are dielectric strength. GB 9706.228-2020 and the overvoltage (4.4.2) in this document already include the requirements for the dielectric strength of high-voltage circuits in GB 9706.3-2000 and GB 9706.10-1997, so this document no longer refers to GB 9706.3 -2000 and GB 9706.10-1997.
GB/T 4798.2-2021 replaces GB/T 2423.10-2008 and specifies specific conditions. SJ/T 10624-1995 only stipulates ?€?the loading power is not lower than the continuous power or 90% of a specific power?€? for the loading conditions of the test. Its test conditions are very different from the existing X-ray tubes, especially the clinical application parameters of high-power X-ray tubes. The test results cannot truly reflect the actual life of the X-ray tube, so this document no longer refers to this standard. This document deletes the naming, and SJ/T 10732-2000 is no longer used as a normative reference.
A.3 Notes on input power
Introduce the relevant characteristics of CT tube ?€? the requirements of nominal CT anode input power and CT scan power index (CTSPI).
Add nominal photographic anode input power and continuous anode input power. A.4 Notes on expected service life
A.4.1 General
This document replaces the working life with the expected service life, because the working life of the X-ray tube is not only affected by the quality of the X-ray tube itself, but also affected by the application of the whole machine system and the user?€?s usage habits, which are of a certain degree of uncertainty. Therefore, the actual working life of the X-ray tube may be longer or shorter than the stated life.
It is inappropriate to use a certain parameter to simulate the test and evaluate the expected service life of all X-ray tubes, especially high-power X-ray tubes, because it cannot truly reflect the actual life of X-ray tubes.
Therefore, it is acceptable for the X-ray tube manufacturer to submit relevant documents or reports to verify the self-declared expected service life of the X-ray tube. A.4.2 Test
A.4.2.1 Test method for expected service life
Whether the test is appropriate depends on many conditions. The manufacturer can formulate a suitable combination of loadable factors (such as the application scenario of the whole machine system, typical clinical application parameters, the proportion of different applications) according to the expected use of the X-ray tube to carry out the loading test. The justification for the test conditions used shall be mentioned together in the test report.
A.4.2.2 Statistical method of expected service life
If the manufacturer can obtain the clinical use data of the X-ray tube through the whole machine system (loading times or kilowatt-seconds or scan seconds or number of scans), the value of the expected service life can also be obtained through statistical analysis of the actual use data of the whole machine system.
A.5 Notes on the current cut-off characteristics of grid-controlled X-ray tube The characteristics of a specific X-ray tube, the requirements of which have been moved into the specification in this document.
A.6 Notes on the connection quality of parts, etc. that are not required Requirements -- for example, the connection of parts (including welding, bonding) shall be firm, and the sealing performance shall be good ?€? are the basic general requirements of product quality; therefore, the requirements for the connection of parts, the strength

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