This standard applies to medical diagnostic X-ray generators with an operating voltage of 10 to 150 kV. This standard does not apply to X-ray generators for computed tomography. GB 4505-1984 General Technical Requirements for Medical Diagnostic X-ray Generators GB4505-1984 Standard download decompression password: www.bzxz.net

National Standard of the People's Republic of China
Medical diagnostic X-ray generating unit
General technical conditions
The general specifications onmedical dagnostic X-ray generating unitUDC 615.471 : 389
GB4505—84
This standard applies to medical diagnostic X-ray generating units with an operating voltage of 10 to 150 kV. This standard does not apply to X-ray generating units for computed tomography.
1 Nouns and terms
1.1 X-ray generating unit
A combination of all components provided for the generation and control of X-ray radiation. 1.2 Transformer type X-ray generating unit
Refers to an X-ray generating unit in which the connection between the X-ray tube head assembly and the high-voltage generator is realized by a high-voltage cable and there is no energy storage capacitor in the high-voltage circuit.
1.3 Capacitive X-ray generator
is the abbreviation of capacitor discharge type X-ray generator. It generally refers to an X-ray generator with energy storage capacitors in the high-voltage circuit to supply the energy required for X-ray photography.
1.4 Combined X-ray generator
refers to an X-ray generator in which an X-ray tube, a high-voltage transformer, a filament transformer and a high-voltage rectifier are assembled as an integral component. 1.5 Non-sinusoidal X-ray generator
refers to an X-ray generator in which the working voltage of the high-voltage transformer of the X-ray generator is a non-sinusoidal voltage. For example: an X-ray generator that uses a battery pack as energy or a capacitor bank that obtains energy by direct rectification from the power frequency power grid as a working energy source is a non-sinusoidal X-ray generator.
1.6 X-ray controller
In order to control the working voltage, working current and photography and perspective process of the X-ray tube, all necessary and auxiliary components are integrated into certain electrical devices. The overall component composed of these devices is called a line controller. 1.7 Nominal tube voltage
refers to the maximum working voltage of the X-ray generator under certain conditions. It can be divided into fluoroscopic nominal tube voltage and photographic nominal tube voltage. The unit of nominal tube voltage is dry volt peak value, codenamed kV. 1.8 Nominal tube current
refers to the maximum value of the tube current corresponding to the nominal output of the X-ray generator and limits it. The nominal tube current is calculated as the average value of milliamperes per cycle, unit is milliamperes, codenamed mA. 1.9 Output power and nominal output of X-ray generator 1.9.1 Output power
The output power of X-ray generator is calculated by the following formula: P=U·IF10-3
Wherein: P—output power of X-ray generator, kW, U—operating voltage of X-ray tube, kV,
I—current value of X-ray tube, mA:
National Bureau of Standards 1984-06-22 Issued
1985-02-01 Implementation
GB 4505--84
Waveform factors related to the voltage waveform of X-ray tube. The waveform factors are selected according to the provisions of Table 1. Table 1
Tube voltage pulsation rate
>10% and <25%
1.9.2 Nominal output
Single-phase X-ray generator
3-phase 6-tube rectifier X-ray generator
3-phase 12-tube rectifier X-ray generator
According to the provisions of Article 1.8, when the working current of the X-ray tube is the nominal tube current, the power output determined by the maximum operating voltage allowed by the X-ray tube under this tube current is the nominal output of the X-ray generator. 1.10 Photographic parameter automatic control system
In the process of photography, the device assembly that can adjust and control more than one exposure factor is called a photographic parameter automatic control system. 1.11 Exposure factor combination
The three parameters that determine the X-ray output during photography: kV, mA and s are called exposure factors. A group of values ​​selected to meet a specific photography requirement is called an exposure factor combination. 1.12 Reference voltage
Inside the X-ray controller, the control voltage value directly taken from the output of the power supply regulating transformer. 2
Classification and series
Medical diagnostic X-ray generators are divided into four categories according to their structures: transformer-type X-ray generators, capacitor-type X-ray generators, combined X-ray generators and non-sinusoidal X-ray generators. For example, devices or components of soft-ray photography should meet the requirements of the corresponding categories and series except for the tube voltage adjustment range.
2.1 Transformer-type X-ray generators
Transformer-type X-ray generators are distinguished by the number of phases and nominal output of the power supply. Its series are shown in Table 2. Table 2
Number of power supply phases
Single phase or two phase
Nominal output kw
Nominal tube voltage
100 or 125
100 or 125
100 or 125
125 or 150
Nominal tube current range
100~200www.bzxz.net
300~500
300~500
500~1000
1000~1250
2.2 Capacitive X-ray generator
GB4505—84
Capacitive X-ray generators are distinguished by the capacity of the high-voltage energy storage capacitor. The unit is microfarad, and its series is shown in Table 3. Table 3
Capacitance μF
2.3 Combined X-ray Generator
Nominal tube voltage kv
100~125
mAs range
Combined X-ray generators are distinguished by their working range. X-ray generators for conventional fluoroscopy and photography are universal; X-ray generators that are only suitable for a specific inspection range are special-purpose. Its series is shown in Table 4. Table 4
Universal
Special-purpose
Nominal tube voltage kv
Special for photography>60
Special for fluoroscopy≥75
Nominal output kW
2.4 Non-sinusoidal X-ray generators can refer to the provisions of Tables 2 and 4 respectively according to their different structures and uses. 3 Working conditions
3.1 Environmental conditions
3.1.1 The ambient temperature is 15~35℃.
3.1.2 The relative humidity is 45%~75%.
3.1.3 The atmospheric pressure is 860~1060 mbar. 3.1.4 There is no corrosive and explosive gas or dust. 3.2 Power supply conditions
3.2.1 The power supply voltage and the allowable apparent internal resistance value used by various types of X-ray generating devices are shown in Table 5. When the nominal output power of the X-ray generating device is different from the series value specified in Table 5, the allowable apparent internal resistance value of its power supply should be the power supply apparent internal resistance value specified by the smaller capacity in the series value closest to this device. 124
Transformer type
Capacitor type
Combined type
Non-sinusoidal type
Nominal output
or capacity kW
According to Table 2 and Table 4
GB 4505-84
Power supply internal resistance
Three-phase two-wire
Recommended minimum power supply capacity
The fluctuation range of power supply voltage is 90%~110%. 3.2.2
3.2.3The nominal voltage frequency of power supply is 50Hz (including the charging power supply of non-sinusoidal X-ray generator), and the frequency value varies from 49.5~50.5Hz.
3.2.4The non-sinusoidal distortion of power supply voltage shall not exceed 2% of its amplitude. 3.2.5Each X-ray generator shall be equipped with a dedicated power supply operation switch and overload protection device. 3.2.6 Except for capacitive and non-sinusoidal X-ray generators, X-ray generators shall not be used in parallel with electrical equipment that can cause a 10% fluctuation in the power supply voltage of the X-ray generator. 3.2.7 The power supply should be equipped with a grounding terminal that is different from the neutral point of the power grid and directly connected to the earth. The grounding resistance should not be greater than 59.125
Technical requirements
4.1X-ray parameter configuration
4.1.1Parameter adjustment method
GB 4505--84
Except for the automatic adjustment system, the adjustment method of X-ray parameters can be continuous adjustment or step adjustment. The step adjustment method can adopt arithmetic series distribution and geometric series distribution. The geometric series distribution recommended by this standard is the R10 priority number system.
4.1.2 Tube voltage
The adjustment range of tube voltage shall not be less than that specified in Table 6. Table 6
Transformer type
(single phase or three phase two wire)
Transformer type
(three phase two wire or three phase)
Capacitor type
Combination type
Nominal tube voltage kv
Adjustment range of photography tube voltage
50~100
50~125
40~125
40~150
60～100
60~125
45~Nominal tube voltage
Can be set to 60kv
The adjustment range of tube voltage used for soft radiography shall not be less than 10~45kV. The tube voltage regulation system adopting arithmetic progression adjustment shall have a step difference of no more than 5kV. 4.1.3
Tube current
X-ray tube voltage adjustment range
50~100
45~100
45~100
The upper limit of the fluoroscopic tube current shall not exceed 5mA, and the ratio of the upper and lower limit setting values ​​of the tube current shall not be less than 10. The current of the photographic tube shall be adjusted in stages.
Dawn time and mAs
Both exposure time and mAs shall be adjusted in stages, and the priority number system R10 series shall be used for grading. Except for capacitive X-ray generators, the adjustment range of exposure time or mAs shall meet the requirements of Table 7. 4.1.4.2
Device nominal
output kw
10～20
75 ～100
Glow time s
Shortest value
mAs value
Glow time s
Longest value
mAs value
Specified value.
GB 4505--84
Capacitive X-ray generators shall use mAs as the control quantity, and its adjustment range shall be less than or equal to 1mAs to meet the requirements of Table 34.1.5. The energy conversion frequency value of non-sinusoidal X-ray generators shall comply with the specified series of relevant standards, and the allowable error and waveform distortion value shall be specified in the factory technical documents. 4.1.6 Automatic control system of photographic parameters
This system should indicate the dominant parameters of this system on its corresponding operating device, such as kV value or other corresponding clinically significant characterization values.
4.2 Errors of X-ray parameters
4.2.1 Except for capacitive X-ray generators, the X-ray parameter errors of various devices are as follows: a.
The allowable error of tube voltage shall not exceed 10%. The allowable error of tube current shall not exceed 10%, and the error of tube current of X-ray generators without filament heating transformers shall not exceed b.
±20%.
The allowable error of exposure time of different indicated values ​​shall be specified in Table 8. c.
Number of phases of X-ray generator
Single-phase or three-phase two-wire
Three-phase two-wire or three-phase
Working mode of time-limiting device
Phase switch
Non-phase switch
Phase switch
Exposure time T indicated value
<10 pulses
>10 pulses
Allowable error
±1 pulse
± 20%
±1 pulse
d. mAs allowable error: For X-ray generators using mAs value as exposure control quantity, the allowable error of mAs value is ±20%. However, when the corresponding exposure time is 0.1s, the allowable error of mAs value is ±10%. 4.2.2 When the permissible error of the tube voltage of the capacitive X-ray generator is ±5%, the wave tail cut-off voltage value of the photographic process shall not be less than 20kV, and the permissible error of mAs shall be ±20%.
4.3 Reliability of performance
4.3.1 Insulation resistance
The insulation resistance between the primary circuit of the power supply of the X-ray generator and the grounded metal part shall be greater than or equal to 2M2. 4.3.2 Withstand voltage of the primary circuit of the power supply
All types of devices can withstand a withstand voltage test of 50 Hz, sinusoidal wave, AC voltage of 1500 volts for 1 minute without breakdown or flashover (except low-voltage components).
4.3.3 Withstand voltage requirements of high-voltage circuits
Including non-sinusoidal X-ray generators, the withstand voltage of the high-voltage circuits of various types of devices shall meet the requirements of Table 9 according to their different structures and types.
Combined type
Transformer type
Capacitor type
4.4 Completeness
With X-ray tube
GB4505—84
Ratio of test voltage to
Nominal voltage
Without X-ray tube, long-term working system
Without X-ray tube head assembly
Without X-ray tube head assembly
Without X-ray tube head assembly
Duration
4.4.1 When the selection range of the photographic parameters of the X-ray generating device is likely to exceed the allowable photographic quota of the controlled X-ray tube, there should be a protection control device for the working parameters of the X-ray tube to achieve a one-time photographic condition limit. 4.4.2 Except for special X-ray generators, devices above 25kW can control no less than 2 X-ray tube heads, of which one tube head must have independently adjustable fluoroscopic working conditions. 4.4.3 For X-ray generators with more than 1 tube head, it is not necessary for all the X-ray tube heads controlled by it to meet the nominal capacity of the X-ray generator, but it should be able to control the capacity of each of the controlled X-ray tube heads. 4.4.4 For X-ray generators with more than 3 tube heads, the compensation device for the no-load power supply voltage fluctuation should be automatic. Within the allowable fluctuation range of the power supply voltage, it should ensure that the reference voltage of the device does not vary by more than ±3% of the nominal value. 4.4.5 For X-ray generators that control rotating anode X-ray tubes, it should ensure that exposure cannot be made when the rotation speed does not reach the rated value and that the starting process of the rotating anode does not exceed 1.5s.
4.4.6 When working under fluoroscopic conditions, X-ray generators with television systems should have a time limit device, and the maximum time limit of this device should not exceed 10 minutes. Before or at the end of the predetermined time limit, an audio or light signal shall be given. Test methods and inspection rules
5.1 Test methods
5.1.1 Except for special provisions, all tests shall be carried out under the following conditions. 5.1.1.1 Environmental conditions shall comply with the provisions of Article 3.1. 5.1.1.2 Power supply conditions:
8. The fluctuation range of the power supply voltage shall not exceed ±5% of the rated value; b. The non-sinusoidal distortion of the power supply voltage shall not exceed ±2% of its amplitude: the frequency change shall not exceed ±1% of the rated value. c.
* A combined X-ray generating device with a nominal tube voltage greater than or equal to 80% of the nominal tube voltage of photography shall be regarded as a long-term working system, otherwise, it shall be regarded as a short-term working system.
5.1.1.3 Length of high-voltage cable for test:
GB 4505-84
If there is no special provision in the technical documents of the tested device, it shall be 15±1m. 5.1.1.4 Thermal balance
When measuring the contents specified in Article 4.2, the X-ray generator shall be in a state of thermal balance. Unless otherwise specified, the high-voltage device under test shall be considered to be in a corresponding state of thermal balance after working for 0.5 hours at a load of 80% of the nominal output of the fluoroscopy. The nominal output of the fluoroscopy shall be specified in the technical documents of the device. 5.1.1.5 Measurement accuracy
The error of the measurement system shall not exceed 30% of the tolerance of the object under test. 5.2 Performance test
5.2.1 Determination of apparent internal resistance of power supply
5.2.1.1 The apparent internal resistance R of the power supply shall be calculated through the test according to the following formula: U. -U.
Where: R apparent internal resistance of power supply, Q,
U. Power supply voltage value when no load, V, U--power supply voltage value under test state, V1--power supply current when measuring the apparent internal resistance of the power supply, A. During the test, the test current value selected for the pure resistance load should be determined according to the nominal output of the X-ray generator under test, but it may not exceed 30kW. The error of the test system shall not exceed ±10%. 5.2.1.2 The apparent internal resistance of the power supply shall be adjusted after the test, and the error of the setting value shall not exceed 5%. For X-ray generators using three-phase power supply, the asymmetry of the apparent internal resistance of each phase power supply shall not exceed 10%. 5.2.2 Tube voltage measurement
The tube voltage of transformer X-ray generators and combined X-ray generators shall be carried out in accordance with the provisions of WS2/Z-一39-81 "Medical X-ray Machine Tube Voltage Test Method".
For capacitor X-ray generators, when measuring the tube voltage error, the voltage value of the wave tail cut-off shall be monitored at the same time. For non-sinusoidal X-ray generators, when measuring the tube voltage error, the voltage waveform and frequency shall be monitored at the same time. Its distortion and error shall meet the requirements of the technical documents of the device.
5.2.3 Tube current measurement
The X-ray generator shall be carried out in accordance with the provisions of WS2/Z一38一81 "Medical X-ray Machine Tube Current Test Method". This test can be carried out alone or simultaneously with the test in 5.2.2. 5.2.4 Exposure time measurement
The X-ray generator shall be carried out in accordance with the provisions of WS2/Z-4081 "Medical Diagnostic X-ray Machine Exposure Time Test Method". 5.2.5 mAs value determination
5.2.5.1 Select 5 points from the mAs value adjustment range. These 5 points should include: the minimum value, median value and maximum value of the mAs adjustment range. During the test, the load of the X-ray generator should be close to 70% of the allowable load under the mAs value. 5.2.5.2 The mAs table method can be used, or the values ​​of the tube current and exposure time can be measured at the same time, and then the product is calculated according to the definition of mAs. Two significant figures are taken when calculating.
5.2.6 Nominal value test
5.2.6.1 Fluoroscopic nominal value test: According to the fluoroscopic nominal output specified in the technical documents of the device, it is carried out at the fluoroscopic nominal tube voltage. The load time is 3 consecutive minutes, and observe whether there are any abnormal phenomena. 5.2.6.2 Photographic nominal value test: It is carried out at the nominal tube current of the device, and the maximum values ​​of the tube voltage and photography time allowed under this condition are observed to observe whether there are any abnormal phenomena. The above two tests should be carried out within the load range allowed by the X-ray tube. 5.2.7 Insulation resistance test
Make all switches of the primary circuit of the power supply of the X-ray generator in the closed circuit state, and measure with a megohmmeter of 500V or 1000V DC between the power supply terminal and the grounding terminal.
5.2.8 Withstand voltage test of the primary circuit of the power supply
GB4505-84
Under the conditions specified in 5.2.7, perform the test in accordance with the requirements of 4.3.2, and monitor the applied test voltage value at the same time. There should be no breakdown or flashover phenomenon.
5.2.9 Withstand voltage test of high-voltage circuit
Perform the test in accordance with the requirements of 4.3.3. For unstable power supply voltage, the test voltage must be guaranteed to be within the range of 100% to 105% of the rated test voltage value.
5.2.9.1 For transformer type and combined type X-ray generator, the test voltage starts from 50% of the specified test value during the test, and then the test voltage is increased to the specified test value within 10s. If there is a risk of overheating of the test component during the test, it is allowed to be carried out at a higher frequency. Slight corona is allowed during the test, but the corona should disappear when the test voltage drops below 110% of the nominal voltage. 5.2.9.2 For capacitor type X-ray generator, the test time should be calculated after the voltage of the energy storage capacitor is charged to the specified test voltage value.
5.2.10 The starting time test of the rotating anode X-ray tube shall be carried out according to the technical documents of the product. During the measurement process, the starting voltage value specified by the X-ray generator shall be monitored at the same time. 5.3 Inspection rules
5.3.1 The test items listed in this standard are all type tests or routine test items. When this device is shipped with other devices, its factory inspection and acceptance items shall comply with the provisions of the corresponding standards of the product. 5.3.2 When an X-ray generator is put into production as a new product, or when its structure, process or certain parts undergo major changes during the production process, type tests of relevant items shall be carried out. 5.3.3 X-ray generators that have been identified and put into production shall be subject to routine tests at regular intervals (-years in general) in accordance with the requirements of this standard. For products that are not put into production regularly, it shall be determined by their production cycle. 5.3.4 Before the test, an X-ray generator put into test is allowed to be adjusted once in accordance with the adjustment items and adjustment methods specified in the factory technical documents. After the adjustment is completed, the non-sinusoidal X-ray generator may carry out necessary charging of the energy storage element in accordance with the provisions of the factory technical documents. 6 Safety and Signs
6.1 Safety
6.1.1 Connection of High-voltage Cables
6.1.1.1 There should be clear “+” and “-” signs near the sockets of high-voltage cables. For X-ray generators with more than or equal to 2 heads, there should also be clear head grouping marks on the high-voltage generator or the high-voltage switch box. 6.1.1.2 There should be warning signs near the sockets of high-voltage cables of capacitive X-ray generators, indicating under what conditions it is allowed to unplug or plug in the high-voltage cables.
The plugging and unplugging of cables must be carried out with tools, or an interlocking discharge device should be used. 6.1.1.3 For high-voltage generators with more than 1 X-ray heads, the sockets of each head should be independently controlled by the corresponding high-voltage switch. 6.1.2 Connection between the controller and the high-voltage generator or the combined X-ray head. 6.1.2.1 Certain measures must be taken to ensure that when the insulation of the high-voltage circuit fails, high voltage will not appear in the low-voltage circuit of the X-ray generator. 6.1.2.2 On the measurement terminals of the controller or other tube current, the danger of an open circuit in the measurement circuit should be considered. Where high voltage may occur, voltage protection elements should be installed.
6.1.3 Protection against electric shock
6.1.3.1 The energy storage capacitor assembly of the non-sinusoidal X-ray generator should be equipped with an interlock discharge device to ensure that the maintainer must discharge or short-circuit before approaching the capacitor bank.
6.1.4 Grounding
6.1.4.1 The metal part of any component that may come into contact with the human body should be reliably grounded. The marking and color of the grounding wire used should comply with the provisions of WS2-295-83 "General Safety Requirements for Medical Electrical Equipment". 6.1.4.2 Each component should be equipped with a special grounding terminal to achieve connection between components or between components and "ground". 130
GB4505—84
6.1.4.3 Movable X-ray generators should have additional grounding wires. 6.1.4.4 It is not allowed to replace the ground with the neutral line of the power supply. 6.1.5 Operation
6.1.5.1 The closing or opening of the contacts of each phase of the power switch of the power supply should be realized simultaneously with each other. 6.1.5.2 All switching elements such as relays, contactors, limit switches, etc. should be immediately operated or returned to their positions after the action signal (such as excitation voltage, operating pressure, etc.) appears or is released, except for the elements with slow-action function specified by the design. 6.1.6 Radiation protection
6.1.6.1 In addition to the X-ray tube head assembly, if there are other additional radiation sources, necessary shielding should be carried out and radioactive marks should be given on the shielding. 6.1.6.2 The protection performance of the X-ray tube head assembly should meet the requirements of WS2—300-78 "Regulations on Hygiene Protection of Medical Diagnostic X-rays". 6.2 Marking
6.2.1 The operation and control panel shall indicate the function, status and range of each operating element in accordance with the provisions of WS2258-79 "Image Marking of Medical Diagnostic X-ray Equipment".
6.2.2 For X-ray generators that may work in darkroom conditions, the instruments used must have light or illumination devices. 6.2.3 Tube current, tube voltage and time control quantity must be marked and indicated in kV, mA and s or mAs respectively. The marking must be able to distinguish the two load states of working under photographic conditions or fluoroscopic conditions. 6.2.4 The operation process of radiation can provide the operator with necessary information by light or sound. If it is a light display, it should be marked as follows: Red: Only used when it is necessary to cut off the power immediately or the irradiation conditions are overloaded and the X-ray radiation is in a dangerous state. a.
Green: Indicates that the X-ray generator has entered the irradiation preparation state. Yellow: Indicates that the X-ray radiation process is in progress. Nameplate regulations
The nameplate of the controller shall include at least the following signs: manufacturer's name;
product name and model,
power supply voltage,
maximum instantaneous current at nominal output load or maximum power supply current value of X-ray generator at the initial charging stage: factory number and date,
this standard number.
The nameplate of the high-voltage generator shall include at least the following signs: a.
manufacturer's name,
product name and model,
rectification method and ratio of primary voltage to secondary voltage; nominal output of fluoroscopy and nominal output of photography, factory number and date.
7 Factory technical documents
The manufacturer shall provide the user with technical documents that meet the requirements of this standard in a complete set or in a component form according to the factory conditions of the device.
7.1 Technical documents shall comply with the following marks:
Certificate of conformity issued by the technical inspection department of the manufacturer; a.
b. Installation and operating instructions, circuit diagrams, factory catalogs of vulnerable and consumable parts or spare parts suitable for the device or component provided. For the content supplied by a third party, its model, name and specifications shall be given in accordance with the relevant standards:
d. Packing list and necessary unsealing and counting methods; e.
Inspection certificate of safety and protection regulations that must be met as stipulated in other standards or proof of the period of verification; 131
GB4505-84
f. Quality assurance conditions and quality assurance statement of the manufacturer for the device or component provided. 7.2 Completeness of factory technical documents
7.2.1 The quantity values ​​and units of all documents must comply with the provisions of relevant standards. 7.2.2 The terms or codes used shall comply with the provisions of relevant professional standards. 7.2.3 The following contents must be clearly stated in the document: a. Requirements for power supply (or battery pack) and technical measures when changing power supply (or battery pack); b. Transformer ratio and normal no-load value and full-load value related to the working state of the X-ray tube; c. Insulating oil grade,
Adjustment and test methods that determine the working state of the X-ray tube and the state given by the manufacturer when leaving the factory. For non-sinusoidal X-ray generators, the adjustment test method of the energy conversion system should be given, relevant technical data of key components
The weight and dimensions of the device or component; description of necessary safety measures.
Additional notes:
This standard was proposed by the National Technical Committee for Standardization of Medical Electrical Appliances and is under the jurisdiction of the Shanghai Institute of Medical Instruments. This standard was drafted by the Beijing Medical Radiation Machine Factory. The main drafter of this standard is Lv He.
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