YY/T 0106-2021General specifications for medical diagnostic X-ray equipment (English PDF)

4.1 Classification

The product can be classified in accordance with its intended use and / or its structure.

4.2 Composition

Medical diagnostic X-ray equipment shall at least consist of high voltage generators, X-ray source assemblies (which may include an X-ray tube assembly and a beam limiter) and mechanical support devices.

Medical diagnostic X-ray equipment may also include the following components. high-voltage connectors, accessory equipment and imaging devices of X-ray equipment, etc.

5.1 Working Conditions

5.1.1 Environmental conditions

Unless otherwise specified, the environmental conditions for the operation of the medical diagnostic X-ray equipment shall satisfy the following requirements.

a) Ambient temperature. 10 °C ~ 40 °C;

b) Relative humidity. 30% ~ 75%;

c) Atmospheric pressure. 700 hPa ~ 1,060 hPa.

5.1.2 Power supply conditions

The power supply conditions for the operation of the medical diagnostic X-ray equipment shall satisfy the following requirements.

a) Power supply voltage and number of phases. specified by the manufacturer, the grid voltage fluctuation shall not exceed ±10% of the nominal value;

b) Power supply frequency. 50 Hz ± 1 Hz;

c) Power supply resistance. specified by the manufacturer;

d) Power supply capacity. specified by the manufacturer.

5.2 Electric Power

5.2.1 Maximum output electric power

For medical diagnostic X-ray equipment operating in continuous mode and / or in intermittent mode, the corresponding combinations of X-ray tube voltage and X-ray tube current that result in the maximum output electric power shall be specified.

5.2.2 Nominal electric power

The maximum constant electric power output in the unit of kW that a medical diagnostic X-ray equipment can provide when the loading time is 0.1 s and the X-ray tube voltage is 100 kV (30 kV for mammographic X-ray equipment) shall be specified as the given nominal electric power.

If this value cannot be pre-selected, the X-ray tube voltage value that is closest to 100 kV (30 kV for mammographic X-ray equipment) and the closest loading time value can be used, but it must not be shorter than 0.1 s.

The nominal electric power shall be given together with the combination of X-ray tube voltage, X-ray tube current and the loading time.

5.3 Loading Factors and Control

5.3.1 X-ray tube voltage

The X-ray tube voltage shall meet the following requirements. fluoroscopy frame rate shall not be greater than 2 s;

c) The repeatability of the automatic radiation control of the digital mammographic equipment shall be measured by the deviation of the dose or milliampere-second, and the deviation value shall not be greater than ±5%.

5.4 Imaging Performance

5.4.1 Indirect radiography and indirect radio-fluoroscopic imaging performance The performance of indirect radiography and indirect radio-fluoroscopic imaging shall comply with the requirements of national or industry-specific standards. If there is no applicable national or industry-specific standard, the manufacturer shall specify the indirect radiography and indirect radio-fluoroscopic imaging performance, and under specified conditions, at least the following requirements shall be specified.

a) Spatial resolution;

b) Low contrast resolution;

c) Image uniformity;

d) Effective imaging area size; e) Artifacts.

NOTE. for the mammographic X-ray equipment, no requirement is imposed on the size of the effective imaging area.

5.4.2 Digital subtraction angiography (DSA) imaging performance

The manufacturer shall specify at least the following requirements.

a) Dynamic range;

b) DSA contrast sensitivity;

c) Requirements regarding artifacts.

5.4.3 Three-dimensional imaging performance

If there is a three-dimensional imaging function, the manufacturer shall provide the spatial resolution of the three-dimensional imaging mode.

5.4.4 Quantum detection efficiency

If applicable, the manufacturer shall provide in the accompanying documents the values of the quantum detection efficiency of the detector used for the specified standard radiation quality, radiation dose and different spatial frequencies.

5.5 Radiation Safety

5.5.1 Dose instructions

If dose instructions are included, they shall meet the following requirements.

a) The accompanying documents shall provide information on the performance of the dosimetry indications and describe the operational requirements for maintaining performance within the specified range.

b) A method shall be provided to reset all cumulative dosimetry indications to zero before starting a new examination or procedure.

c) Medical diagnostic X-ray equipment used for radio-fluoroscopy or with radio- fluoroscopy and sequential radiography functions shall satisfy the following requirements.

---The average air kerma rate value during radio-fluoroscopy and sequential radiography shall be displayed in the unit of mGy/min. During the radiation switch operation, this value shall be continuously displayed at the operator's working position and updated at least once every second.

---After the last reset operation, the cumulative reference air kerma values generated by radio-fluoroscopy and pulse radiography shall be.

lambda Continuously displayed in mGy at the operator's work position and updated at least every 5 seconds, or lambda Displayed within 5 seconds after interruption or termination of loading.

---The reference air kerma rate and the cumulative reference air kerma shall be clearly distinguishable.

---The manufacturer shall specify the air kerma rate and the cumulative air kerma and their deviations.

d) An indication of the cumulative dose-area product resulting from radiography and radio-fluoroscopy since the last reset operation shall be provided. The dose-area product can be obtained by measurement or calculation. The manufacturer shall specify the deviation of the cumulative dose-area product.

e) X-ray equipment used for indirect radiography contains a dose-area product indication for the radiography mode. The manufacturer shall specify the deviation of the dose-area product after a single exposure.

NOTE. the above-mentioned air kerma, air kerma rate and dose-area product may be displayed using SI prefixes. can be used without an anti-scatter grid.

d) If the anti-scatter grid is removable by the operator or moved in or out by manual or automatic control through an electric device, the presence or absence of the anti- scatter grid shall be clearly visible or clearly indicated. If the anti-scatter grid is removable, then, its removal or replacement shall not require the use of tools.

e) Measures shall be provided to enable the installation of an additional filter plate with a diameter not less than 0.1 mmCu or 3.5 mmAl.

NOTE. for e), a suitable permanently installed filter plate which cannot be removed by the operator satisfies the above-mentioned requirements.

5.7 Mechanical Device Performance

5.7.1 Mechanical motion range

The manufacturer shall specify the rotation angle range and longitudinal, lateral and vertical movement range of the equipment and their deviation values.

5.7.2 Length indication value

The deviation of the indicated length from the actual value is specified by the manufacturer.

5.7.3 Angle indication value

The deviation of the indicated angle from the actual value is specified by the manufacturer.

5.7.4 Braking force

The mechanical device shall have a braking device (except for the random balancing part of the suspension device that does not require braking), and its braking force for linear motion shall be no less than 100 N.

5.7.5 Starting force

Under continuous X-ray radiation conditions, the starting force of moving parts that require manual operation shall not exceed 50 N.

5.7.6 Load-bearing

Devices supporting adult patients shall normally function after being subjected to the maximum load specified by the manufacturer.

5.7.7 Noise

The noise generated by a medical diagnostic X-ray equipment when operating in a no-load state (non-load-bearing state) shall not exceed 70 dB (A-weighted network) (excluding non- continuous and non-periodic noise within 3 s).

NOTE. consider possible composite noise generated by composite motion.

5.8 Network and Software

5.8.1 Communication and conformance

It shall comply with the requirements of YY/T 1708.

5.8.2 System Software

If applicable, the manufacturer shall specify the functions of the system software.

5.9 X-ray Tomography

If applicable, it shall comply with the requirements of YY/T 0202.

5.10 Accompanying Documents

The accompanying documents shall contain instructions for the quality control procedures recommended by the manufacturer and the tests performed by the responsible party on the X- ray equipment, which shall include the acceptance criteria and test frequency for each test.

NOTE. the intention is to use only the information provided for the implementation of quality control procedures and tests.

In addition, for X-ray equipment provided with an integrated digital X-ray image receptor, the accompanying documents shall contain.

---Identification of adjustable or optional image processing used for the original data, including version No. or how to determine its identification;

---A description of the image file transfer format, including the image acquired by the unit and all data related to the image.

In accordance with the intended use, the performance requirements of display equipment for obtaining images for diagnostic purposes shall be stated.

If a test or quality control procedure requires a specific test tool that is only available from the manufacturer, then, the manufacturer shall make the tool or its specifications available to the responsible party.

When any mammographic stereotactic device is designed as an accessory to mammographic X-ray radiographic equipment, the accompanying documents shall contain.

---The model or type reference No. of at least one mammographic X-ray radiographic equipment with which it is to be operated;

---Instructions on compliance of the mammographic stereotactic device with relevant standards.

6.2 Electric Power

6.2.1 Maximum output electric power

Load in accordance with the combination of loading factors that results in the maximum output electric power of the system and observe whether there are any abnormal phenomena.

6.2.2 Nominal electric power

Load in accordance with the combination of X-ray tube voltage, X-ray tube current and loading time that results in the nominal electric power of the system and observe whether there are any abnormal phenomena.

6.3 Loading Factors and Control

6.3.1 X-ray tube voltage

Proceed in accordance with the following methods.

a) Perform actual operations to verify compliance with the requirements of 5.3.1a);

b) For mammographic X-ray equipment, measurement shall be performed at an X-ray tube voltage of 30 kV or, if clinically proven, the manufacturer's specified X-ray tube voltage, together with the optional minimum and maximum X-ray tube voltages, and at the lowest, intermediate and highest optional values of the current-time product.

For each combination of X-ray tube voltage and current-time product, perform 10 measurements, preferably within 1 h. For other medical diagnostic X-ray equipment.

1) In the radiographic mode.

The measurements shall be performed with the X-ray tube voltage at its lowest indicated value and at the highest X-ray tube current obtainable at that X-ray tube voltage and with the loading time at its shortest indicated value.

The measurements shall be performed at the lowest indicated value of the X-ray tube voltage and at the highest X-ray tube current obtainable at that X-ray tube voltage and a loading time of approximately 0.1 s.

The measurements shall be performed at the highest indicated value of the X-ray tube voltage and at the highest X-ray tube current obtainable at that X-ray tube voltage and a loading time of approximately 0.1 s.

2) In the radio-fluoroscopic mode.

The tests shall be carried out at 90% of the maximum obtainable X-ray tube voltage and at any one X-ray tube current condition.

The tests shall be carried out at 60% of the maximum obtainable X-ray tube voltage and at any one X-ray tube current condition.

6.3.2 X-ray tube current

Proceed in accordance with the following methods.

a) Perform actual operations to verify compliance with the requirements of 5.3.2a);

b) For mammographic X-ray equipment, perform a measurement under the conditions with the X-ray tube current at the lowest indicated value, the X-ray tube voltage at the highest indicated value and the loading time at the shortest indicated value.

Perform a measurement under the conditions with the X-ray tube current at the lowest indicated value, the X-ray tube voltage at the highest indicated value and the loading time of approximately 1 s.

Perform a measurement under the conditions with the X-ray tube current at the highest indicated value, the X-ray tube voltage at the highest value obtainable at that X-ray tube current and the loading time of approximately 1 s. For other medical diagnostic X-ray equipment.

1) In the radiographic mode.

The measurements shall be carried out under the conditions with the X-ray tube current at the lowest indicated value, the X-ray tube voltage at the highest indicated value and the loading time at the shortest indicated value.

The measurements shall be carried out under the conditions with the X-ray tube current at the lowest indicated value, the X-ray tube voltage at the highest indicated value and the loading time of approximately 0.1 s.

The measurements shall be carried out under the conditions with the X-ray tube current at the highest indicated value, the highest X-ray tube voltage value obtainable at that X-ray tube current and the loading time of approximately 0.1 s.

2) In the radio-fluoroscopic mode.

The measurements shall be performed at 20 % of the maximum obtainable X- ray tube current and at the lowest obtainable X-ray tube voltage.

The measurements shall be performed at 20 % of the maximum obtainable X- ray tube current and at the highest obtainable X-ray tube voltage.

6.3.3 Loading time

the X-ray tube voltage to 80 kV; perform 10 AEC exposures and calculate the coefficient of variation of the air kerma measurement values.

b) The stabilization time of the radio-fluoroscopic image in the ABS mode is carried out in accordance with the following methods.

Place a 20 mm aluminum plate in the X-ray field, perform automatic radio- fluoroscopy continuously or at the highest frame rate, and record the time interval from the first radio-fluoroscopic image displayed on the screen to the stable radio- fluoroscopic image, which shall comply with the requirements of 5.3.6.If the general timer cannot measure the radio-fluoroscopic image stabilization time, the manufacturer shall provide a test method.

c) For mammographic X-ray equipment, place a 40 mm thick polymethyl methacrylate (PMMA) phantom on the patient support, with the edge of the phantom aligned with the chest wall side of the patient support; press the compression plate on the phantom; set the tube voltage and target / filter commonly used in clinical practice, and perform AEC exposure; repeat the exposure 5 times and calculate the maximum deviation of the current-time product or dose value measured each time from the corresponding average value.

NOTE. automatic exposure control is provided to function in all possible combinations, e.g., with grid, without grid, magnified radiography, non-magnified radiography and various target / filter combinations; in addition, the probe for measuring dose shall avoid affecting the AEC sensor.

6.4 Imaging Performance

6.4.1 Indirect radiography and indirect radio-fluoroscopic imaging performance Conduct tests in accordance with the methods required by national or industry-specific standards.

If there are no applicable national or industry-specific standards, the test should be carried out in accordance with the corresponding provisions in GB/T 19042.1, or in accordance with the methods specified by the manufacturer.

6.4.2 Digital subtraction angiography (DSA) imaging performance

Conduct the test in accordance with the methods required by national or industry-specific standards.

If there are no applicable national or industry-specific standards, the test should be carried out in accordance with the corresponding provisions in GB/T 19042.3, or in accordance with the methods specified by the manufacturer.