YY/T 0106-2021 English PDF (YY/T0106-2021)

YY/T 0106-2021: General specifications for medical diagnostic X-ray equipment
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YY/T 0106-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.50
C 43
Replacing YY/T 0106-2008
General Specifications for Medical Diagnostic X-ray
Equipment
ISSUED ON. SEPTEMBER 6, 2021
IMPLEMENTED ON. SEPTEMBER 1, 2022
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 6
4 Classification and Composition... 6
5 Requirements... 6
6 Test Methods... 14
General Specifications for Medical Diagnostic X-ray
Equipment
1 Scope
This document specifies the classification and composition, requirements and test methods of
medical diagnostic X-ray equipment.
This standard applies to medical diagnostic X-ray equipment. For medical diagnostic X-ray
equipment that are required by national or industry-specific standards, the corresponding
national or industry-specific standards shall also be implemented.
This standard does not apply to X-ray computerized tomography equipment.
2 Normative References
The following documents are indispensable to the application of this document. In terms of
references with a specified date, only versions with a specified date are applicable to this
document. In terms of references without a specified date, the latest version (including all the
modifications) is applicable to this document.
GB 9706.1 Medical Electrical Equipment - Part 1.General Requirements for Safety
GB 9706.3 Medical Electrical Equipment - Part 2.Particular Requirements for the Safety of
High-voltage Generators of Diagnostic X-ray Generators
GB 9706.11 Medical Electrical Equipment - Part 2.Particular Requirements for the Safety of
X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis
GB 9706.12 Medical Electrical Equipment - Part 1.General Requirements for Safety 3.
Collateral Standard. General Requirements for Radiation Protection in Diagnostic X-ray
Equipment
GB 9706.14 Medical Electrical Equipment - Part 2.Particular Requirements for the Safety of
Associated Equipment of X-ray Equipment
GB 9706.23 Medical Electrical Equipment - Part 2-43.Particular Requirements for the Safety
of X-ray Equipment for Interventional Procedures
GB 9706.24 Medical Electrical Equipment - Part 2-45.Particular Requirements for the Safety
of Mammographic X-ray Equipment and Mammographic Stereotactic Devices
GB/T 10149 Terminology and Symbol for Medical X-ray Equipment
GB/T 19042.1 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1.
Acceptance Test - Imaging Performance of X-ray Equipment for Radiographic and Radioscopic
Systems
GB/T 19042.3 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-3.
Acceptance Tests - Imaging Performance of X-ray Equipment for Digital Subtraction
Angiography (DSA)
YY/T 0202 Specifications for Medical Diagnostic X-ray Device for Tomography
YY/T 0291 Enviromental Requirements and Test Methods for Medical X-ray Equipment
YY 0505 Medical Electrical Equipment - Part 1-2.General Requirements for Safety - Collaterla
Standard. Electromagnetic Compatibility - Requirements and Tests
YY/T 0910.1 Medical Electrical Equipment - Medical Image Display Systems - Part 1.
Evaluation Methods
YY/T 1708 (all parts) Basic Requirements of Communication and Conformance for Medical
X-ray Image Equipment
3 Terms and Definitions
The terms and definitions defined in GB/T 10149, GB/T 19042.1, GB/T 19042.3 and YY/T
0910.1 are applicable to this document.
4 Classification and Composition
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 Requirements
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.
 Continuously displayed in mGy at the operator’s work position and updated
at least every 5 seconds, or
 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 ...