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YY/T 0106-2021 PDF English (YY/T 0106-2008: Older version)Search result: YY/T 0106-2021 (YY/T 0106-2008 Older version)
YY/T0106-2021 (YYT0106-2021): PDF in EnglishYY/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 .......Source: https://www.ChineseStandard.net/PDF.aspx/YYT0106-2021 |