YY/T 0741-2018 English PDF (YY/T 0741-2009)

YY/T 0741-2018_English: PDF (YY/T0741-2018)
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 0741-2018150 Add to Cart Auto, < 3 mins Particular specifications for digital X-ray radiography system Valid
YY/T 0741-200985 Add to Cart Auto, < 3 mins General specification for digital medical X-ray radiography system Obsolete

BASIC DATA
Standard ID YY/T 0741-2018 (YY/T0741-2018)
Description (Translated English) Particular specifications for digital X-ray radiography system
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 18,160
Date of Issue 2018-09-28
Date of Implementation 2019-10-01
Older Standard (superseded by this standard) YY/T 0741-2009
Quoted Standard GB 9706.1; GB 9706.3-2000; GB 9706.11; GB 9706.12-1997; GB 9706.14; GB 9706.15; GB/T 10151; YY/T 0291; YY 0505; DICOM 3.0
Drafting Organization Liaoning Medical Device Inspection and Testing Institute, Shanghai Siemens Medical Devices Co., Ltd., Shanghai Lianying Medical Technology Co., Ltd., Derunte Medical Technology (Wuhan) Co., Ltd.
Administrative Organization National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliance Subcommittee (SAC/TC 10/SC 1)
Regulation (derived from) State Drug Administration Announcement No. 72 of 2018
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the terms and definitions, system components, requirements and test methods of digital photographic X-ray machines (hereinafter referred to as DR systems). This standard applies to DR systems for general X-ray photography. Including but not limited to DR systems using line scan or area array scanning detectors, such as: 1. DR system using flat panel detector (FPD); 2. DR system using area array CCD detector; 3. Using line array Scan the DR system of the CCD detector; 4. Use the DR system of the CMOS detector. Corresponding to the DR system using more than one digital X-ray image detector, this standard applies to each digital X-ray image detector and its X-ray generating device used in imaging. This standard does not apply to systems using X-ray image intensifiers.

BASIC DATA
Standard ID YY/T 0741-2009 (YY/T0741-2009)
Description (Translated English) General specification for digital medical X-ray radiography system
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 19,162
Date of Issue 2009-11-15
Date of Implementation 2010-12-01
Quoted Standard GB 9706.1-2007; GB 9706.3-2000; GB 9706.11-1997; GB 9706.12-1997; GB 9706.14-1997; GB 9706.15-2008; GB/T 10149; GB/T 10151-2008; GB/T 17857-1999; GB/T 19042.1-2003; YY/T 0106-2008; YY/T 0291-2007; YY 0505-2005; DICOM 3.0
Drafting Organization Space Star Space Applications Limited
Administrative Organization National Standardization Technical Committee of Medical electrical equipment
Regulation (derived from) State Food and Drug Administration Notice 2011 No. 45; industry standard filing Notice 2010 No. 2 (No. 122 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies: digital medical X -ray imaging system (hereinafter referred to as DR systems) terms and definitions, system configuration, requirements and test methods. This standard applies to general X -ray photography DR systems. Including but not limited to using line scan or area scan detector DR systems, example: the use of flat panel detector (FPD) DR systems, using CCD array detector DR systems, using line scan CCD detector DR systems, using CMOS detector DR systems. For more than using a digital X- ray image detector DR systems, This standard applies to every digital image detectors and X -ray imaging used X -ray generator. This standard does not apply to the use of X -ray image intensifier System, a computerized X -ray imaging systems, breast X -ray equipment, dental X -ray equipment, computed tomography equipment and dual-energy imaging equipment DR systems.


YY/T 0741-2018 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.50 C 43 Replacing YY/T 0741-2009 Particular Specifications for Digital X-Ray Radiography System ISSUED ON: SEPTEMBER 28, 2018 IMPLEMENTED ON: OCTOBER 01, 2019 Issued by: National Medical Products Administration Table of Contents Foreword ... 3 1 Scope ... 5 2 Normative References ... 5 3 Terms and Definitions ... 6 4 System Composition ... 8 5 Requirements ... 8 6 Test Methods ... 15 Appendix A (Normative) Test Arrangement ... 23 Appendix B (Informative) Test Phantom ... 24 Appendix C (Informative) Drafting Explanation of Some Clauses ... 27 Particular Specifications for Digital X-Ray Radiography System 1 Scope This Standard specifies the terms and definitions, system composition, requirements and test methods for digital X-ray radiography system (hereinafter referred to as DR system). This Standard is applicable to the DR system for general X-ray photography. It includes but not limited to DR systems that use line scan or area scan detectors, such as: --- DR system using flat panel detector (FPD); --- DR system using area array CCD detector; --- DR system using line array scanning CCD detector; --- DR system using CMOS detector, etc. Corresponding to the DR system using more than one digital X-ray image detector, this Standard is applicable to each digital X-ray image detector and the X-ray generating device used in its imaging. This Standard is not applicable to system using X-ray image intensifier, system using imaging device of image plate for X-ray photography, mammary X-ray equipment, dental X-ray equipment, computed tomography equipment, mobile DR system. 2 Normative References The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document. GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety GB 9706.3-2000 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 9706.12-1997 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 9706.15 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral Standard: Safety Requirements for Medical Electrical Systems GB/T 10151 Medical Diagnostic X-Ray Equipment - Specifications for High Voltage Cable Plugs and Sockets YY/T 0291 Environmental Requirements and Test Methods for Medical X-Ray Equipment YY 0505 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility Requirements and Tests DICOM 3.0 (all parts) Digital Imaging and Communications in Medicine (Edition III) 3 Terms and Definitions For the purposes of this document, the terms and definitions given in Normative References and the following apply. 3.1 Digital radiography system It uses digital X-ray image detector technology to realize the X-ray photography; generally, it consists of X-ray generating device, digital X-ray imaging device, and ancillary equipment. 3.2 Digital X-ray imaging device The system that uses digital X-ray image detector; consists of the subsystem that can be able to perform the image processing, displaying, printing or storing; provides the projecting images in a digital format. 3.3 Digital X-ray image detector The converter, after spatial sampling of X-ray by a line array or matrix pixel structure, shall be less than 3mm; c) In the image stitching function, the manual adjustment function shall be provided; d) On the image after stitching, the stitching position shall be marked. 5.4.9 Detector calibration and stability test a) The DR system shall have the function of supporting the user to perform conventional detector calibration; b) The manufacturer shall provide the content and frequency of the stability test in accompanying file; the DR system shall provide a stability test procedure. 5.4.10 Quantum detection efficiency The manufacture shall give, in the accompanying file, the quantum detection efficiency value of the used detector at the indicated standard radiation quality, irradiation dose and different spatial frequencies (at least 0.5lp/mm, 1.0lp/mm, 1.5lp/mm, 2.0lp/mm, 2.5lp/mm up to slightly lower than the maximum frequency of NYQUIST sampling frequency). 5.5 Performance of mechanical device 5.5.1 Mechanical motion range It shall be specified in the product technical requirements for the rotation angle range of electromechanical auxiliary device, and motion range in the longitudinal, transverse and vertical directions, and their deviations. 5.5.2 Length indication value The deviation between the length indication value and the actual value shall be within the range of ±5% indication value. 5.5.3 Angle indication value The deviation between the angle indication value and the actual value shall be within the range of ±1 minimum division value. 5.5.4 Braking The linear motion part of the mechanical device shall have a braking device. After the network power is turned off or the emergency stop switch is pressed, the motion parts shall be braked. (Except that the suspension is required to be balanced without the need for braking) the braking force shall be no less than 100N. The braking force of the rotating parts shall be specified by the product technical requirements. 5.10 Safety It shall meet the requirements of GB 9706.1, GB 9706.3, GB 9706.11, GB 9706.12, GB 9706.14, GB 9706.15 and YY 0505. 6 Test Methods 6.1 Test conditions 6.1.1 Environmental conditions It shall conform to the provisions of 5.1.1. 6.1.2 Power supply conditions The test power supply conditions are as follows: a) The network voltage and the number of phases shall conform to the provisions of product technical requirements; the network voltage fluctuation shall not exceed ±10% nominal value; b) Power supply frequency: 50Hz±1Hz; c) The power supply resistance shall conform to the provisions of 5.1.2 c); d) The power supply capacity shall conform to the provisions of 5.1.2 d). 6.2 Electric power 6.2.1 Maximum output electric power The DR system operating in an intermittent mode is loaded in the combination with the loading factors that cause the maximum output electric power; then observe whether there is an abnormality. 6.2.2 Nominal electric power The DR system operating in an intermittent mode is loaded in the combination with X- ray tube voltage, X-ray tube current, loading time that cause the nominal electric power; then observe whether there is an abnormality. 6.3 Loading factor and control 6.3.1 X-ray tube voltage It shall be performed as per the following methods: Under the AEC mode, the repeatability of radiation output shall be performed as follows: Set the DR system to the normal use mode specified by the manufacturer; using PMMA phantoms, the thickness of which is suitable for intended use; in the case the manufacturer does not make statement, use 20cm-thick PMMA phantom; place the dosimeter probe on the surface of PMMA phantom; set the X-ray tube voltage to be 80kV; perform 10 times AEC exposures; calculate the coefficient of variation for air kerma measurement value. 6.3.7 Correspondence between X-ray field and image receiving surface It shall be performed as per the following methods: a) The measurement shall, under the various normal use modes of the equipment, be performed separately at the minimum and maximum SID situations of the clinical application specified in the accompanying file; b) For the equipment that provides automatic adjustment of radiation window, allow 5s adjustment time before measurement; c) It shall conform to the provisions of 29.203.4 in GB 9706.12-1997. 6.3.8 Dose area product indication It shall be performed as per the following methods: Place the X-ray dosimeter detector in an appropriate position in the X-ray beam, such as on the image receiver surface or bed surface. Adjust the X-ray filed dimension to 15cm×15cm or other proper dimensions. Take photograph to dose area product that is displayed by the equipment is greater than 5µGy•m2; multiply the measured dose value by the ray filed area at the air kerma dosimeter detector. It can also be measured directly by the dose area product meter. Calculate the error between displayed value and the measured value. 6.3.9 Pediatric photography requirements Actual operation and inspection. 6.4 Imaging performance 6.4.1 Spatial resolution Test and arrange the multi-function test card shown in Figure B.1 according to Figure A.1. Adjust SID to be the normal clinical use distance; set the visual field of the image to be the maximum effect image area of the plate; select the typically clinical protocol specified by the manufacturer; manually set the X-ray tube voltage to be 75kV±7kV; AEC automatic exposure. If required, adjust the window width and position; record the Vi – average of gray scale of each sampling area; Vm – average of gray scale of 9 sampling areas; R – standard deviation of gray scale of 9 sampling areas. 6.4.5 Effect image area The test procedures are as follows: a) Remove the grid; b) Place the lead scale at a position close to the image receiving surface; paralleling to the m......


YY/T 0741-2009 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.50 C 43 General Specifications for Digital Medical X-Ray Radiography System ISSUED ON. NOVEMBER 15, 2009 IMPLEMENTED ON. DECEMBER 1, 2010 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative References ... 4  3 Terms and Definitions ... 5  4 System Structure ... 7  5 Requirements ... 7  6 Test Methods ... 13  Appendix A ... 21  Appendix B ... 22  Appendix C ... 23  Appendix D ... 24  Foreword This Standard’s Appendix A is normative; while Appendix B, C, and D are informative. This Standard shall be under the jurisdiction of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China, Medical X-Ray Equipment and Appliance at the Standardization Technical Subcommittee (SAC/TC 10/SC 1). Drafting organizations of this Standard. Space Star Aerospace Technology Applications Co., Ltd., Liaoning Medical Device Testing Institute, Siemens Shanghai Medical Equipment Ltd., Shenyang Normal University, Beijing Wandong Medical Equipment Co., Ltd., Shenzhen Angell Technology Co., Ltd., and General Hospital of the People's Liberation Army. Chief drafting staffs of this Standard. Zou Yuan, Xia Lianji, Liu Congzhi, Tan Dagang, Lu Jinming, Ge Yilin, and Du Luoshan. General Specifications for Digital Medical X-Ray Radiography System 1 Scope This Standard specifies the terms and conditions, system compositions, requirements and test methods of digital medical X-ray radiography system (hereinafter refers to DR system). This Standard is applicable to the general X-ray radiography DR system. Including but not limited to DR system that adopts line scanning and area scanning detectors, for instance. -- DR system that adopts Flat Panel Detector (FPD); -- DR system that adopts Area CCD Detector; -- DR system that adopts Line Scanning CCD Detector; -- DR system that adopts CMOS Detector. As for the DR system that adopts the above digital X-ray image detector, this Standard is applicable to each digital X-ray image detector, and X-ray generator for imaging. This Standard is not applicable to the DR systems that adopt X-ray image intensifier system, computer X-ray radiography system, breast X-ray equipment, dental X-ray equipment, computer tomography equipment, and dual energy image equipment. 2 Normative References The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Standard; however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 9706.1-2007 Medical Electrical Equipment – Part 1. General Requirements for Basic Safety (IEC 60601-1.1988, IDT) GB 9706.3-2000 Medical Electrical Equipment - Part 2. Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators (idt IEC 60601-2-7.1988) GB 9706.11-1997 Medical Electrical Equipment - Part 2. Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis (idt IEC 60601-2-28.1983) GB 9706.12-1997 Medical Electrical Equipment - Part 1. General Requirements for Safety 3 Collateral Standard. General Requirements for Radiation Protection In Diagnostic X- ray Equipment (idt IEC 60601-1-3.1984) GB 9706.14-1997 Medical Electrical Equipment - Part 2. Particular Requirements for the Safety of Associated Equipment of X-ray Equipment (idt IEC 60601-2-32.1984) GB 9706.15-2008 Medical Electrical Equipment - Part 1-1. General Requirements for Safety - 1 Collateral Standard. Safety Requirements for Medical Electrical System (IEC 60601-1-1.2000, IDT) GB/T 10149 Terminology and Symbol for Medical X-ray Equipment GB/T 10151-2008 Medical Diagnostic X-ray Equipment - Specifications for High Voltage Cable Plugs and Sockets GB/T 17857-1999 Medical Radiology – Terminology (Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry) GB/T 19042.1-2003 Evaluation and Routine Testing in Medical Imaging Departments-Part 3-1. Acceptance Test - Imaging Performance of X-ray Equipment for Radiographic and Radioscopic Systems (IEC 61223-3-1.1999, IDT) YY/T 0106-2008 General Specifications for Medical Diagnostic X-ray Equipment YY/T 0291-2007 Environmental Requirements and Test Methods for Medical x-ray Equipment YY 0505-2005 Medical Electrical Equipment - Part 1-2. General Requirements for safety, Collateral Standards. Electromagnetic Compatibility Requirements and Tests (IEC 60601-1-2.2001, IDT) DICOM 3.0 Digital Imaging and Communications in Medicine (Version 3.0) 3 Terms and Definitions The following terms and definitions, and those defined in GB/T 10149 and GB/T 17857 are applicable to this Standard. 5.1.1 Environmental condition Unless otherwise is specified, the working environmental conditions of DR system shall meet. a) Ambient temperature. 10 °C ~ 40 °C; b) Relative humidity. 30% ~ 75%; c) Atmospheric Pressure. 700hPa ~ 1060hPa. 5.1.2 Power supply condition Working power supply condition of DR system shall meet. a) Mains voltage and number of phases, network voltage fluctuations specified in product standards shall not exceed ± 10% of the nominal value; b) Mains frequency. 50Hz ± 1Hz (exported products shall be specified by the manufacturer); c) Source resistance specified in product standards (specified applicable source resistance shall be no less than the specified value of Table 101 in Clause 10.2.2a) of GB 9706.3-2000); d) Source capacity specified in product standards. 5.2 Electric power 5.2.1 Maximum output electric power Product standard shall specify the combination between X-ray tube voltage and X-ray tube current that causes the maximum output electric power. 5.2.2 Nominal electric power Product standard shall specify, in case the loading time is 0.1s, X-ray tube voltage is 100kV, maximum constant electrical power output in unit of kW provided by DR system, which is regarded as the nominal electric power. If such value can’t be preselected, then closest 100kV X-ray tube voltage and closest loading time value can be used, but no less than 0.1s. Nominal electric power shall be given together with X-ray tube voltage and current, and loading time combination. 5.3 Loading factor and control 5.3.1 X-ray tub voltage X-ray tube voltage shall meet the following requirements. a) Product standard specifies the adjustment range and mode of X-ray tube voltage; b) Product standard specifies the deviation of X-ray tube voltage, but which shall conform to the requirement of Clause 50.103.1 in GB 9706.3-2000 at least. 5.3.2 X-ray tube current X-ray tube current shall meet the following requirements. a) Product standard specifies the adjustment range and mode of X-ray tube current; b) Product standard specifies the deviation of X-ray tube current, but which shall conform to the requirement of Clause 50.103.2 in GB 9706.3-2000 at least. 5.3.3 Loading time Loading time shall meet the following requirements. a) Product standard specifies the adjustment range and mode of loading time; b) Product standard specifies the deviation of loading time, but which shall conform to the requirement of Clause 50.103.3 in GB 9706.3-2000 at least. 5.3.4 Current time product Current time product shall meet the following requirements. a) As for DR system working in intermittent manner, product standard specifies the adjustment range and mode of current time product; b) Product standard specifies the deviation of current time product, but which shall conform to the requirement of Clause 50.103.4 in GB 9706.3-2000 at least. 5.3.5 Anti-overloading DR system shall be equipped with anti-overloading measures, ensure that the selection of loading factor shall not exceed the rated capacity of X-ray tube. It shall conform to the maximum loading factor combination illustrated in the operating instructions. 5.3.6 Automatic exposure rate control DR system shall have the automatic exposure control function. 5.3.7 Correspondence between X-ray filed and image receiving surface 5.5.3 Angle indicator value Deviation of angle indicator value and its actual value shall be specified by the product standard. 5.5.4 Braking force Linear motion part in the mechanical device shall have the braking device (suspending device requires neutral equilibrium except those ones that don’t’ need braking), its braking force shall be no l... ......


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