YY/T 0741-2009 (YY/T0741-2009, YYT 0741-2009, YYT0741-2009)
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Particular specifications for digital X-ray radiography system
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General specification for digital medical X-ray radiography system
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| 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 0741-2009
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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