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YY/T 0741-2009

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YY/T 0741-2009 英文版 510 购买 现货,9秒内自动发货PDF,有增值税发票。 数字化医用X射线摄影系统 专用技术条件 作废

   
标准编号: YY/T 0741-2009 (YY/T0741-2009)
中文名称: 数字化医用X射线摄影系统 专用技术条件
英文名称: General specification for digital medical X-ray radiography system
行业: 医药行业标准 (推荐)
中标分类: C43
国际标准分类: 11.040.50
字数估计: 19,179
发布日期: 2009-11-15
实施日期: 2010-12-01
引用标准: 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
起草单位: 航天恒星空间应用技术有限公司、辽宁省医疗器械检验所、上海西门子医疗器械有限公司、沈阳师范大学、北京万东医疗装备股份有限公司、深圳市安健科技有限公司、中国人民解放军总医院
归口单位: 全国医用电器标准化技术委员会医用X线设备及用具标准化分技术委员会(SAC/TC 10/SC 1)
标准依据: 国家食品药品监督管理局公告2011年第45号;行业标准备案公告2010年第2号(总第122号)
发布机构: 国家食品药品监督管理局
范围: 本标准规定了数字化医用X射线摄影系统(以下简称DR系统)的术语和定义、系统构成、要求和试验方法。本标准适用于一般X射线摄影的DR系统。包括但不仅限于采用线阵扫描或面阵扫描探测器的DR系统, 例如:采用平板探测器(FPD)的DR系统;采用面阵CCD探测器的DR系统;采用线阵扫描CCD探测器的DR系统;采用CMOS探测器的DR系统等。对于采用一个以上数字化X射线影像探测器的DR系统, 本标准适用于每一个数字化X射线影像探测器及其成像时所使用的X射线发生装置。本标准不适用于采用X射线影像增强器的系统、计算机X射线摄

YY/T 0741-2009
General specification for digital medical X-ray radiography system
ICS 11.040.50
C43
中华人民共和国医药行业标准
YY/T0741-2009
数字化医用X射线摄影系统
专用技术条件
2009-11-15发布
2010-12-01实施
国家食品药品监督管理局 发 布
前言
本标准的附录A为规范性附录,附录B、附录C和附录D均为资料性附录。
本标准由全国医用电器标准化技术委员会医用X线设备及用具标准化分技术委员会(SAC/TC10/SC1)
归口。
本标准主要起草单位:航天恒星空间应用技术有限公司、辽宁省医疗器械检验所、上海西门子医疗
器械有限公司、沈阳师范大学、北京万东医疗装备股份有限公司、深圳市安健科技有限公司、中国人民解
放军总医院。
本标准主要起草人:邹元、夏连季、刘聪智、谭大刚、卢金明、葛遗林、杜洛山。
YY/T0741-2009
数字化医用X射线摄影系统
专用技术条件
1 范围
本标准规定了数字化医用X射线摄影系统(以下简称DR系统)的术语和定义、系统构成、要求和试
验方法。
本标准适用于一般X射线摄影的DR系统。包括但不仅限于采用线阵扫描或面阵扫描探测器的
DR系统,例如:
---采用平板探测器(FPD)的DR系统;
---采用面阵CCD探测器的DR系统;
---采用线阵扫描CCD探测器的DR系统;
---采用CMOS探测器的DR系统等。
对于采用一个以上数字化X射线影像探测器的DR系统,本标准适用于每一个数字化X射线影像
探测器及其成像时所使用的X射线发生装置。
本标准不适用于采用X射线影像增强器的系统、计算机X射线摄影系统、乳腺X射线设备、牙科X
射线设备、计算机体层摄影设备及双能影像设备的DR系统。
2 规范性引用文件
下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有
的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究
是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。
GB 9706.1-2007 医用电气设备 第1部分:安全通用要求(IEC 60601-1:1988,IDT)
GB 9706.3-2000 医用电气设备 第2部分:诊断X射线发生装置的高压发生器安全专用要求
(idt IEC 60601-2-7:1998)
GB 9706.11-1997 医用电气设备 第二部分:医用诊断X射线源组件和X射线管组件安全专用
要求(idt IEC 60601-2-28:1993)
GB 9706.12-1997 医用电气设备 第一部分:安全通用要求 三.并列标准 诊断X射线设备
辐射防护通用要求(idt IEC 60601-1-3:1994)
GB 9706.14-1997 医用电气设备 第2部分:X射线设备附属设备安全专用要求(idt IEC
60601-2-32:1994)
GB 9706.15-2008 医用电气设备 第1-1部分:通用安全要求 并列标准:医用电气系统安全要
求(IEC 60601-1-1:2000,IDT)
GB/T 10149 医用X射线设备术语和符号
GB/T 10151-2008 医用诊断X射线设备 高压电缆插头、插座技术条件
GB/T 17857-1999 医用放射学术语(放射治疗、核医学和辐射剂量学设备)
GB/T 19042.1-2003 医用成像部门的评价及例行试验 第3-1部分:X射线摄影和透视系统用
X射线设备成像性能验收试验(IEC 61223-3-1:1999,IDT)
YY/T 0106-2008 医用诊断X射线机通用技术条件
YY/T 0291-2007 医用X射线设备环境要求及试验方法
YY/T0741-2009

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
数字化医用 X射线摄影系统专用技术条件
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
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 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
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
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);
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
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
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
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.
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
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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