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YY/T 0347-2009: Particular specifications for mini medical diagnostic X-ray equipment
Status: Valid YY/T 0347: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0347-2009 | English | 169 |
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Particular specifications for mini medical diagnostic X-ray equipment
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YY/T 0347-2009
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| YY/T 0347-2002 | English | RFQ |
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General specifications for medical diagnostic X-ray microequipment
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YY/T 0347-2002
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PDF similar to YY/T 0347-2009
Basic data | Standard ID | YY/T 0347-2009 (YY/T0347-2009) | | Description (Translated English) | Particular specifications for mini medical diagnostic X-ray equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 7,75 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | Older Standard (superseded by this standard) | YY/T 0347-2002 | | Quoted Standard | GB 9706.1-2007; GB 9706.3-2000; GB 9706.11-1997; GB 9706.12-1997; GB 9706.14-1997; GB/T 10149; YY 0076-1992; YY/T 0106-2008; YY/T 0291-2007; YY 0292.1-1997; YY 0505-2005 | | Regulation (derived from) | Industry standard filing Notice 2009 No. 9 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the miniature medical diagnostic X-ray machine (hereinafter referred to as microcomputers) the terms and definitions, classification and composition, requirements and test methods. This standard applies to the following tube current in 1000��A video receiver with a portable medical diagnostic X-ray machine. | YY/T 0347-2009: Particular specifications for mini medical diagnostic X-ray equipment---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Particular specifications for mini medical diagnostic X-ray equipment
ICS 11.040.50
C43
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0347-2002
Micro Medical Diagnostic X-ray machine for the technical conditions
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
Instead of the standard YY/T 0347-2002 "mini-medical diagnostic X-ray machine general technical conditions."
Compared with the standard YY/T 0347-2002 The main changes are as follows.
--- Safety requirements should be changed to comply with GB 9706.1, GB 9706.3, GB 9706.11, GB 9706.12, GB requirements of 9706.14.
Removed Appendix A;
--- Modify the standard name, the "mini-medical diagnostic X-ray machine general technical conditions" to "micro-diagnostic X-ray machine designed
Technical conditions ";
--- Because YY/T 91055-1999 "paint coating medical devices classified technical conditions" obsolete, the reference standard delete this
standard;
--- Remove the 5.12 Environmental test methods in Table 1;
--- Remove the inspection rules, manual, signs, labeling requirements, packaging, transportation and storage;
--- Modified tube voltage deviation, tube current deviation, load time deviation test methods;
--- Supplementary radiation leakage under Article loading conditions;
--- Effective field of view display size to the size of the effective field of vision;
--- The focus skin distance from the screen to focus and focus skin distance;
--- Adds additional shield requirements.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical X-ray equipment and utensils Standardization Technical Committee.
This standard was drafted. Liaoning Provincial Medical Device Testing.
The main drafters of this standard. Qu Yan, Wang Che, Yanyu Xiu.
The standard standard replaces the previous editions as. YY/T 0347-2002.
Micro Medical Diagnostic X-ray machine for the technical conditions
1 Scope
This standard specifies the miniature diagnostic X-ray machine (hereinafter referred to as microcomputer) terms and definitions, classification and composition, requirements and test
method.
This standard applies to facilitate tube current image with the receiver in the following 1000μA portable medical diagnostic X-ray machine.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.3-2000 Medical electrical equipment - Part 2. High-voltage generator safety device requirements for diagnostic X-ray generator
(Idt IEC 60601-2-7.1998)
GB 9706.11-1997 Medical electrical equipment - Part II. diagnostic X-ray source assemblies and X-ray tube assemblies
Requirements (idt IEC 60601-2-28.1993)
GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety. Collateral standard diagnostic X-ray equipment
General requirements for radiation protection (idt IEC 60601-1-3.1994)
GB 9706.14-1997 Medical electrical equipment - Part 2. X-ray equipment ancillary equipment requirements for the safety (idt IEC 60601-
2-32.1994)
GB/T 10149 X-ray equipment for medical terminology and symbols
YY 0076-1992 metal parts coating technology classification conditions
YY/T 0106-2008 medical diagnostic X-ray machine general technical conditions
YY/T 0291-2007 medical X-ray equipment environmental requirements and test methods
YY 0292.1-1997 Medical Diagnostic X-ray radiation protection appliances - Part 1. Determination of attenuation properties of materials (idt IEC 1331-1.
1994)
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2.2001, IDT)
3 Terms and Definitions
Terms and definitions GB/T 10149 apply to this standard established.
4 Classification and composition
4.1 Classification
Perspective can be divided according to the functions and features microcomputer shooting function microcomputer.
4.2 Composition
Devices, X-ray image receptor, chassis and other components generated by the X-ray microcomputer mainly.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified, the microcomputer working conditions should be met.
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