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YY/T 0202-2009 English PDF

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YY/T 0202-2009: Specifications for medical diagnostic X-ray device for tomography
Status: Valid

YY/T 0202: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0202-2009English329 Add to Cart 3 days [Need to translate] Specifications for medical diagnostic X-ray device for tomography Valid YY/T 0202-2009
YY/T 0202-2004EnglishRFQ ASK 9 days [Need to translate] Medical diagnostic X-ray device for tomography Obsolete YY/T 0202-2004
YY/T 0202-1995English519 Add to Cart 4 days [Need to translate] (Medical X-ray tomography device) Obsolete YY/T 0202-1995

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Basic data

Standard ID YY/T 0202-2009 (YY/T0202-2009)
Description (Translated English) Specifications for medical diagnostic X-ray device for tomography
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 14,170
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY/T 0202-2004
Quoted Standard GB 9706.1-2007; GB 9706.14-1997; GB/T 10149; YY/T 0011-2007; YY/T 0076-1992; YY/T 0106-2008; YY/T 0291-2007; 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 diagnostic X-ray tomography apparatus (hereinafter referred to as tomography apparatus) the terms and definitions, classification, requirements, test methods. This standard applies to the longitudinal tomography tomography with functional diagnostic X-ray machine. This standard does not apply to computer tomography apparatus (CT) and maxillofacial tomography devices.

YY/T 0202-2009: Specifications for medical diagnostic X-ray device for tomography

---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.
Specifications for medical diagnostic X-ray device for tomography ICS 11.040.50 C43 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0202-2004 Technical conditions for medical diagnostic X - ray tomography 2009-06-16 release 2010-12-01 implementation State Food and Drug Administration issued

Foreword

This standard replaces YY/T 0202-2004 "Medical diagnostic X-ray tomography device". The main changes in this standard compared with YY/T 0202-2004 are as follows. --- modified the standard name, the "medical diagnostic X-ray tomography device" to "medical diagnostic X-ray tomography device technology Technical requirements "; --- The safety requirements should be changed to meet the requirements of GB 9706.1, GB 9706.14 and YY 0505-2005. Deleted the original Appendix A; - the inspection rules, instructions, signs, labels, packaging, transportation and storage are removed; --- Test device icon as a data Appendix A; original Appendix A to Appendix B. --- on the other content to do some text on the changes. Appendix A and Appendix B of this standard are informative. This standard is proposed by the State Food and Drug Administration. This standard by the national medical X-ray equipment and appliances standardized sub-technical committee. The drafting of this standard. Liaoning Province Medical Devices Laboratory, Neijiang Southwest Medical Equipment Co., Ltd. The main drafters of this standard. Qu Yan, Jin Di, Dong Kaiyi, Shao Qifang. This standard replaced the previous version of the standard release. YY 0202-1995, YY/T 0202-2004. Technical conditions for medical diagnostic X - ray tomography

1 Scope

This standard specifies the terminology and definitions, classification, requirements, and requirements of medical diagnostic X-ray tomography devices (hereinafter referred to as body photographic devices) experiment method. This standard is applicable to medical diagnostic X-ray machines with longitudinal tomography. This standard does not apply to computer tomography (CT) and maxillofacial tomography.

2 normative reference documents

The terms of the following documents are hereby incorporated by reference into this standard. Whichever is the date of the reference file, which is followed by all (Excluding corrigenda) or revisions do not apply to this standard, however, encourage the parties to reach an agreement under this standard Whether you can use the latest version of these files. For undated references, the latest edition applies to this standard. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB 9706.14-1997 Medical electrical equipment - Part 2. Particular requirements for the safety of ancillary equipment for X - ray equipment (Idt IEC 60601-2-32..1994) GB/T 10149 Medical X - ray equipment - Terms and symbols X - ray photography cartridges Technical specification for coating classification of metal parts YY 0076-1992 General specification for medical diagnostic X - ray machines YY/T 0106-2008 Medical environmental requirements and test methods for medical X - ray equipment YY/T 0291-2007 YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2..2001, IDT)

3 terms and definitions

The terminology and definitions established in GB/T 10149 apply to this standard, except as follows. 3.1 Can clearly absorb the vertical axis of the human body parallel to a layer or layers of tissue images, and make the other layers of the image blurred Film mode. 3.2 X-ray source assembly focus and film center to be cut surface for the rotation center, along the two parallel lines or arc for the direction of synchronous movement Of the layers of photography. 3.3 X-ray source assembly focus and film center to be cut surface for the rotation center, along the straight and curve trajectory for the direction of synchronous movement of the body Layer photography, the trajectory can be a straight line, round, oval, cycloid, spiral and so on. 3.4 X-ray imaging device with longitudinal tomography (not including X-ray tube, high voltage generator).

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