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YY/T 0093-2013 English PDF

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YY/T 0093-2013: Medical diagnostic X-ray image intensifier
Status: Valid

YY/T 0093: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0093-2013	English	329	Add to Cart	3 days [Need to translate]	Medical diagnostic X-ray image intensifier	Valid	YY/T 0093-2013
YY/T 0093-2004	English	839	Add to Cart	6 days [Need to translate]	Medical diagnostic X-ray image intensifier	Obsolete	YY/T 0093-2004
YY 0093-1992	English	399	Add to Cart	3 days [Need to translate]	(Medical X-ray image intensifiers)	Obsolete	YY 0093-1992

PDF similar to YY/T 0093-2013

Standard similar to YY/T 0093-2013

YY/T 0128 YY/T 0106 YY/T 0292.1 YY 0096 YY/T 0095 YY/T 0094

Basic data

Standard ID	YY/T 0093-2013 (YY/T0093-2013)
Description (Translated English)	Medical diagnostic X-ray image intensifier
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C43
Classification of International Standard	11.040.50
Word Count Estimation	14,192
Older Standard (superseded by this standard)	YY/T 0093-2004
Quoted Standard	GB 9706.1-2007; GB/T 9969-2008; YY 0076-1992; YY/T 0291-2007; YY/T 0457.1-2003; YY/T 0457.2-2003; YY/T 0457.3-2003; YY/T 0457.4-2003; YY/T 0457.6-2003; YY/T 1099-2007
Regulation (derived from)	State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the diagnostic X-ray image intensifier (hereinafter referred to as booster) requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. This standard applies to the nominal incident vision o

YY/T 0093-2013: Medical diagnostic X-ray image intensifier

---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.
Medical diagnostic X-ray image intensifier ICS 11.040.50 C43 People's Republic of China pharmaceutical industry standards Replacing YY/T 0093-2004 Medical Diagnostic X-ray image intensifier Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions Classification and nomenclature 2 4 5 Requirement 2 Test Method 5 6 7 Inspection rules 9 8 signs, instructions 9 9 packaging, transport and storage of 9

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Instead of the standard YY/T 0093-2004 "Medical Diagnostic X-ray image intensifier," compared with the YY/T 0093-2004 main technical Surgery changes are as follows. --- Reference document, with instead of GB 9706.1-2007 GB 9706.1-1995; --- Reference document, with GB/T 9969-2008 instead of GB/T 9969.1-1998; --- Reference file with YY/T 0291-2007 instead of YY/T 0291-1997; --- Reference file with YY/T 1099-2007 instead of YY 91099-1999; --- Deleted the reference document YY/T 91055-1999 "Medical Devices coat of paint category. technical conditions"; --- Delete references GB 9706.12-1997 "Medical electrical equipment Part 1. General requirements for safety juxtaposition. Quasi diagnostic X-ray equipment General requirements for radiation protection "(idtIEC 60601-1-3.1994); --- Delete references GB/T 2828.1-2003 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) inspection CABLE batch inspection sampling plan (ISO 2859-1.1999, IDT); --- Delete references GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test); --- Added 33cm image intensifier requirements; --- Temperature conditions climatic environmental tests have been adjusted; --- Define the scope of products. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee on Medical Electrical medical X-ray equipment and utensils Standardization Technical Committee (SAC / TC10/SC1) centralized. This standard was drafted. Tube Co., Haitai Alvarez. The main drafters of this standard. Linbi Cheng, Zhang Xi Ming, Chen Hangzuo. This standard was first released in 2004. Medical Diagnostic X-ray image intensifier

1 Scope

This standard specifies the diagnostic X-ray image intensifier (hereinafter referred to as booster) requirements, test methods, inspection rules, marking, Manual, packaging, transportation and storage. This standard applies to nominal incident horizons of 15cm (6in), 23cm (9in), 30cm (12in), 33cm (13in) and 40cm (16in) equipped with X-ray image reduction Enhanced image intensifier tubes, including single vision and multi-vision. These products are mainly used with Supporting medical diagnostic X-ray equipment used for image conversion. This standard does not apply to flat-type or other type of booster.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB/T 9969-2008 General Industrial Product Manual YY 0076-1992 metal parts coating technology classification conditions YY/T 0291-2007 medical X-ray equipment environmental requirements and test methods YY/T 0457.1-2003 Medical electrical equipment - optical X-ray image intensifiers - Part 1. entrance field size Determine Part 2 YY/T 0457.2-2003 Medical electrical equipment - optical X-ray image intensifiers. Determination of the conversion factor YY/T 0457.3-2003 Medical electrical equipment - optical X-ray image intensifiers - Part 3. non-uniform intensity distribution Determination of uniformity Determination of image distortion. YY/T 0457.4-2003 Medical electrical equipment - optical X-ray image intensifiers - Part 4 YY/T 0457.6-2003 Medical electrical equipment - optical X-ray image intensifiers - Part 6. Department of contrast and glare Determination of the number of YY/T 1099-2007 medical X-ray equipment packaging, transport and storage

3 Terms and Definitions

YY/T 0457 defined by the following terms and definitions apply to this document. 3.1 Image intensifier imageintensifier The X-ray image is converted to the corresponding visible image and the other with energy for enhanced image brightness external device. 3.2 Limiting resolution limitingresolution For enhancing the output of the test card on the screen bright and dark stripes image by sufficient magnification observation optical system, the human eye just Every centimeter lines included in the group that can distinguish between the stripes corresponding to the number of units of lp/cm.

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