YY/T 0093-2013 English PDFUS$329.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0093-2013: Medical diagnostic X-ray image intensifier Status: Valid YY/T 0093: Historical versions
Basic dataStandard 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Chinese Standard: C43 Classification of International Standard: 11.040.50 Word Count Estimation: 14,192 Older Standard (superseded by this standard): YY/T 0093-2004 Quoted Standard: GB 9706.1-2007; GB/T 9969-2008; YY 0076-1992; YY/T 0291-2007; YY/T 0457.1-2003; YY/T 0457.2-2003; YY/T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 Table of ContentsPreface 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 9ForewordThis 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 intensifier1 ScopeThis 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 referencesThe 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 storage3 Terms and DefinitionsYY/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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0093-2013_English be delivered?Answer: Upon your order, we will start to translate YY/T 0093-2013_English as soon as possible, and keep you informed of the progress. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0093-2013?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0093-2013 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |