YY 0849-2011 English PDFUS$439.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0849-2011: Ophthalmic high frequency ultrasound scanner Status: Obsolete
Basic dataStandard ID: YY 0849-2011 (YY0849-2011)Description (Translated English): Ophthalmic high frequency ultrasound scanner Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C32;C41 Classification of International Standard: 11.040.50; 11.040.70 Word Count Estimation: 11,197 Date of Issue: 2011-12-31 Date of Implementation: 2013-06-01 Quoted Standard: GB/T 191-2008; GB 9706.1-2007; GB 9706.9-2008; GB 9706.15-2008; GB/T 14710-2009; YY 0773-2010 Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the frequency ultrasound diagnostic ophthalmic product composition and basic parameters, requirements, test methods and inspection rules. This standard applies to the frequency of 30 MHz ~ 50 MHz high-frequency ultrasound ophthalmic diagnostic (hereinafter referred to as the device), the device is often called ultrasound biomicroscopy UBM (ultrasound biomicroscope). YY 0849-2011: Ophthalmic high frequency ultrasound scanner---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.Ophthalmic high frequency ultrasound scanner ICS 11.040.50; 11.040.70 C41; C32 People's Republic of China pharmaceutical industry standards Ophthalmic high frequency ultrasound diagnostic Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard was proposed by the State Food and Drug Administration. This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2) Centralized. This standard was drafted. Tianjin Medical Technology Co., Ltd. Madain, the State Food and Drug Administration of Quality Supervision, Inspection Hubei Medical Devices Test center. The main drafters. Zhang Yusheng, Jiang Shilin, Yan-group, Yang Jun, Wang Zhijian. Ophthalmic high frequency ultrasound diagnostic1 ScopeThis standard specifies the high-frequency ultrasound diagnostic ophthalmic composition of the product and basic parameters, requirements, test methods and inspection rules. This standard applies to the frequency of 30MHz ~ 50MHz ophthalmic high frequency ultrasound diagnostic apparatus (hereinafter referred to as the device), the device is usually Called UBM UBM (ultrasoundbiomicroscope).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/T 191-2008 Packaging - Pictorial signs GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB 9706.9-2008 Medical electrical equipment - Part 2-37. Ultrasound diagnostic and monitoring equipment requirements for the safety GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. medical electrical systems security Claim GB/T 14710-2009 Medical electrical equipment environmental requirements and test methods YY 0773-2010 ophthalmic B-type ultrasonic diagnostic apparatus General technical conditions3 equipment components and basic parameters3.1 Composition The manufacturer shall publish the following information in a random file. a) basic components, including all attachments and options; b) each probe type, model, nominal frequency, focus and imaging mode. 3.2 Basic parameters The manufacturer should publish the following information about the device in the product standard. a) The nominal operating frequency ultrasound; b) the nominal focal length; c) gray scale; d) scanning frame rate; e) scanning range (width × depth); f) Gain adjustment range (if any); g) after image processing and signal processing mode (if any); h) digital scan converter (DSC) capacity (if any); i) the depth and adjust the display delay Step (if any). ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0849-2011_English be delivered?Answer: Upon your order, we will start to translate YY 0849-2011_English as soon as possible, and keep you informed of the progress. 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