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YY/T 1476-2016 English PDF

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YY/T 1476-2016: General technical requirements for ultrasound bladder scanner
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Basic data

Standard ID YY/T 1476-2016 (YY/T1476-2016)
Description (Translated English) General technical requirements for ultrasound bladder scanner
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C41
Classification of International Standard 11.040.50; 11.040.55
Word Count Estimation 7,739
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration

YY/T 1476-2016: General technical requirements for ultrasound bladder 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.
General technical requirements for ultrasound bladder scanner ICS 11.040.50; 11.040.55 C41 People's Republic of China Pharmaceutical Industry Standard General specification for ultrasonic bladder scanner 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this text may be related to patents. The release of this text The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Standardization Technical Committee of medical ultrasound equipment standardization sub-technical committee (SAC/TC10/SC2) Go back. The drafting of this standard unit. Tianjin Mai Da Medical Technology Co., Ltd., the State Food and Drug Administration Hubei Medical Equipment Quality Supervision Supervisory center. The main drafters of this standard. Yang Jun, Jiang Shilin, Zhang Yusheng, Wang Zhijian. General specification for ultrasonic bladder scanner

1 Scope

And Rhithers. Decisionulates ON Results Results Results compositions. Rhithers. Decisionulates Decisions.s. Decisionaints.s.s. Decisions.s.s.s.s. Find The book. This standard applies to the use of three-dimensional ultrasonic volume measurement technology, specifically for measuring the amount of urine in the bladder equipment (hereinafter referred to as equipment).

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191-2008 packaging and storage icon Medical electrical equipment - Part 1. General requirements for safety GB 9706.1-2007 Ands.s.itherithers.omenicals.omenical stratospaculates Environmental requirements and test methods for medical appliances GB/T 14710-2009

3 product composition and basic parameters

3.1 Composition The manufacturer should publish the following information in the random file. a) basic composition, including all attachments and options; b) the model number, nominal frequency, type and scan mode of each probe. 3.2 basic parameters The manufacturer should publish the following information in the random file. a) bladder scanning mode; b) Type B scan range and scan frame rate (if any); c) the number of sections on which the volume calculation is based; d) Gain adjustment range (if any).

4 requirements

4.1 working conditions a) Operating temperature. 5 ℃ ~ 40 ℃, relative humidity less than 80%; b) Use voltage. --- Equipment that uses the network power supply. Net power supply voltage ± 10%, net power frequency ± 1Hz. - Equipment that use internal battery work. The manufacturer specifies the model and operating voltage range of the battery in the product standard.

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