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YY/T 1476-2016General technical requirements for ultrasound bladder scanner (English PDF)

超声膀胱扫描仪通用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1476-2016 is the English-translated version of 超声膀胱扫描仪通用技术条件.

YY/T 1476-2016 is the Chinese pharmaceutical industry standard that sets the general technical requirements for the ultrasound bladder scanner, the device that measures the volume of urine in the bladder by three-dimensional ultrasonic volume measurement.

It covers the accuracy of the measured volume over the declared range and how it is verified with a phantom, the probe and its acoustic output, the display and the storage of the result, the power supply and the electrical safety of the equipment. Issued on 26 January 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1476-2016

National Standard of the People's Republic of China

ICS: 11.040.50; 11.040.55
Classification: C 41

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative reference documents
3 Product composition and basic parameters
4 Requirements

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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 °C ~ 40 °C, 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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 191-2008Graphical symbols marking for handling and storage of packages

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