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YY/T 0850-2011Guide for evaluation of uncertainty in measurement of ultrasonic diagnostic and monitoring equipment acoustic output characteristics (English PDF)

超声诊断和监护设备声输出参数测量不确定度评定指南

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY/T 0850-2011 is the English-translated version of 超声诊断和监护设备声输出参数测量不确定度评定指南.

YY/T 0850-2011 is the Chinese pharmaceutical industry standard that guides the evaluation of the uncertainty in the measurement of the acoustic output characteristics of ultrasonic diagnostic and monitoring equipment.

It gives the terms and definitions, lists the main sources of uncertainty, sets out the procedure by which the uncertainty is assessed and evaluated and fixes the way it is reported and expressed. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY/T 0850-2011

National Standard of the People's Republic of China

ICS
11.40.55; 17.140.50
Classification
C 41

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms
  • 4 Measurement Uncertainty assessment procedures

Foreword

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

1 Scope

This standard specifies the ultrasound diagnostic and monitoring equipment acoustic output parameter measurement uncertainty of terms and definitions, the main sources of uncertainty, Uncertainty assessment procedures and uncertainty evaluation, reporting and representation.

This standard applies to the ultrasound diagnostic and monitoring equipment (hereinafter referred to as "equipment") sound output parameter measurement Uncertainty Evaluation.

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.

Analyzing and processing GB/statistical processing and interpretation of normal sample outliers T 4883-2008 data

GB 9706.9-2008 Medical electrical equipment - Part 2-37. Ultrasound diagnostic and monitoring equipment requirements for the safety JJF 1001-2011 common measurement terms and definitions JJF 1059-1999 Evaluation and Expression of Uncertainty in Measurement

3 Terms

GB 9706.9-2008, JJF 1001-2011 and JJF 1059-1999 defined and the following terms and definitions apply to this document.

3.1 Ultrasound diagnostic and monitoring equipment

For medical diagnosis, monitoring the use of ultrasound on human inspection medical electrical equipment.

Note: adapted from GB 9706.9-2008, the definition 2.1.145.

3.2 Acoustic output parameters

Describe the sound field characteristic of a number of parameters. The standard refers specifically to the sound field of ultrasonic sound field.

4 Measurement Uncertainty assessment procedures

Measured 4.1 Description When measured general description shall include the following.

a) The test procedure is described;

b) affect the measured parameters to be measured and clear units, measuring/test basis;

c) the relationship between the parameters to be measured and its influence (input), the mathematical model, given the measured parameters y and xi influence the relationship. y = f (X1, X2, X3)

Depending on the nature of the mathematical model to determine the combined standard uncertainty of the applicable formula can be omitted if the calculation and dissemination be measured coefficient. School d) the known systemic effects of positive value;

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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