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YY/T 0850-2011 English PDF

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YY/T 0850-2011: Guide for evaluation of uncertainty in measurement of ultrasonic diagnostic and monitoring equipment acoustic output characteristics
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Basic data

Standard ID YY/T 0850-2011 (YY/T0850-2011)
Description (Translated English) Guide for evaluation of uncertainty in measurement of ultrasonic diagnostic and monitoring equipment acoustic output characteristics
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C41
Classification of International Standard 11.40.55; 17.140.50
Word Count Estimation 9,989
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard GB/T 4883-2008; GB 9706.9-2008; JJF 1001-2011; JJF 1059-1999
Regulation (derived from) State Food and Drug Administration Notice No. 106 of 2011
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the ultrasonic medical diagnostic and monitoring equipment acoustic output measurement uncertainty of terms and definitions, the main source of uncertainty, uncertainty assessment procedures and uncertainty assessment, reporting and representation. This standard applies to ultrasonic medical diagnostic and monitoring equipment acoustic output measurement Uncertainty.

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


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Guide for evaluation of uncertainty in measurement of ultrasonic diagnostic and monitoring equipment acoustic output characteristics ICS 11.40.55; 17.140.50 C41 People's Republic of China pharmaceutical industry standards Ultrasound diagnostic and monitoring equipment acoustic output parameters Measurement Uncertainty Guide Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

This 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 National Standardization Technical Committee appliances medical ultrasound equipment at the Technical Committee (SAC/TC10/SC2) centralized. This standard was drafted. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Jiang Shilin, Wang Zhijian, Regulus Kai, He Yong. Ultrasound diagnostic and monitoring equipment acoustic output parameters Measurement Uncertainty Guide

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 JJF1001-2011 common measurement terms and definitions JJF1059-1999 Evaluation and Expression of Uncertainty in Measurement

3 Terms

GB 9706.9-2008, JJF1001-2011 and JJF1059-1999 defined and the following terms and definitions apply to this document. 3.1 Ultrasound diagnostic and monitoring equipment ultrasonicdiagnosticandmonitoringequipment 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 characteristicsofacousticoutput 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;

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