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YY/T 0797-2010Ultrasonics—Output test—Guide for the maintenance of ultrasound physiotherapy systems (English PDF)

超声 输出试验 超声理疗设备维修指南

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 27, 2010

Implementation date

June 1, 2012

Scope

YY/T 0797-2010 is the English-translated version of 超声 输出试验 超声理疗设备维修指南.

YY/T 0797-2010 is the Chinese pharmaceutical industry standard that describes a method for checking the output and so the performance of ultrasound physiotherapy equipment, as a guide to its maintenance.

It is addressed to those who use such equipment, among them physiotherapists, medical practitioners, chiropractors, osteopaths, beauticians, biomedical engineers and medical physicists, and it sets out the radiation force balance measurement, the frequency and timer checks and the records to be kept. Issued on 27 December 2010, it applies from 1 June 2012.

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Document preview — YY/T 0797-2010

National Standard of the People's Republic of China

Classification
C 41

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

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions

Foreword

This standard is equivalent to using the International Electrotechnical Commission standard IEC 62462:2007 "ultrasound test output ultrasonic physiotherapy equipment maintenance means south".

The standard IEC 62462 only made a very small amount of editorial changes did not affect the degree of consistency.

The Standard Appendix A, Appendix B, Appendix C, Appendix D, Appendix E, Appendix F and Appendix G are informative appendices.

Introduction

This standard is intended for the qualitative verification of the life cycle performance of ultrasonic physiotherapy equipment, establish a standardized method of verification requirements and technology Surgery method provides guidance.

To ensure that ultrasound physiotherapy equipment in normal use, the need for periodic verification. This standard specifies the acceptance inspection, weekly inspection Annual inspection and verification testing three kinds of forms. Receiving inspection and verification of device performance and the initial stage of its life cycle deliverables; weekly test is simple Qualitative checklist of equipment operation; the annual survey is a supplement to the qualitative verification, provides for quantitative verification of the content. This standard provides each Examples week inspection and annual inspection report.

This standard is also concerned about the acoustic output measurement testers are given guidelines.

Annual inspection by a skilled testers, such as biomedical engineers, medical physicists, medical equipment maintenance personnel, business testers, Test agencies, national institutions measured or manufacturers, etc. bear. Ultrasonic output test ultrasonic physiotherapy equipment Maintenance Guide

1 Scope

Users of this standard describes a method for assisting ultrasound physiotherapy equipment (hereinafter referred to as "equipment") verification of the performance of such equipment. Its main To apply to physical therapists, medical practitioners, chiropractors, bone doctors, beauticians, doctors, biomedical engineers, medical physicists, medical Spa equipment maintenance personnel, business testers, inspection agency or the manufacturer and the like.

NOTE: The names of all standard publications relates to an information listed in the references.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB 9706.7-2008 Medical electrical equipment - Part 2-5. requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5. 2000, IDT)

JJF 1059-1999 Evaluation and Expression of Uncertainty in Measurement

IEC 61689:2007 ultrasound physiotherapy equipment 0.5MHz to 5MHz frequency range of performance requirements and methods of measurement

IEC 61161:2006 Ultrasonic power measurement radiation force balances and performance requirements

3 Terms and Definitions

The following terms and definitions apply to this standard.

Note: Most definitions taken from existing IEC standards, it simplifies these are defined in this standard.

3.1 Operating frequency sound

Treatment of head abutting surface vibration rate. [See IEC 61689:2007 defined 3.3 simplifies]

Note: The typical ultrasound therapy device to work in the 0.7MHz ~ 3.3MHz frequency range, this standard does not include work in the following frequency 30kHz ~ 1MHz The rate of long-wavelength range of ultrasonic physiotherapy equipment. Sound and ultrasound usually 20kHz for the sector.

3.2 Beam uniformity coefficient

The treatment of head space ratio of the average sound intensity sound intensity sound intensity was measured at the maximum point of the ultrasonic beam is calculated and measured. Symbol. RBN [See IEC 61689:2007 defined 3.9 simplifies]

3.3 Degassed water

With a low amount of dissolved gas in water. (See IEC 61161:2006 in B.3 content)

NOTE: The sound field of ultrasonic therapy, the amount of dissolved oxygen can be reduced to 4 x 10^-6.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.7-2008 · IEC 61689:2007 · IEC 61161:2006

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