YY/T 0797-2010 English PDF

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YY/T 0797-2010: Ultrasonics. Output test. Guide for the maintenance of ultrasound physiotherapy systems
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0797-2010	454	Add to Cart	4 days	Ultrasonics. Output test. Guide for the maintenance of ultrasound physiotherapy systems	Valid

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Basic data

Standard ID: YY/T 0797-2010 (YY/T0797-2010)
Description (Translated English): Ultrasonics. Output test. Guide for the maintenance of ultrasound physiotherapy systems
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C41
Classification of International Standard: 11, 040, 50
Word Count Estimation: 23,229
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB 9706.7-2008; JJF 1059-1999; IEC 61689-2007; IEC 61161-2006
Adopted Standard: IEC 62462-2007, IDT
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): State Food and Drug Administration
Summary: This standard applies to assist ultrasonic physiotherapy equipment (hereinafter referred to as "equipment") user verification of the performance of such devices. Which is mainly applied to physical therapists, medical practitioners, chiropractors, orthopedic doctors, beauticians, doctors, biomedical engineers, medical physicists, medical equipment maintenance personnel, commercial side test personnel, inspection agency or the manufacturer and so on.

YY/T 0797-2010: Ultrasonics. Output test. Guide for the maintenance of ultrasound physiotherapy systems

---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.
Ultrasonics.Output test.Guide for the maintenance of ultrasound physiotherapy systems ICS 11.040.50 C41 People's Republic of China pharmaceutical industry standards Ultrasonic output test Ultrasonic physiotherapy equipment Maintenance Guide (IEC 62462.2007, IDT) Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued

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. This standard was proposed by the State Food and Drug Administration. This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee 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. Wang Zhijian, Jiang Shilin.

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) JJF1059-1999 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 acousticworkingfrequency 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 beamnon-uniformityratio 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 degassedwater 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 × 10-6. ......

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