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IEC TS 62462:2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Ultrasonics - Output Test - Guide for the maintenance of ultrasound physiotherapy systems

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

12-31-2021

Language(s)

English

Published date

05-15-2007

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Testing regimes
5 Performance testing
Annex A (informative) - Rationale for testing
Annex B (informative) - Guidance for testers
Annex C (informative) - Quantitative relative ultrasonic
        output test using temperature rise
Annex D (informative) - Quantitative relative ultrasonic
        output test using calorimetry
Annex E (informative) - Qualitative test to assess changes
        of effective radiating area
Annex F (informative) - Example of weekly test report
Annex G (informative) - Example of annual test report
Bibliography

The purpose of this technical specification is to establish standard methods for a qualitative check of the performance of ultrasound physiotherapy devices during their lifetime, and to provide guidance on calibration requirements and techniques.To ensure that the ultrasound physiotherapy equipment is in an appropriate condition for use, a regular quality check is necessary. This technical specification defines acceptance, weekly and annual checks. The acceptance test checks the delivery of the device and its performance at the start of its lifetime. The weekly check is a simple qualitative check of device operation. In the annual check, in addition to a qualitative check, a quantitative check is defined. Examples are provided of weekly and annual test reports. This report also gives guidance to the testers concerning the measurement of acoustic output. Annual testing is to be performed by a skilled tester, e.g. biomedical engineer, medical physicist, medical device service agent, commercial tester, test house, national measurement institute or manufacturer.

Committee
TC 87
DevelopmentNote
Stability Date: 2019. (07/2017)
DocumentType
Technical Specification
Pages
29
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy

Standards Relationship
NEN NPR IEC/TS 62462 : 2007 Identical
PD IEC/TS 62462:2017 Identical

08/30173423 DC : DRAFT JULY 2008 BS EN 60601-2-5 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
I.S. EN 60601-2-5:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
CSA C22.2 No. 60601.2.5:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
BS EN 60601-2-5:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
CSA C22.2 No. 60601.2.5 : 2011 : R2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
EN 60601-2-5:2015 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
IEC 60050-802:2011 International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics
IEC TR 62781:2012 Ultrasonics - Conditioning of water for ultrasonic measurements
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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