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CENELEC
EN 60601-2-5:2015

EN 60601-2-5:2015

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

Published date

10-23-2015

Publisher

European Committee for Standards - Electrical

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and
       documents
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS
       of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
       HAZARDS
201.11 Protection against excessive temperatures and other
       HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
       and ME SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Example set-up to measure surface
         temperature of externally applied TRANSDUCER
         ASSEMBLIES
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

IEC 60601-2-5:2009 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition published in 2000. This edition constitutes a technical revision. The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this, essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in 201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to allow for simulated use conditions. Measurements of ultrasound-related parameters are now referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-related parameters is the definition of effective radiating area, 201.3.207. This change will also affect the value of the effective intensity and its uncertainty.

Committee
CLC/TC 62
DevelopmentNote
Supersedes HD 395.2.5. (05/2001)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current

EN 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
CEI EN 61689 : 2013 ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ
BS EN 61689:2013 Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
I.S. EN 61689:2013 ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ (IEC 61689:2013 (EQV))
BS EN 60601-2-62:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
EN 60601-2-62:2015 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

IEC 62127-1:2007+AMD1:2013 CSV Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz
ISO/IEC Guide 98:1993 Guide to the expression of uncertainty in measurement (GUM)
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
EN 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 60469-1:1987 Pulse techniques and apparatus. Part 1: Pulse terms and definitions
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-2-36:2015 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
EN 62127-2:2007/A2:2017 ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ
IEC TS 62462:2007 Ultrasonics - Output Test - Guide for the maintenance of ultrasound physiotherapy systems
IEC 62127-2:2007+AMD1:2013+AMD2:2017 CSV Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz
EN 62127-1:2007/A1:2013 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013)
IEC 60601-2-36:2014 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

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