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 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.

Medizinische elektrische Geräte - Teil 2-5: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschall-Physiotherapiegeräten

Appareils électromédicaux - Partie 2-5: Exigences particulières pour la sécurité de base et les perfomances essentielles des appareils à ultrasons pour physiothérapie

La CEI 60601-2-5:2009 s'applique à la sécurité de base et aux performances essentielles des appareils à ultrasons pour physiothérapie employant un seul transducteur circulaire plan, non focalisé, par transducteur, produisant des faisceaux statiques perpendiculaires à la face du transducteur. La présente norme peut également être appliquée aux appareils à ultrasons pour physiothérapie utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-5. Cette édition est une révision technique. La numérotation a été révisée conformément à la CEI 60601-1:2005 (troisième édition). De plus, des caractéristiques de performance essentielle sont définies en 201.4.3.101, des indications sur la maintenance ont été ajoutées en 201.7.9.2.1, une nouvelle exigence concernant la tension de tenue a été ajoutée en 201.8.8.3. L'article traitant de l'élévation de température de la surface du transducteur, 201.11, a été modifié pour prendre en compte les conditions d'utilisation simulée. Les mesures des paramètres relatifs aux ultrasons font maintenant référence à la CEI 61689:2007 (deuxième édition). La modification la plus importante concernant les paramètres relatifs aux ultrasons est la définition 201.3.207, surface active d'émission. Cette modification touche également l'intensité effective et son incertitude.

Medicinska električna oprema - 2-5. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za opremo za ultrazvočno fizioterapijo

IEC 60601-2-5:2009 se uporablja za osnovno varnost in bistvene lastnosti ultrazvočne fizioterapevtske opreme, ki uporablja enoravninski neosrediščeni krožni pretvornik na glavo za obdelavo, ki proizvaja statične snope, pravokotne na ploskev glave za obdelavo. Ta standard se lahko uporablja tudi za ultrazvočno fizioterapevtsko opremo, ki se uporablja za lajšanje bolezni, poškodb ali invalidnosti. Tretja izdaja razveljavlja in nadomešča drugo izdajo, objavljeno leta 2000. Ta izdaja tvori tehnično popravljeno izdajo. Oštevilčenje je bilo popravljeno tako, da je v skladu s standardom IEC 60601-1:2005 (tretja izdaja). Poleg tega so bistvene lastnosti določene v točki 201.4.3.101, navodila za vzdrževanje so dodana v točki 201.7.9.2.1 in v točko 201.8.8.3 je bila dodana nova zahteva glede dielektrične odpornosti. Točka v zvezi s povišanjem temperature površine pretvornika 201.11 je bila spremenjena tako, da dopušča pogoje simulirane uporabe. Meritve z ultrazvokom povezanih parametrov se zdaj sklicujejo na standard IEC 61689:2007 (druga izdaja). Najpomembnejša sprememba z ultrazvokom povezanih parametrov je določitev dejanskega območja sevanja, 201.3.207. Ta sprememba bo vplivala tudi na vrednost dejanske intenzivnosti in njene negotovosti.

General Information

• Status: Published
• Publication Date: 22-Oct-2015
• Withdrawal Date: 14-Sep-2018
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 23-Oct-2015
• Completion Date: 23-Oct-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-5:2015 - Medical electrical equipment -- Part 2-5: Particular requirements for basic safety and essential performance of ultrasonic physiotherapy equipment

Relations

• Replaces: EN 60601-2-5:2000 - Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
1DGRPHãþD
SIST EN 60601-2-5:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]DRSUHPR]DXOWUD]YRþQRIL]LRWHUDSLMR
Medical electrical equipment -- Part 2-5: Particular requirements for basic safety and
essential performance of ultrasonic physiotherapy equipment
Appareils électromédicaux -- Partie 2-5: Exigences particulières pour la sécurité de base
et les perfomances essentielles des appareils à ultrasons pour physiothérapie
Ta slovenski standard je istoveten z: EN 60601-2-5:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-5

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.60 Supersedes EN 60601-2-5:2000
English Version
Medical electrical equipment - Part 2-5: Particular requirements
for the basic safety and essential performance of ultrasonic
physiotherapy equipment
(IEC 60601-2-5:2009)
Appareils électromédicaux - Partie 2-5: Exigences Medizinische elektrische Geräte - Teil 2-5: Besondere
particulières pour la sécurité de base et les perfomances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à ultrasons pour physiothérapie wesentlichen Leistungsmerkmale von Ultraschall-
(IEC 60601-2-5:2009) Physiotherapiegeräten
(IEC 60601-2-5:2009)
This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-5:2015 E
European foreword
The text of document 62D/693/CDV, future edition 3 of IEC 60601-2-5, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-5:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-5:2000.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-5:2009 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-36:1997 NOTE Harmonized as EN 60601-2-36:1997 (not modified).
IEC 61161:2006 NOTE Harmonized as EN 61161:2007 (not modified).
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
Addition to Annex ZA of EN 60601-1:2006:
IEC 61689 2007 Ultrasonics - Physiotherapy systems - EN 61689 2007
Field specifications and methods of
measurement in the frequency range
0,5 MHz to 5 MHz
IEC 62127-1 2007 Ultrasonics - Hydrophones - EN 62127-1 2007
Part 1: Measurement and
characterization of medical ultrasonic
fields up to 40 MHz
IEC 62127-2 2007 Ultrasonics - Hydrophones - EN 62127-2 2007
Part 2: Calibration for ultrasonic fields up
to 40 MHz
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-5 ®
Edition 3.0 2009-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-5: Particular requirements for the basic safety and essential performance
of ultrasonic physiotherapy equipment

Appareils électromédicaux –
Partie 2-5: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à ultrasons pour physiothérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
V
CODE PRIX
ICS 11.040.60 ISBN 978-2-88910-214-3
– 2 – 60601-2-5 © IEC:2009
CONTENTS
FOREWORD.0H3
INTRODUCTION.1H6
201.1 Scope, object and related standards .2H7
201.2 Normative references.3H9
201.3 Terms and definitions.4H9
201.4 General requirements.5H12
201.5 General requirements for testing of ME EQUIPMENT.6H13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .7H13
201.7 *ME EQUIPMENT identification, marking and documents .8H13
201.8 *Protection against electrical HAZARDS from ME EQUIPMENT .9H14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .10H15
201.10 Protection against unwanted and excessive radiation HAZARDS.11H15
201.11 Protection against excessive temperatures and other HAZARDS.12H16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.13H19
201.13 HAZARDOUS SITUATIONS and fault conditions.14H21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .15H21
201.15 Construction of ME EQUIPMENT .16H21
201.16 ME SYSTEMS .17H22
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .18H22
202 Electromagnetic compatibility – Requirements and tests .19H22
Annexes .20H23
Annex AA (informative) Particular guidance and rationale.21H24
Annex BB (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES .22H29
Bibliography.23H32
Index of defined terms used in this particular standard.24H33

Figure BB.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers .25H31

Table 201.101 – List of symbols.26H12
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements .27H13
Table 201.103 – Overview of the tests noted under 201.11.1.3 .28H19
Table BB.1 – Acoustic and thermal properties of tissues and materials .29H29
Table BB.2 – Weight % pure components .30H30

60601-2-5 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
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