Medical electrical equipment -- Part 2-5: Particular requirements for 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
09-Nov-2015
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Nov-2015
Due Date
10-Jan-2016
Completion Date
10-Nov-2015

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SLOVENSKI STANDARD
SIST EN 60601-2-5:2015
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
SIST EN 60601-2-5:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-5:2015
---------------------- Page: 2 ----------------------
SIST EN 60601-2-5:2015
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
---------------------- Page: 3 ----------------------
SIST EN 60601-2-5:2015
EN 60601-2-5:2015
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).
---------------------- Page: 4 ----------------------
SIST EN 60601-2-5:2015
EN 60601-2-5:2015
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
---------------------- Page: 5 ----------------------
SIST EN 60601-2-5:2015
EN 60601-2-5:2015
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.
---------------------- Page: 6 ----------------------
SIST EN 60601-2-5:2015
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
CODE PRIX
ICS 11.040.60 ISBN 978-2-88910-214-3
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN 60601-2-5:2015
– 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

---------------------- Page: 8 ----------------------
SIST EN 60601-2-5:2015
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

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-5 has been prepared by IEC subcommittee 62D:

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical

practice.

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.
---------------------- Page: 9 ----------------------
SIST EN 60601-2-5:2015
– 4 – 60601-2-5 © IEC:2009
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62D/693/CDV 62D/766/RVC

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.

– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type.

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this particular standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC

Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance

with this standard;

– “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in 31H Ann e x AA .

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.
---------------------- Page: 10 ----------------------
SIST EN 60601-2-5:2015
60601-2-5 © IEC:2009 – 5 –

The committee has decided that the contents of this publication will remain unchanged until

the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in

the data related to the specific publication. At this date, the publication will be

• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 11 ----------------------
SIST EN 60601-2-5:2015
– 6 – 60601-2-5 © IEC:2009
INTRODUCTION

In this particular standard, safety and performance requirements additional to those in the

general standard are specified for ULTRASONIC PHYSIOTHERAPY EQUIPMENT.
This particular standard takes into account IEC 61689.
The requirements are followed by specifications for the relevant tests.

A rationale for the more important requirements, where appropriate, is given in Annex AA. It is

considered that a knowledge of the reasons for these requirements will not only facilitate the

proper application of the particular standard but will, in due course, expedite any revision

necessitated by changes in clinical practice or as a result of developments in technology.

However this annex does not form part of the requirements of this standard.

The clauses and subclauses which have corresponding rationale statements are marked with

an asterisk * after their number.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-5:2015
60601-2-5 © IEC:2009 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
201.1 Scope, object and related standards
Clause 1 of the general standard 0F applies, except as follows:
201.1.1 Scope
Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as

ME EQUIPMENT.

This standard only relates to 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.

In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an

APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular

standard specifying safety requirements for the additional function.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to

ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the

case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS

within the scope of this standard are not covered by specific requirements in this standard

except in 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard.
This particular standard does not apply to:

– EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in

surgery or dentistry);

– EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates

such as stones in the kidneys or the bladder (lithotripters) (for information refer to

IEC 60601-2-36);

– ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ultrasound pulse waves are used.

—————————

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance
---------------------- Page: 13 ----------------------
SIST EN 60601-2-5:2015
– 8 – 60601-2-5 © IEC:2009
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for ULTRASONIC PHYSIOTHERAPY EQUIPMENT (as defined in
201.3.216).
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and subclause 201.2 of this particular standard.

IEC 60601-1-2 applies as modified in Clause 202. All other published collateral standards in

the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix “201” (e.g. 201.1 in this particular standard addresses the

content of Clause 1 of the general standard) or applicable collateral standard with the prefix

“20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in

this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral

standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3

collateral standard, etc.). The changes to the text of the general standard are specified by the

use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.139, additional definitions in this standard are

numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.
---------------------- Page: 14 ----------------------
SIST EN 60601-2-5:2015
60601-2-5 © IEC:2009 – 9 –

Subclauses or figures which are additional to those of a collateral standard are numbered

starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this standard" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Amendment:

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral standard: Electromagnetic compatibility –

Requirements and tests
Addition:

IEC 61689:2007, Ultrasonics – Physiotherapy systems – Field specifications and methods of

measurement in the frequency range 0,5 MHz to 5 MHz

IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterisation of

medical ultrasonic fields up to 40 MHz

IEC 62127-2:2007, Ultrasonics – Hydrophones – Part 2: Calibration for ultrasonic fields up to

40 MHz
NOTE Informative references are listed in the bibliography on page 32.
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in the general standard

and in IEC 61689 (some of which are repeated here for convenience), as well as the following

additional definitions apply:
NOTE 1 An index of defined terms is given after the Bibliography.

NOTE 2 A list of symbols used in this particular standard is found in Table 201.101.

Addition:
201.3.201
ACOUSTIC WORKING FREQUENCY
awf

frequency of an acoustic signal based on the observation of the output of a hydrophone

placed in an acoustic field. The signal is analysed using the zero-crossing frequency

technique
[IEC 61689:2007, definition 3.3, modified]
---------------------- Page: 15 ----------------------
SIST EN 60601-2-5:2015
– 10 – 60601-2-5 © IEC:2009
NOTE Acoustic frequency is expressed in hertz (Hz).
201.3.202
ATTACHMENT HEAD

ACCESSORY intended to be attached to the TREATMENT HEAD for the purpose of modifying the

ultrasonic beam characteristics
201.3.203
BEAM NON-UNIFORMITY RATIO

ratio of the square of the MAXIMUM R.M.S. ACOUSTIC PRESSURE to the spatial average of the

square of the R.M.S. ACOUSTIC PRESSURE, where the spatial average is taken over the

EFFECTIVE RADIATING AREA
[IEC 61689:2007, definition 3.9, modified]
201.3.204
BEAM TYPE

descriptive classification for the ultrasonic beam in one of three types: collimated, convergent

or divergent
[IEC 61689:2007, definition 3.11]
201.3.205
DUTY FACTOR
ratio of the PULSE DURATION to the PULSE REPETITION PERIOD
[IEC 61689:2007, definition 3.16]
201.3.206
EFFECTIVE INTENSITY
intensity given by I = P/A where P is the OUTPUT POWER and A is the EFFECTIVE
e ER ER
RADIATING AREA
NOTE Effective intensity is expressed in watt per centimetre squared (W/cm ).
[IEC 61689:2007, definition 3.17]
201.3.207
EFFECTIVE RADIATING AREA

BEAM CROSS-SECTIONAL AREA determined at a distance of 0,3 cm from the front of the

TREATMENT HEAD, A (0,3), multiplied by a dimensionless factor, equal to 1,354
BCS
[IEC 61689:2007, definition 3.19, modified]
NOTE 1 Beam cross-sectional area is expressed in centimetre squared (cm ).

NOTE 2 This may be thought of as the area of the face of the treatment head which transmits 100% of the total

mean square acoustic power.
201.3.208
OUTPUT POWER

time-average ultrasonic power emitted by a TREATMENT HEAD of ULTRASONIC PHYSIOTHERAPY

EQUIPMENT into an approximately free field under specified conditions in a specified medium,

preferably
...

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