IEC 60601-2-5:2000

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

This Particular Standard specifies requirements and tests for the safety of ultrasonic physiotherapy equipment. It amends and supplements IEC 60601-1 (second edition, 1988) including Amendments 1 and 2, hereinafter referred to as the General Standard. This Particular Standard takes into account IEC 60601-1-2 and IEC 61689.

Appareils électromédicaux - Partie 2-5: Règles particulières de sécurité des appareils à ultrasons pour physiothérapie

La présente Norme Particulière spécifie les exigences et les essais pour la sécurité des appareils à ultrasons pour physiothérapie. Elle modifie et complète la CEI 60601-1 (deuxième édition, 1988) y compris les Amendements 1 et 2, appelée Norme Générale dans la présente Norme. La présente Norme Particulière prend en compte la CEI 60601-1-2 et la CEI 61689.

General Information

• Status: Published
• Publication Date: 12-Jul-2000
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 30-Jul-2009

Relations

• Revised: IEC 60601-2-5:2009 - Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-5
Second edition
2000-07
Medical electrical equipment –
Part 2-5:
Particular requirements for the safety of
ultrasonic physiotherapy equipment
Appareils électromédicaux –
Partie 2-5:
Règles particulières de sécurité des appareils
à ultrasons pour physiothérapie

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
60601-2-5
Second edition
2000-07
Medical electrical equipment –
Part 2-5:
Particular requirements for the safety of
ultrasonic physiotherapy equipment
Appareils électromédicaux –
Partie 2-5:
Règles particulières de sécurité des appareils
à ultrasons pour physiothérapie

 IEC 2000  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
R
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-5 © IEC:2000(E)
CONTENTS
Page
FOREWORD . 3

INTRODUCTION .5

Clause
SECTION ONE – GENERAL
1 Scope and object. 6

2 Terminology and definitions . 7
4 General requirements for tests. 9

5 Classification . 9
6 Identification, marking and documents . 9
7 Power input . 10
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General . 11
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 11
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM
UNWANTED OR EXCESSIVE RADIATION
35 Acoustical energy (including ultrasonics) . 11
36 Electromagnetic compatibility. 12
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures. 12
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility . 13
SECTION EIGHT – ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT

50 Accuracy of operating data. 13
51 Protection against hazardous output . 14
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly. 15
Figure 101. 16
Appendix L . 17
Annex AA - General guidance and rationale . 18

60601-2-5 © IEC:2000(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION

–––––––––––
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-5: Particular requirements for the safety of

ultrasonic physiotherapy equipment

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to
promote international cooperation on all questions concerning standardization in the electrical and electronic
fields. To this end and in addition to other activities, the IEC publishes International Standards. 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. The 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 the IEC on technical matters, prepared by technical committees on
which all the National Committees having a special interest therein are represented, express, as nearly as
possible, an international consensus of opinion on the subjects dealt with.
3) They have the form of recommendations for international use published in the form of standards, technical
specifications, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
6) The IEC has not laid down any procedure concerning marking as an indication of approval and has no
responsibility when an item of equipment is declared to comply with one of its standards.
International Standard IEC 60601-2-5 has been prepared by sub-committee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1984, and constitutes a
technical revision.
The text of this Particular Standard is based on the following documents:

FDIS Report on voting
62D/361/FDIS 62D/366/RVD
Full information on the voting for the approval of this 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 3.
Annex AA is for information only.

– 4 – 60601-2-5 © IEC:2000(E)
In this Particular Standard the following print types are used:

– requirements, compliance with which can be tested, and definitions: roman type;

– notes, explanations, advice, introductions, general statements, exceptions and references: smaller
type;
– test specifications: italic type;

–TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL

CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2005. At this date, the publication will be:

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

60601-2-5 © IEC:2000(E) – 5 –
INTRODUCTION
This Particular Standard specifies requirements and tests for the safety of ULTRASONIC

PHYSIOTHERAPY EQUIPMENT. It amends and supplements IEC 60601-1 (second edition, 1988)

including Amendments 1 and 2, hereinafter referred to as the General Standard. This Particular

Standard takes into account IEC 60601-1-2 and IEC 61689.

A first edition of this Particular Standard was published in 1984, based on the first edition

(1977) of IEC 60601-1 and making reference to IEC 60150. The aim of this second edition is to

bring this Particular Standard up to date with reference to the publications and documents

mentioned above. The title has been changed to better reflect its scope based on

developments in the therapeutic application of ultrasound and in line with changes in the above
IEC standards.
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 * before their number.

– 6 – 60601-2-5 © IEC:2000(E)
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-5: Particular requirements for the safety of

ultrasonic physiotherapy equipment

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply, except as follows:

1 Scope and object
1.1 Scope
Addition:
This Particular Standard specifies the requirements for safety of ULTRASONIC PHYSIOTHERAPY
EQUIPMENT used in medical practice, as defined in 2.1.101.
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 conglom-
erates such as stones in the kidneys or the bladder (lithotrites) (for information refer to
IEC 60601-2-36);
– ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND pulse waves are
used.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of
ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:

General requirements for safety, as amended by its amendment 1 (1991) and amendment 2
(1995).
For brevity, Part 1 is referred to in this Particular Standard as the “General Standard” .
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. 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 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.
60601-2-5 © IEC:2000(E) – 7 –
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.

Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

The term “this standard” is used to make reference to the General Standard and this Particular
Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the

section, clause or subclause of the General Standard, although possibly not relevant, applies

without modification; where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
The requirements of this Particular Standard take priority over those of the Gene
...

IEC 60601-2-5
Edition 2.0 2000-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy
equipment
Appareils électromédicaux –
Partie 2-5: Règles particulières de sécurité des appareils à ultrasons pour
physiothérapie
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by

any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or

IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.

Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette

publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]
IEC 60601-2-5
Edition 2.0 2000-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy
equipment
Appareils électromédicaux –
Partie 2-5: Règles particulières de sécurité des appareils à ultrasons pour
physiothérapie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
R
CODE PRIX
ICS 11.040.60 ISBN 2-8318-8312-1
– 2 – 60601-2-5 © CEI:2000
SOMMAIRE
AVANT-PROPOS .4

INTRODUCTION.8

SECTION UN – GÉNÉRALITÉS
1 Domaine d’application et objet.10

2 Terminologie et définitions.12

4 Exigences générales relatives aux essais .18

5 Classification .18

6 Identification, marquage et documentation.18

7 Puissance absorbée.20

SECTION DEUX – CONDITIONS D'ENVIRONNEMENT

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS
ÉLECTRIQUES
13 Généralités .20

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES
21 Résistance mécanique .20

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS
AUX RAYONNEMENTS NON DÉSIRÉS OU EXCESSIFS
35 Énergie acoustique (y compris les ultrasons) .22
36 Compatibilité électromagnétique.22

SECTION SIX – PROTECTION CONTRE LES RISQUES D’ALLUMAGE
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET LES AUTRES RISQUES
42 Températures excessives.24
44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage,
stérilisation, désinfection et compatibilité .24

SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTERISTIQUES DE SORTIE PRESENTANT

DES RISQUES
50 Précision des caractéristiques de fonctionnement.26
51 Protection contre les caractéristiques de sortie présentant des risques .26

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D'ENVIRONNEMENT
SECTION DIX – RÈGLES DE CONSTRUCTION
56 Composants et ensembles .30

Figure 101 .30

Annexe L .32
Annexe AA – Guide et justifications .34

60601-2-5 ©IEC:2000 – 3 –
CONTENTS
FOREWORD.5

INTRODUCTION.9

SECTION ONE – GENERAL
1 Scope and object .11

2 Terminology and definitions.13

4 General requirements for tests .19

5 Classification .19

6 Identification, marking and documents.19

7 Power input.21

SECTION TWO – ENVIRONMENTAL CONDITIONS

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General.21

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength .21

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM
UNWANTED OR EXCESSIVE RADIATION
35 Acoustical energy (including ultrasonics) .23
36 Electromagnetic compatibility .23

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures .25
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.25

SECTION EIGHT – ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .27

51 Protection against hazardous output .27

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .31

Figure 101 .31

Appendix L.33
Annex AA - General guidance and rationale.35

– 4 – 60601-2-5 © CEI:2000
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE

–––––––––––
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-5: Règles particulières de sécurité

des appareils à ultrasons pour physiothérapie

AVANT-PROPOS
1) La Commission Electrotechnique Internationale (CEI) est une organisation mondiale de normalisation composée
de l'ensemble des comités électrotechniques nationaux (Comités nationaux de la CEI). La CEI a pour objet de
favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de
l'électricité et de l'électronique. A cet effet, la CEI – entre autres activités – publie des Normes internationales,
des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au public (PAS) et des
Guides (ci-après dénommés "Publication(s) de la CEI"). Leur élaboration est confiée à des comités d'études,
aux travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec la CEI, participent également aux
travaux. La CEI collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des
conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de la CEI concernant les questions techniques représentent, dans la mesure
du possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de la CEI
intéressés sont représentés dans chaque comité d’études.
3) Les Publications de la CEI se présentent sous la forme de recommandations internationales et sont agréées
comme telles par les Comités nationaux de la CEI. Tous les efforts raisonnables sont entrepris afin que la CEI
s'assure de l'exactitude du contenu technique de ses publications; la CEI ne peut pas être tenue responsable de
l'éventuelle mauvaise utilisation ou interprétation qui en est faite par un quelconque utilisateur final.
4) Dans le but d'encourager l'uniformité internationale, les Comités nationaux de la CEI s'engagent, dans toute la
mesure possible, à appliquer de façon transparente les Publications de la CEI dans leurs publications
nationales et régionales. Toutes divergences entre toutes Publication
...