EN 60601-2-5:2000

SLOVENSKI STANDARD
01-februar-2002
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Medical electrical equipment - Part 2-5: Particular requirements for the safety of
ultrasonic physiotherapy equipment (IEC 60601-2-5:2000)
Medizinische elektrische Geräte - Teil 2-5: Besondere Festlegungen für die Sicherheit
von Ultraschall-Physiotherapiegeräten (IEC 60601-2-5:2000)
Appareils électromédicaux - Partie 2-5: Règles particulières de sécurité des appareils à
ultrasons pour physiothérapie (CEI 60601-2-5:2000)
Ta slovenski standard je istoveten z: EN 60601-2-5:2000
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 December 2000

ICS 11.040.60 Supersedes HD 395.2.5 S1:1986

English version
Medical electrical equipment
Part 2-5: Particular requirements for the safety of
ultrasonic physiotherapy equipment
(IEC 60601-2-5:2000)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-5: Règles particulières de sécurité Teil 2-5: Besondere Festlegungen
des appareils à ultrasons für die Sicherheit von Ultraschall-
pour physiothérapie Physiotherapiegeräten
(CEI 60601-2-5:2000) (IEC 60601-2-5:2000)

This European Standard was approved by CENELEC on 2000-09-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2000 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-2-5:2000 E
Page 2
Foreword
The text of document 62D/361/FDIS, future edition 2 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 was approved by CENELEC as EN 60601-2-5 on 2000-09-01.
This European Standard supersedes HD 395.2.5 S1:1986.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2001-06-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2003-09-01
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annex ZA is normative and annexes AA and ZB are informative.
Annexes ZA and ZB have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-5:2000 was approved by CENELEC as a European
Standard without any modification.
__________
Page 3
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text and the publications are listed
hereafter. For dated references, subsequent amendments to or revisions of any of these publications
apply to this European Standard only when incorporated in it by amendment or revision. For undated
references the latest edition of the publication referred to applies (including amendments).
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
Addition to annex ZA of EN 60601-1:1990/A2:1995:

IEC 60050-801 1994 International Electrotechnical Vocabulary - -
(IEV) - Chapter 801: Acoustics and
electroacoustics
IEC 60469-1 1987 Pulse techniques and apparatus - -
Part 1: Pulse terms and definitions

IEC 61102 1991 Measurement and characterisation of EN 61102 1993
ultrasonic fields using hydrophones in the
frequency range 0,5 MHz to 15 MHz

IEC 61161 1992 Ultrasonic power measurement in liquids EN 61161 1994
in the frequency range 0,5 MHz to
25 MHz
A1 1998  A1 1998
IEC 61689 1996 Ultrasonics - Physiotherapy systems - EN 61689 1996
Performance requirements and methods
of measurement in the frequency range
0,5 MHz to 5 MHz
Page 4
Annex ZB
(informative)
Other international publications mentioned in this standard
with the references of the relevant European publications
Publication Year Title EN/HD Year
Addition to annex ZB of EN 60601-1:1990/A2:1995:

IEC 60601-2-36 1997 Medical electrical equipment EN 60601-2-36 1997
Part 2: Particular requirements for the
safety of equipment for extracorporeally
induced lithotripsy
NORME CEI
INTERNATIONALE
IEC
60601-2-5
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2000-07
Appareils électromédicaux –
Partie 2-5:
Règles particulières de sécurité
des appareils à ultrasons pour physiothérapie

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

 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
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Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-2-5 IEC:2005 – 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

60601-2-5 IEC:2005 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
–––––––––––
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-5: Particular requirements for the safety 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,
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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
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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 sub-committee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition of IEC 60601-2-5 cancels and replaces the first edition published in 1984
of which it constitutes a technical revision.
This bilingual version (2005-11) replaces the English version.
The text of this 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
v
...