SIST EN 60601-2-5:2002

SLOVENSKI STANDARD
SIST EN 60601-2-5:2002
01-februar-2002
1DGRPHãþD
SIST HD 395.2.5 S1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
XOWUD]YRþQRSVLKRWHUDSHYWVNRRSUHPR,(&
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
SIST EN 60601-2-5:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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

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Page 2
EN 60601-2-5:2000
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.
__________

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Page 3
EN 60601-2-5:2000
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

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Page 4
EN 60601-2-5:2000
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

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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

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Pour prix, voir catalogue en vigueur
For price, see current catalogue

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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

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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,
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 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
voting indicated in the above table.

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60601-2-5 IEC:2005 – 7 –
The French version of this standard has not been voted upon.
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, headings of subclauses and headings of items: 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 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.

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60601-2-5 IEC:2005 – 9 –
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.

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60601-2-5 IEC:2005 – 11 –
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.

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60601-2-5 IEC:2005 – 13 –
“Addition” means that the text of this Particular Standard is additional to the requirements of
the General Standard.
“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 General Standard
and Collateral Standards mentioned below.
1.5 Collateral Standards
Addition:
The following Collateral Standards apply:
IEC 60601-1-1:1992, Medical electrical equipment – Part 1: General requirements for safety –
Section 1 – Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4. Collateral Standard: Programmable electrical medical systems
2 Terminology and definitions
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
Additional definitions:
2.1.101
ULTRASONIC PHYSIOTHERAPY EQUIPMENT (hereinafter referred to as EQUIPMENT)
EQUIPMENT for the generation and application of ULTRASOUND to a PATIENT for therapeutic
purposes
NOTE Essentially the EQUIPMENT comprises a generator of electric high-frequency power and a transducer for
converting this to ULTRASOUND.
2.1.102
ULTRASONIC TRANSDUCER
device capable of converting electrical energy to mechanical energy within the ultrasonic
frequency range

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60601-2-5 IEC:2005 – 15 –
*2.1.103
TREATMENT HEAD
assembly comprising an ULTRASONIC TRANSDUCER and associated parts for local application of
ULTRASOUND to the PATIENT
NOTE A TREATMENT HEAD is also referred to as an applicator.
2.1.104
ATTACHMENT HEAD
ACCESSORY intended to be attached to the TREATMENT HEAD for the purpose of modifying the
ultrasonic beam characteristics
2.12  MISCELLANEOUS
2.12.101
RATED OUTPUT POWER
maximum OUTPUT POWER of the EQUIPMENT at any RATED MAINS VOLTAGE
[IEC 61689, definition 3.32]
2.12.102
ULTRASOUND
acoustic oscillation whose frequency is above the high-frequency limit of audible sound (about
16 kHz) (see 801-21-04 of IEC 60050(801))
[IEC 61689, definition 3.45]
2.12.103
EFFECTIVE RADIATING AREA
beam cross-sectional area extrapolated to the front face of the TREATMENT HEAD and multiplied
by a dimensionless factor according to IEC 61689
[IEC 61689, definition 3.20, modified]
NOTE This may be thought of as the area of the face of the treatment head which contains 100 % of the total
mean square acoustic power.
2.12.104
EFFECTIVE INTENSITY
ratio of the OUTPUT POWER to the EFFECTIVE RADIATING AREA. It is expressed in watts per square
centimetre
[IEC 61689, definition 3.18, modified]
2.12.105
ACOUSTIC WORKING FREQUENCY
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 (see
3.4.1 of IEC 61102)
[IEC 61689, definition 3.3]
2.12.106
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, determined in accordance with IEC 61689
[IEC 61689, definition 3.9, modified]

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60601-2-5 IEC:2005 – 17 –
2.12.107
BEAM TYPE
descriptive classification for the ultrasonic beam in one of three types: collimated, convergent
or divergent
[IEC 61689, definition 3.11]
2.12.108
DUTY FACTOR
ratio of the PULSE DURATION to the PULSE REPETITION PERIOD (see 5.3.2.4 of IEC 60469-1)
[IEC 61689, definition 3.17]
2.12.109
OUTPUT POWER
time-average ultrasonic power radiated by a TREATMENT HEAD of EQUIPMENT into an approxi-
mately free field under specified conditions in a specified medium, preferably in water (see 3.5
of IEC 61161)
[IEC 61689, definition 3.31]
2.12.110
PULSE DURATION
time interval beginning at the first time the pressure amplitude exceeds a reference value and
ending at the last time the pressure amplitude returns to that value. The reference value is
equal to the sum of the minimum pressure amplitude and 10 % of the difference between the
maximum and minimum pressure amplitude
[IEC 61689, definition 3.35]
NOTE The above definition from IEC 61689 differs from that of 3.30 of IEC 61102 to account for incomplete
modulation.
2.12.111
PULSE REPETITION PERIOD
absolute value of the time interval after which the same characteristics of a periodic waveform
recur (see 5.3.2.1 of IEC 60469-1)
[IEC 61689, definition 3.36]
2.12.112
TEMPORAL-MAXIMUM INTENSITY
in the case of an amplitude modulated wave, this is the ratio of the TEMPORAL-MAXIMUM OUTPUT
POWER to the EFFECTIVE RADIATING AREA
[IEC 61689, definition 3.41, modified]
2.12.113
TEMPORAL-MAXIMUM OUTPUT POWER
in the case of an amplitude modulated wave, this is a function of the actual OUTPUT POWER, the
temporal-peak acoustic pressure and the r.m.s. acoustic pressure and is determined as
specified in IEC 61689
[conforms to 3.34 of IEC 61689]

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60601-2-5 IEC:2005 – 19 –
*4 General requirements for tests
This clause of the General Standard applies, except as follows:
*4.1 Tests
Note addition to rationale (see Annex AA).
5 Classification
This clause of the General Standard applies, except as follows:
5.6
Amendment:
Delete all dashed items except “– CONTINUOUS OPERATION”.
*6 Identification, marking and documents
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
p) Output
Replacement:
1. The generator of an EQUIPMENT shall additionally be provided with the following markings:
− ACOUSTIC WORKING FREQUENCY in MHz (in kHz for frequencies below 1 MHz)
− waveform (continuous, amplitude modulated (or pulsed))
− if amplitude modulated (or pulsed), a description or picture of the output waveforms,
along with values for the PULSE DURATION, PULSE REPETITION PERIOD, and DUTY FACTOR
for each modulation setting.
2. The generator shall carry a nameplate, permanently attached, on which is given a unique
serial number so that it is individually identified.
3. The treatment head shall be marked with its rated output power in watts, the effective
radiating area in square centimetres, the beam non-uniformity ratio, the beam type, a
designation of the specific generator (where applicable, see 6.8.2 aa) item 9) of the
equipment for which the treatment head is intended and a unique serial number.
6.8.2 Instructions for use
Additional item:
aa) The instructions for use shall additionally contain the following:
1) Information on ACOUSTIC WORKING FREQUENCY or FREQUENCIES in kilohertz or megahertz
and EFFECTIVE RADIATING AREA or AREAS in square centimetres of any TREATMENT HEAD or
ATTACHMENT HEAD.
2) A recommendation calling the USER's attention to the need for periodic maintenance,
especially:
− INTERVALS FOR REGULAR PERFORMANCE TESTING AND CALIBRATION BY THE USER;
− INSPECTION OF THE TREATMENT HEAD FOR CRACKS, WHICH MAY ALLOW THE INGRESS OF
CONDUCTIVE FLUID;
− INSPECTION OF THE TREATMENT HEAD CABLES AND ASSOCIATED CONNECTORS.

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60601-2-5 IEC:2005 – 21 –
3) Advice on the procedures necessary for safe operation, drawing attention in the case of
TYPE B APPLIED PARTS to the SAFETY HAZARDS which may occur as a result of an inadequate
electrical installation.
4) Advice on the type of electrical installation to which the EQUIPMENT may be safely
connected, including the connection of any POTENTIAL EQUALIZATION CONDUCTOR.
5) Advice drawing the USER’s attention to the need for care when handling the TREATMENT
HEAD since rough handling may adversely affect its characteristics.
6) A list of conditions for which ULTRASOUND treatment is contraindicated.
7) A statement of intended use(s).
8) Information on available TREATMENT HEADS.
9) Where a TREATMENT HEAD has been designed for interchangeability, such that it is not
possible to specify a particular generator unit, this shall be stated and the method by which
interchangeability is achieved shall be described.
7 Power input
This clause of the General Standard applies with EQUIPMENT operated as specified in Clause 50.

SECTION TWO – ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply.

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply, except as follows:
*13 General
Addition:
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.

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply, except as follows:
21 Mechanical strength
21.5 Compliance test:
Additional paragraph:
After the test, the TREATMENT HEAD shall comply with 51.104 of this Particular Standard.

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60601-2-5 IEC:2005 – 23 –
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard apply, except as follows:
*35 Acoustical energy (including ult
...