SIST EN 60601-2-40:1998

SLOVENSKI STANDARD
SIST EN 60601-2-40:1998
01-september-1998
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Medical electrical equipment - Part 2-40: Particular requirements for the safety of
electromyographs and evoked response equipment (IEC 60601-2-40:1998)
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit
von Elektromyographen und Geräten für evozierte Potentiale (IEC 60601-2-40:1998)
Appareils électromédicaux - Partie 2-40: Règles particulières de sécurité pour les
électromyographes et les appareils à potentiel évoqué (CEI 60601-2-40:1998)
Ta slovenski standard je istoveten z: EN 60601-2-40:1998
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-40:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998
NORME CEI
INTERNATIONALE IEC
60601-2-40
INTERNATIONAL
Première édition
STANDARD
First edition
1998-02
Appareils électromédicaux –
Partie 2-40:
Règles particulières de sécurité pour
les électromyographes et les appareils
à potentiel évoqué
Medical electrical equipment –
Part 2-40:
Particular requirements for the safety
of electromyographs and evoked
response equipment
 IEC 1998 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE Q
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-40:1998
60601-2-40 © IEC:1998 – 3 –
CONTENTS
Page
FOREWORD . 7
INTRODUCTION . 9
SECTION ONE: GENERAL
Clause
1 Scope and object . 11
2 Terminology and definitions. 13
5 Classification . 15
6 Identification, marking and documents. 15
7 Power input. 19
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification . 21
20 Dielectric strength . 21
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility . 21
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
46 Human errors . 25

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SIST EN 60601-2-40:1998
60601-2-40 © IEC:1998 – 5 –
Pages
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data . 25
51 Protection against hazardous output . 27
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
Figure 101. 29
Annexes
L – References – Publications mentioned in this Standard. 31
AA (informative) – General guidance and rationale. 33

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SIST EN 60601-2-40:1998
60601-2-40 © IEC:1998 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-40: Particular requirements for the safety
of electromyographs and evoked response 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 co-operation 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 express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, 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) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-40 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/255/FDIS 62D/272/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.
Annex AA is for information only.
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller
roman type;
– test specifications: in italic type;
– TERMS USED THROUGHOUT THE PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2
AND IN IEC 60601-1: SMALL CAPITALS.

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SIST EN 60601-2-40:1998
60601-2-40 © IEC:1998 – 9 –
INTRODUCTION
This Particular Standard amends and supplements IEC 60601-1 (second edition, 1988):
Medical electrical equipment – Part 1: General requirements for safety, as amended by its
amendment 1 (1991) and amendment 2 (1995), hereinafter referred to as the General Standard
(see 1.3).
The requirements are followed by specifications for the relevant tests.
Following the decision taken by subcommittee 62D at the meeting in Washington in 1979, a
"General guidance and rationale" section giving some explanatory notes, where appropriate,
about the more important requirements is included in annex AA.
Clauses or subclauses for which there are explanatory notes in annex AA are marked with an
asterisk (*).
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the 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.

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SIST EN 60601-2-40:1998
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MEDICAL ELECTRICAL EQUIPMENT –
Part 2-40: Particular requirements for the safety
of electromyographs and evoked response equipment
SECTION ONE: GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard applies to ELECTROMYOGRAPHS as defined in 2.1.101 and EVOKED
RESPONSE EQUIPMENT as defined in 2.1.102, hereinafter referred to as EQUIPMENT.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of
ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT as defined in 2.1.101 and 2.1.102,
respectively.
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, IEC 60601-1 is referred to in this Particular Standard either as the "General
Standard" or as the "General Requirement(s)".
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to
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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SIST EN 60601-2-40:1998
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"Addition" means that the text of the 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 references 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.
1.5 Collateral Standards
Addition:
Collateral Standards IEC 60601-1-1 as amended by its amendment 1 and IEC 60601-1-2 have
been taken into consideration in this Particular Standard (see 6.8.2 and clause 36).
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Additional definitions:
2.1.101
ELECTROMYOGRAPH
MEDICAL ELECTRICAL EQUIPMENT for the detection and analysis of biopotentials accompanying
nerve and muscle action, either spontaneously, intentionally or evoked by electrical or other
stimulation
2.1.102
EVOKED RESPONSE EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT for the detection and analysis of biopotentials resulting from an
evoking stimulus. The stimulus may be electrical, tactile, auditory, visual, olfactory, etc.
2.1.103
ELECTRICAL STIMULATOR
parts of EQUIPMENT for the application of electric currents via electrodes in direct contact with
the PATIENT, for the evoking of biopotentials or other action

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SIST EN 60601-2-40:1998
60601-2-40 © IEC:1998 – 15 –
2.1.104
PULSE DURATION
duration of the electrical stimulus pulse WAVEFORM at 50 % of the peak amplitude
2.1.105
WAVEFORM
variations in magnitude of an electrical stimulus output (in either voltage or current) as a
function of time appearing in the APPLIED PART of the ELECTRICAL STIMULATOR
2.1.106
AUDITORY STIMULATOR
parts of EQUIPMENT for the application of sound pressure from a transducer (headphone, bone
conductor or free-field) to the ear(s) of the PATIENT, for the evoking of biopotentials or other
action
2.1.107
VISUAL STIMULATOR
parts of EQUIPMENT or SYSTEM for the application of electromagnetic radiation in the visible
spectrum from a transducer to the eyes of the patient, for the evoking of biopotentials or other
action
2.1.108
BIOPOTENTIAL INPUT PART
APPLIED PART(S) of EQUIPMENT or SYSTEM for the collection of biopotentials
5 Classification
This clause of the General Standard applies except as follows:
*5.2 According to the degree of protection against electric shock:
Amendment:
Delete TYPE B APPLIED PART.
*5.6 According to the mode of operation:
Amendment:
Delete all except CONTINUOUS OPERATION.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
j) Power input

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SIST EN 60601-2-40:1998
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Amendment:
Replace the fourth paragraph by the following:
The RATED power input of mains operated EQUIPMENT shall be the maximum power input
averaged over any period of 5 s under the conditions set out in item aa) of 7.1.
*p) Output
Addition:
EQUIPMENT capable of delivering electrical stimulus outputs into a load resistance of 1 000 Ω in
excess of 10 mA r.m.s. or 10 V r.m.s. averaged over any period of 5 s shall be marked near the
electrode connections with the symbol No. 14 (see annex D of the General Standard).
6.7 Indicator lights and push-buttons
Addition:
See also 51.102.
6.8 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
Additional item:
The instructions for use shall additionally conta
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