SIST EN 60601-2-10:2015

Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012)

This International Standard specifies the requirements for the safety of nerve and muscle
STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine,
hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve
STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS).
NOTE A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR.
The following ME EQUIPMENT is excluded:
– ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes;
– ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME
EQUIPMENT);
– ME EQUIPMENT intended for neurological research;
– external cardiac pacemakers (see IEC 60601-2-31);
– ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40);
– ME EQUIPMENT intended for electromyography (see IEC 60601-2-40);
– ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).

Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Stimulation von Nerven und Muskeln (IEC 60601-2-10:2012)

Appareils électromédicaux - Partie 2-10: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs de nerfs et de muscles (IEC 60601-2-10:2012)

La CEI 60601-2-10:2012 spécifie des exigences pour la sécurité de base et les performances essentielles  des stimulateurs de nerfs et de muscles, utilisés dans la pratique de la médecine physique. Ceci comprend les neurostimulateurs électriques transcutanés (TENS) et les stimulateurs de muscles électriques (EMS). Cette deuxième édition annule et remplace la première édition parue en 1987 et son amendement 1 (2001). Elle constitue une révision technique et est alignée sur la CEI 60601-1:2005+A1:2012.

Medicinska električna oprema - 2-10. del: Posebne zahteve za osnovno varnost in bistvene lastnosti živčnih in mišičnih stimulatorjev (IEC 60601-2-10:2012)

Ta mednarodni standard navaja zahteve za varnost živčnih in mišičnih STIMULATORJEV, opredeljenih v podpoglavju 201.3.204, za uporabo v fizični medicini (v nadaljevanju: ELEKTROMEDICINSKA OPREMA). To vključuje transkutane električne živčne STIMULATORJE (TENS) in električne mišične STIMULATORJE (EMS).
OPOMBA Mišični STIMULATOR se lahko imenuje tudi nevromišični STIMULATOR.
Izključena je naslednja ELEKTROMEDICINSKA OPREMA:
– ELEKTROMEDICINSKA OPREMA, namenjena vsaditvi ali priključitvi na vsajene elektrode;
– ELEKTROMEDICINSKA OPREMA, namenjena za stimulacijo možganov (tj. ELEKTROMEDICINSKA OPREMA za elektrokonvulzivno terapijo);
– ELEKTROMEDICINSKA OPREMA, namenjena nevrološkim raziskavam;
– zunanji srčni spodbujevalniki (glejte standard IEC 60601-2-31);
– ELEKTROMEDICINSKA OPREMA za diagnozo na podlagi povprečnih evociranih potencialov (glejte standard IEC 60601-2-40);
– ELEKTROMEDICINSKA OPREMA, namenjena elektromiografiji (glejte standard IEC 60601-2-40);
– ELEKTROMEDICINSKA OPREMA, namenjena defibrilaciji srca (glejte standard IEC 60601-2-4);

General Information

• Status: Published
• Publication Date: 04-Aug-2015
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Apr-2015
• Due Date: 13-Jun-2015
• Completion Date: 05-Aug-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-10:2015 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Relations

• Replaces: SIST EN 60601-2-10:2002 - Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
• Effective Date: 21-Sep-2010
• Amended By: SIST EN 60601-2-10:2015/A1:2017 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012/A1:2016)
• Effective Date: 10-Mar-2015
• Replaces: SIST EN 60601-2-10:2002/A1:2002 - Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987/A1:2001)
• Effective Date: 28-Jan-2023
• Replaces: SIST EN 60601-2-10:2002 - Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-10:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-10:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLåLYþQLKLQPLãLþQLKVWLPXODWRUMHY,(&
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and
essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012)
Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Stimulation von
Nerven und Muskeln (IEC 60601-2-10:2012)
Appareils électromédicaux - Partie 2-10: Exigences particulières pour la sécurité de base
et les performances essentielles des stimulateurs de nerfs et de muscles (IEC 60601-2-
10:2012)
Ta slovenski standard je istoveten z: EN 60601-2-10:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-10:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-10:2015

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SIST EN 60601-2-10:2015


EUROPEAN STANDARD EN 60601-2-10

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.60 Supersedes EN 60601-2-10:2000
English Version
Medical electrical equipment - Part 2-10: Particular requirements
for the basic safety and essential performance of nerve and
muscle stimulators
(IEC 60601-2-10:2012)
Appareils électromédicaux - Partie 2-10: Exigences Medizinische elektrische Geräte - Teil 2-10: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des stimulateurs de nerfs et de muscles wesentlichen Leistungsmerkmale von Geräten zur
(IEC 60601-2-10:2012) Stimulation von Nerven und Muskeln
(IEC 60601-2-10:2012)
This European Standard was approved by CENELEC on 2012-07-09. 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 60601-2-10:2015 E

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SIST EN 60601-2-10:2015
EN 60601-2-10:2015 (E)

Foreword
The text of document 62D/1003/FDIS, future edition 2 of IEC 60601-2-10, prepared by IEC/SC 62 D
"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 60601-2-10:2015.

The following dates are fixed:
• latest date by which the document has (dop) 2015-11-22
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-22
• latest date by which the national
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-10:2000.
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 see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 60601-2-10:2012 was approved by CENELEC as a
European Standard without any modification.
2

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SIST EN 60601-2-10:2015
EN 60601-2-10:2015 (E)


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 with the following exceptions:
Publication Year Title EN/HD Year
Addition:
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
  +corrigendum Mar 2010
  +AC 2014
  +A11 2011
+A1 2012  +A1 2013
  +A12 2014
Replacement:
IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: EN 60601-1-2 2007
(mod) General requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
  +corrigendum Mar. 2010

3

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SIST EN 60601-2-10:2015
EN 60601-2-10:2015 (E)
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.

4

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SIST EN 60601-2-10:2015



IEC 60601-2-10

®


Edition 2.0 2012-06




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical electrical equipment –

Part 2-10: Particular requirements for the basic safety and essential performance

of nerve and muscle stimulators




Appareils électromédicaux –

Partie 2-10: Exigences particulières pour la sécurité de base et les performances


essentielles des stimulateurs de nerfs et de muscles













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX S


ICS 11.040.60 ISBN 978-2-83220-193-0



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-10:2015
– 2 – 60601-2-10  IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions. 8
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents . 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 11
201.11 Protection against excessive temperatures and other HAZARDS . 11
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 11
201.13 HAZARDOUS SITUATIONS and fault conditions . 13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 13
201.15 Construction of ME EQUIPMENT . 13
201.16 ME SYSTEMS . 13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 13
202 Electromagnetic compatibility – Requirements and tests . 14
Annexes . 15
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 16
Annex AA (informative) Particular guidance and rationale . 17
Index of defined terms used in this particular standard. 20

Figure 202.101 – Testing layout . 15

Table 201.101 – Pulse frequency versus applied current limits . 13
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts . 16

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SIST EN 60601-2-10:2015
60601-2-10  IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators


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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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 60601-2-10 has been prepared by IEC subcommittee 62D:
Electromedical equipment of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition, published in 1987 and its
Amendment 1 (2001). This edition constitutes a technical revision and is aligned with
IEC 60601-1:2005+A1:2012.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1003/FDIS 62D/1015/RVD

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.

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SIST EN 60601-2-10:2015
– 4 – 60601-2-10  IEC:2012
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 Annex 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.
The committee has decided that the contents of this publication will remain unchanged until
the stability 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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SIST EN 60601-2-10:2015
60601-2-10  IEC:2012 – 5 –
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of nerve and muscle stimulators.
This particular standard amends and supplements IEC 60601-1 (third edition, 2005 plus
Amendment 1, 2012): Medical electrical equipment – Part 1: General requirements for safety
and essential performance hereinafter referred to as the General Standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.
A "Particular 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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– 6 – 60601-2-10  IEC:2012
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators



201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard specifies the requirements for the safety of nerve and muscle
STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine,
hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve
STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS).
NOTE A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR.
The following ME EQUIPMENT is excluded:
– ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes;
– ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME
EQUIPMENT);
– ME EQUIPMENT intended for neurological research;
– external cardiac pacemakers (see IEC 60601-2-31);
– ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40);
– ME EQUIPMENT intended for electromyography (see IEC 60601-2-40);
– ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for nerve and muscle STIMULATORS as defined in 201.3.204.
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 Clause 201.2 of this particular standard.
IEC 60601-1-2:2007 applies as modified in Clause 202. IEC 60601-1-3 does not apply. All
other published collateral standards in the IEC 60601-1 series apply as published.
—————————
1)
The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance

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SIST EN 60601-2-10:2015
60601-2-10  IEC:2012 – 7 –
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 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 IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 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.
Subclauses, figures or tables 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 with the following exception:
Replacement:

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SIST EN 60601-2-10:2015
– 8 – 60601-2-10  IEC:2012
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 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
201.3 Terms and definitions
Replacement:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012 apply, except as follows:
NOTE 1 Where values of “voltage” and “current” are used in this document, they mean the r.m.s. values of an
alternating, direct or composite voltage or current averaged over 1 s unless stated otherwise.
201.3.8
APPLIED PART
Addition:
STIMULATOR electrodes and all parts conductively connected to them
the
Addition:
201.3.201
LEAD
insulated conductor having a means of connecting to a STIMULATOR at one end and a means
of connecting to an electrode at the other end, and intended for conducting output signals
STIMULATOR to an electrode
from a
201.3.202
PULSE
portion of WAVEFORM between two zero voltage levels
201.3.203
PULSE DURATION
PULSE at 50 % of the maximum amplitude
duration of the output
201.3.204
STIMULATOR
ME EQUIPMENT for the application of electric currents via electrodes in direct contact with the
PATIENT for the diagnosis and/or therapy of neuromuscular disorders.
201.3.205
WAVEFORM
variations in amplitude of an electrical signal which is output from the APPLIED PART (in either
voltage or current) as a function of time .
201.4 General requirements
Clause 4 of the general standard applies, except as follows:

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SIST EN 60601-2-10:2015
60601-2-10  IEC:2012 – 9 –
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Additional subclause:
201.4.1.101 Additional conditions for application to ME EQUIPMENT or ME SYSTEMS
In the case of combined ME EQUIPMENT (e.g. a STIMULATOR provided with a function or an
APPLIED PART for ultrasonic therapy), the additional part shall comply with any relevant
particular standard.
201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Addition:
MANUFACTURERS shall include, within their RISK ANALYSIS, the risk associated with the potential
use of their STIMULATORS and accessories to deliver current exceeding 10 mA or current
2
densities for any electrode exceeding 2 mA/cm .
201.4.11 Power input
Addition:
The EQUIPMENT shall be operated in the output mode and using the load which creates the
highest amplitude steady state current.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Amendment:
Delete TYPE B APPLIED PART.
201.6.6 * Mode of operation
Amendment:
Delete all except CONTINUOUS OPERATION.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.7 Electrical input power from the SUPPLY MAINS
Replacement of the fourth paragraph:

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SIST EN 60601-2-10:2015
– 10 – 60601-2-10  IEC:2012
The RATED input power of a mains powered STIMULATOR shall be the maximum power
averaged over any period of 5 s under the specified operating conditions set out by the
manufacturer.
Additional subclause:
201.7.2.101 * Output
ME EQUIPMENT capable of delivering outputs in excess of 10 mA or 10 V averaged over any
period of 1 s shall be marked near the electrode connections with symbol No. 10 of Table D.2
of the general standard.
201.7.9 Accompanying documents
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 Additional information in instructions for use
The instructions for use shall contain additionally:
a) * Information on the output WAVEFORM(S), including any d.c. component, PULSE DURATIONS,
PULSE repetition frequencies, maximum amplitude of output voltage and/or current, and the
effect of load impedance on these parameters.
b) * Advice on the size and type of electrodes to be used and the method of application for
each particular type of treatment for which the STIMULATOR is intended.
c) Advice on any necessary precautions to be taken when the output contains a d.c.
component.
d) * Advice that a PATIENT with an implanted electronic device (for example a cardiac
pacemaker) should not be subjected to stimulation unless specialist medical opinion has
first been obtained.
e) A warning on the following potential hazards:
– Simultaneous connection of a PATIENT to a high frequency surgical
...