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
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
08-Apr-2015
Due Date
13-Jun-2015
Completion Date
05-Aug-2015

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SLOVENSKI STANDARD
SIST EN 60601-2-10:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-10:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
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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.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-10:2015
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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.
---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
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.
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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.
---------------------- Page: 9 ----------------------
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.
---------------------- Page: 10 ----------------------
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.
---------------------- Page: 11 ----------------------
SIST EN 60601-2-10:2015
– 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
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.

—————————

The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance
---------------------- Page: 12 ----------------------
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:
---------------------- Page: 13 ----------------------
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:
---------------------- Page: 14 ----------------------
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

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
...

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