IEC 60601-1-11:2015

IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment

Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the

latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,

77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient plus de 30 000 termes et définitions en
Spécifications techniques, Rapports techniques et autres
anglais et en français, ainsi que les termes équivalents dans
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
15 langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.

Recherche de publications IEC - www.iec.ch/searchpub
Glossaire IEC - std.iec.ch/glossary
Plus de 60 000 entrées terminologiques électrotechniques, en
La recherche avancée permet de trouver des publications IEC
en utilisant différents critères (numéro de référence, texte, anglais et en français, extraites des articles Termes et
comité d’études,…). Elle donne aussi des informations sur les Définitions des publications IEC parues depuis 2002. Plus
projets et les publications remplacées ou retirées. certaines entrées antérieures extraites des publications des

CE 37, 77, 86 et CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished

Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just
Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
csc@iec.ch.
IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 1-11: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems used in the home healthcare environment

Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances

essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux

et les systèmes électromédicaux utilisés dans l’environnement des soins à

domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-2180-8

– 2 – IEC 60601-1-11:2015 © IEC 2015
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 12
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and
ME SYSTEMS . 12
4.2 * Environmental conditions for ME EQUIPMENT . 12
4.2.1 General . 12
4.2.2 * Environmental conditions of transport and storage between uses . 13
4.2.3 * Environmental operating conditions . 14
5 * General requirements for testing ME EQUIPMENT . 16
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 17
7 ME EQUIPMENT identification, marking and documents . 17
7.1 * USABILITY of the ACCOMPANYING DOCUMENTS . 17
7.2 * Additional requirements for marking of IP classification . 18
7.3 ACCOMPANYING DOCUMENTS . 18
7.3.1 Contact information . 18
7.3.2 LAY OPERATOR briefing information . 18
7.4 Instructions for use . 19
7.4.1 Additional requirements for warning and safety notices . 19
7.4.2 * Additional requirements for an electrical power source . 19
7.4.3 Additional requirements for ME EQUIPMENT description . 20
7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 20
7.4.5 Additional requirements for operating instructions . 20
7.4.6 Additional requirements for ME EQUIPMENT messages . 21
7.4.7 * Additional requirements for cleaning, disinfection and sterilization . 21
7.4.8 Additional requirements for maintenance . 21
7.4.9 Additional requirements for environmental protection . 21
7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS . 22
7.5 Technical description . 22
7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT . 22
7.5.2 Additional requirements for professional hygienic maintenance . 22
8 Protection against excessive temperatures and other HAZARDS . 22
8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and
ME SYSTEMS . 22
8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS. 23
8.3 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 23
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT . 23

8.3.2 * Ingress of water or particulate matter into ME SYSTEMS . 23
8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT and ME SYSTEM . 23
8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE . 24
8.5.1 * Indication of state . 24
8.5.2 Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs . 25
9 Accuracy of controls and instruments and protection against hazardous outputs . 25
10 Construction of ME EQUIPMENT . 25
10.1 * Additional requirements for mechanical strength . 25
10.1.1 General requirements for mechanical strength . 25
10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE
ME EQUIPMENT . 27
10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE
ME EQUIPMENT . 28
10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT . 29
11 * Protection against strangulation or asphyxiation . 30
12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and
ME SYSTEMS . 30
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS . 30
13.1 * Additional requirement for generation of ALARM SIGNALS . 30
13.2 * Additional requirement for ALARM SIGNAL volume . 30
Annex A (informative) General guidance and rationale . 31
A.1 General guidance . 31
A.2 Rationale for particular clauses and subclauses . 32
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 51
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 51
B.2 ACCOMPANYING DOCUMENTS, general . 51
B.3 ACCOMPANYING DOCUMENTS, instructions for use . 51
B.4 ACCOMPANYING DOCUMENTS, technical description . 53
Annex C (informative) Symbols on marking . 54
Bibliography . 56
Index of defined terms used in this collateral standard . 58

Figure 1 – Small finger probe Ø 5,6 . 17
Figure A.1 – Saturation water vapour pressure as function of temperature . 36

Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE . 26
Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE . 27
Table A.1 – Saturation water vapour pressure as function of temperature . 37
Table A.2 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
ENCLOSURE ingress of water and particulate matter requirements . 46
Table A.3 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
subjected to shock and vibration . 47
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 51
Table B.2 – ACCOMPANYING DOCUMENTS, general . 51
Table B.3 – ACCOMPANYING DOCUMENTS, instructions for use . 52

– 4 – IEC 60601-1-11:2015 © IEC 2015
Table B.4 – ACCOMPANYING DOCUMENTS, technical description . 53
Table C.1 – General symbols . 54

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used
in the home healthcare environment

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 60601-1-11 has been prepared by a joint working group of
IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice of
IEC technical committee 62: Electrical equipment in medical practice and ISO subcommittee
SC3: Lung ventilators and related devices, of ISO technical committee 121: Anaesthetic and
respiratory equipment.
It is published as a double logo standard.
This second edition constitutes a collateral standard to IEC 60601-1 (third edition, including
Amendment 1): Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance, hereafter referred to as the general standard.

– 6 – IEC 60601-1-11:2015 © IEC 2015
This second edition cancels and replaces the first edition of IEC 60601-1-11, published in
2010, and constitutes a technical revision.
The most significant changes with respect to the previous edition include the following
modifications:
– correction of test method for relative humidity control at temperatures above 35 °C;
– redrafting of subclauses that altered instead of adding to the general standard or other
collateral standards; and
– harmonizing with the changes to the amendments to the general standard and other
collateral standards.
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/959/FDIS 62A/978/RVD
Full information on the voting for the approval of this collateral standard can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved by
17 P-members out of 17 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In the IEC 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. ALARM SYSTEMS).
In this collateral 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 COLLATERAL STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this collateral standard, the term
– “clause” means one of the 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 7.3.1 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 collateral 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.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A
are marked with an asterisk (*).
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.
NOTE The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations may need a transitional period following publication of a new, amended or
revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this
publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of
publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 8 – IEC 60601-1-11:2015 © IEC 2015
INTRODUCTION
Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS for monitoring, treatment or diagnosis of PATIENTS in the HOME HEALTHCARE
ENVIRONMENT (see 3.1). The safety of MEDICAL ELECTRICAL EQUIPMENT in this uncontrolled
environment with regard to the electrical installation and its related safety and protection
means is a cause for concern.
The potential lack of training of the LAY OPERATOR and possibly of those supervising the use of
the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM and their level of education
need to be addressed in the development of the ACCOMPANYING DOCUMENTS and in the
relevant marking on the equipment itself so that this material can be understood. This
collateral standard gives special guidance on how this should be addressed in the instructions
for use.
This collateral standard was developed with contributions from clinicians, engineers and
regulators. The terminology, requirements, general recommendations and guidance of this
collateral standard are intended to be useful for MANUFACTURERS of MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for the
development of particular standards.

MEDICAL ELECTRICAL EQUIPMENT –

Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used
in the home healthcare environment

1 Scope, object and related standards
1.1 * Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME
HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the
instructions for use. This International Standard applies regardless of whether the
ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare
personnel.
The HOME HEALTHCARE ENVIRONMENT includes:
– the dwelling place in which a PATIENT lives;
– other places where PATIENTS are present both indoors and outdoors, excluding
professional healthcare facility environments where OPERATORS with medical training are
continually available when PATIENTS are present.
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely
for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or
solely for use in professional healthcare facilities covered by IEC 60601-1 without the
additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or
ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for
use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.
EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the
professional healthcare facility environment.
NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with
unreliable electrical sources and poor electrical grounding.
1.2 Object
The object of this collateral standard is to specify general requirements that are in addition to
those of the general standard and to serve as the basis for particular standards.
1.3 Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1.
When referring to IEC 60601-1 or to this collateral standard, either individually or in
combination, the following conventions are used:
– "the general standard" designates IEC 60601-1 alone;
– "this collateral standard" designates IEC 60601-1-11 alone;
– "this standard" designates the combination of the general standard and this collateral
standard.
– 10 – IEC 60601-1-11:2015 © IEC 2015
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.
2 Normative references
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 The way in which these referenced documents are cited in normative requirements determines the extent
(in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography on page 56.
CISPR 11:2009, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics – Limits and methods of measurement
IEC 60068-2-27:2008, Environmental testing – Part 2-27: Tests – Test Ea and guidance:
Shock
IEC 60068-2-31:2008, Environmental testing – Part 2-31: Tests – Test Ec: Rough handling
shocks, primarily for equipment-type specimens
IEC 60068-2-64:2008, Environmental testing Part 2-64: Tests – Test Fh: Vibration, broadband
random and guidance
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
1)
IEC 60529:1989/AMD2:2013
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance

2)
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability

3)
IEC 60601-1-6:2010/AMD1:2013)
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems

4)
IEC 60601-1-8:2006/AMD1:2012
___________
1)
There exists a consolidated edition 2.2 (2013) including IEC 60529:1989 and its Amendment 1 (1999) and
Amendment 2 (2013).
2)
There exists a consolidated edition 3.1(2012) including IEC 60601-1:2005 and its Amendment 1 (2012).
3)
There exists a consolidated edition 3.1 (2013) including IEC 60601-1-6:2010 and its Amendment 1 (2013).
4)
There exists a consolidated edition 2.1 (2012) including IEC 60601-1-8:2006 and its Amendment 1 (2012).

IEC 60601-1-12:2014, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the emergency
medical services environment
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices

5)
IEC 62366:2007/AMD1:2014
ISO 7000, Graphical symbols for use on equipment — Registered symbols. Available from:
http://www.graphical-symbols.info/equipment
ISO 7010:2011, Graphical symbols – Safety colours and safety signs – Registered safety
signs
ISO 7010:2011/AMD1:2012
ISO 7010:2011/AMD2:2012
ISO 7010:2011/AMD3:2012
ISO 7010:2011/AMD4:2013
ISO 7010:2011/AMD5:2014
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005:AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010 and
IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012,
IEC 60601-1-12:2014, IEC 62366:2007 and the following definitions apply.
NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of an
alternating, direct or composite voltage or current unless stated otherwise.
NOTE 2 The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. This
standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in
the context of an ME SYSTEM.
NOTE 3 An index of defined terms used in this collateral standard is found beginning on page 58.
3.1
HOME HEALTHCARE ENVIRONMENT
dwelling place in which a PATIENT lives or other places where PATIENTS are present, excluding
professional healthcare facility environments where OPERATORS with medical training are
continually available when PATIENTS are present
EXAMPLES In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.
Note 1 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical
centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms,
multiple treatment facilities and emergency medical services.
Note 2 to entry: For the purpose of this collateral standard, nursing homes are considered HOME HEALTHCARE
ENVIRONMENTS.
Note 3 to entry: Other places where a PATIENT is present include the outdoor environment, while working and in
vehicles.
___________
5)
There exists a consolidated edition 2.1 (2014) including IEC 62366:2007 and Amendment 1 (2014).

– 12 – IEC 60601-1-11:2015 © IEC 2015
3.2
* LAY
term referring to non-professional or professional without relevant specialized training
EXAMPLES LAY OPERATOR, LAY RESPONSIBLE ORGANIZATION.
3.3
SHELF LIFE
maximum period of time that an item can be stored prior to its first use under the conditions
described in its labelling and remain suitable for use
3.4
TRANSIT-OPERABLE
term referring to TRANSPORTABLE equipment whose INTENDED USE includes operation
while it is being moved
EXAMPLES TRANSPORTABLE ME EQUIPMENT that is BODY-WORN, HAND-HELD, attached to a wheelchair, or used in a
car, bus, train, boat or plane.
Note 1 to entry: For the purpose of this standard, TRANSIT-OPERABLE use in the HOME HEALTHCARE ENVIRONMENT
can include use indoors, outdoors and in vehicles.
4 General requirements
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
For ME EQUIPMENT or ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT, the
characteristics of the SUPPLY MAINS specified in 4.10.2 of the general standard apply, with the
following additions.
SUPPLY MAINS in the HOME HEALTHCARE ENVIRONMENT shall be assumed to have the following
characteristics: no voltage in excess of 110 % or lower than 85 % of the NOMINAL voltage
between any of the conductors of the system or between any of these conductors and earth.
For ME EQUIPMENT or ME SYSTEMS intended to actively keep alive or resuscitate a PATIENT,
SUPPLY MAINS in the HOME HEALTHCARE ENVIRONMENT shall be assumed to have the following
NOMINAL voltage
characteristics: no voltage in excess of 110 % or lower than 80 % of the
between any of the conductors of the system or between any of these conductors and earth.
The RATED range of NOMINAL voltage of the ME EQUIPMENT in the HOME HEALTHCARE
ENVIRONMENT shall include at least 12,4 V to 15,1 V for operation from 12 V d.c. SUPPLY MAINS
and at least 24,8 V to 30,3 V for operation from 24 V d.c. SUPPLY MAINS.
ME EQUIPMENT and ME SYSTEMS in the HOME HEALTHCARE ENVIRONMENT shall maintain BASIC
and ESSENTIAL PERFORMANCE during and following a 30 s dip to 10 V from a 12 V d.c.
SAFETY
SUPPLY MAINS and during and following a 30 s dip to 20 V for operation from a 24 V d.c.
SUPPLY MAINS.
4.2 * Environmental conditions for ME EQUIPMENT
4.2.1 General
All environmental tests at temperatures below +5 °C need not be performed with humidity
control of the test chamber.
NOTE In IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, the MANUFACTURER specifies the permissible
conditions of use, including conditions for transport and storage in the technical description (see 7.9.3.1, second
dash). These conditions are referenced in requirements for testing throughout the general standard, (e.g. 5.3 and
11.1.1).
4.2.2 * Environmental conditions of transport and storage between uses
The instructions for use shall indicate the permissible environmental conditions of transport
and storage of ME EQUIPMENT after the ME EQUIPMENT has been removed from its protective
packaging and subsequently between uses.
Unless otherwise indicated in the instructions for use or if the ME EQUIPMENT is STATIONARY,
the ME EQUIPMENT shall remain operational in NORMAL USE within its specification and the
requirements of this standard after transport or storage in the following environmental range:
– – 25 °C to + 5 °C, and
– + 5 °C to + 35 °C at a relative humidity up to 90 %, non-condensing;
– > 35 °C to 70 °C at a water vapour pressure up to 50 hPa
after having been removed from its protective packaging and subsequently between uses.
6)
NOTE 1 This represents class 7K3 as described in IEC TR 60721-4-7:2001 [7] .
If the instructions for use state a more restricted range of environmental transport and storage
conditions between uses, these environmental conditions shall be:
– justified in the RISK MANAGEMENT FILE;
– marked on the ME EQUIPMENT, unless such marking is not practicable, in which case the
more restricted range need only be disclosed in the instructions for use; and
– marked on the carrying case, if the instructions for use indicate that the ME EQUIPMENT is
intended to be transported or stored in a carrying case between uses.
Symbols 5.3.5 (ISO 7000-0534 (2004-01)), 5.3.6 (ISO 7000-0533 (2004-01)) or 5.3.7
(ISO 7000-0632 (2004-01)) of ISO 15223-1:2012 may be used to mark the temperature range
(see Table C.1, symbols 2, 3 and 4). Symbol 5.3.8 (ISO 7000-2620) of ISO 15223-1:2012 may
be used to mark the humidity range (see Table C.1, symbol 5) and symbol 5.3.9 (ISO 7000-
2621) of ISO 15223-1:2012 may be used to mark the atmospheric pressure range (see
Table C.1, symbol 6). Where ME EQUIPMENT has different markings for conditions of transport
and storage between uses, continuous operating conditions (see 4.2.3.1) and transient
operating conditions (see 4.2.3.2), those markings shall be accompanied by supplementary
marking (e.g. appropriate wording) except where the respective applicability would be obvious
(e.g. limits for transport and storage between uses on the carrying case and limits for
operation on the ME EQUIPMENT itself).
Compliance is checked by the following test and, when a more restricted range is stated in the
instructions for use, inspection of the RISK MANAGEMENT FILE.
a) Prepare the ME EQUIPMENT for transport or storage according to instructions for use.
EXAMPLES Removal of batteries, emptying fluid reservoirs.
b) Expose the ME EQUIPMENT to its lowest specified environmental transport and storage
conditions (temperature °C):
−4
– for at least 16 h; or
– confirm that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
c) Then expose the ME EQUIPMENT to 34 °C ± 4 °C and 90 % – 0 % + 6 % relative humidity
until the test chamber reaches equilibrium. The transition from low to high temperature
conditions should be made slowly enough to provide a non-condensing environment. Hold
for at least 2 h.
___________
6)
Figures in square brackets refer to the Bibliography.

– 14 – IEC 60601-1-11:2015 © IEC 2015
d) Then expose the ME EQUIPMENT to its highest specified environmental transport and
storage conditions, but not requiring a water vapour partial pressure greater than 50 hPa,
+4
(temperature °C):
– for at least 16 h; or
– confirm that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
NOTE 2 The intent of specifying a minimum duration of the exposure to both the low and high temperature
conditions is to ensure that the entire ME EQUIPMENT reaches the stated conditions.
e) At the end of this conditioning period, allow the ME EQUIPMENT to return and stabilize at the
operating conditions of NORMAL USE.
f) Evaluate the ME EQUIPMENT to its specifications and confirm that it provides BASIC SAFETY
and ESSENTIAL PERFORMANCE.
4.2.3 * Environmental operating conditions
4.2.3.1 Continuous operating conditions
The instructions for use shall indicate the permissible environmental operating conditions of
the ME EQUIPMENT.
NOTE 1 The environmental operating conditions should be marked on TRANSIT-OPERABLE ME EQUIPMENT, unless
such marking is not practicable, in which case the environmental operating conditions need only be disclosed in the
instructions for use.
Unless otherwise indicated in the instructions for use, the ME EQUIPMENT shall comply with its
specifications and all the requirements of this standard when operated in NORMAL USE under
the following environmental operating conditions:
– a temperature range of + 5 °C to + 40 °C;
– a relative humidity range of 15 % to 90 %, non-condensing, but not requiring a water
vapour partial pressure greater than 50 hPa; and
– an atmospheric pressure range of 700 hPa to 1 060 hPa.
NOTE 2 This represents class 7K1 as described in IEC TR 60721-4-7:2001 [7].
If the instructions for use state a more restricted range of environmental operating conditions,
these conditions shall be:
– justified in the RISK MANAGEMENT FILE;
– marked on the ME EQUIPMENT, unless such marking is not practicable, in which case the
more restricted range need only be disclosed in the instructions for use; and
– marked on the carrying case if the instructions for use indicate that the ME EQUIPMENT is
intended to be operated in a carrying case.
Symbols 5.3.5 (ISO 7000-0534 (2004-01)), 5.3.6 (ISO 7000-0533 (2004-01)) or 5.3.7
(ISO 7000-0632 (2004-01)) of ISO 15223-1:2012 may be used to mark the temperature range
(see Table C.1, symbols 2, 3 and 4). Symbol 5.3.8 (ISO 7000-2620 (2004-01)) of
ISO 15223-1:20
...