IEC 60601-1-11:2010

IEC 60601-1-11
Edition 1.0 2010-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

IEC 60601-1-11:2010

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IEC 60601-1-11
Edition 1.0 2010-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040 ISBN 978-2-88910-920-3

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– 2 – 60601-1-11 © IEC:2010
CONTENTS

FOREWORD.4
INTRODUCTION.7
1 Scope, object and related standards.8
1.1 * Scope .8
1.2 Object .8
1.3 Related standards .8
1.3.1 IEC 60601-1 .8
1.3.2 Particular standards .8
2 Normative references .9
3 Terms and definitions .9
4 General requirements .11
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS.11
4.2 Environmental conditions for ME EQUIPMENT.11
4.2.1 * Environmental conditions of transport and storage between uses.11
4.2.2 * Environmental operating conditions.12
4.2.3 * Environmental shock to TRANSIT-OPERABLE ME EQUIPMENT.13
5 * General requirements for testing ME EQUIPMENT .14
6 * Classification of ME EQUIPMENT and ME SYSTEMS.15
7 ME EQUIPMENT identification, marking and documents.15
7.1 * USABILITY of the ACCOMPANYING DOCUMENTS .15
7.2 * Additional requirements for marking of IP classification.16
7.3 ACCOMPANYING DOCUMENTS.16
7.3.1 Contact information .16
7.3.2 LAY OPERATOR briefing information.16
7.4 Instructions for use.17
7.4.1 Additional requirements for warning and safety notices.17
7.4.2 * Additional requirements for an electrical power source .17
7.4.3 Additional requirements for ME EQUIPMENT description .18
7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE .18
7.4.5 Additional requirements for operating instructions.18
7.4.6 Additional requirements for ME EQUIPMENT messages.18
7.4.7 * Additional requirements for cleaning, disinfection and sterilization .19
7.4.8 Additional requirements for maintenance .19
7.4.9 Additional requirements for environmental protection.19
7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS.20
7.5 Technical description.20
7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT .20
7.5.2 Additional requirements for professional hygienic maintenance .20
8 Protection against excessive temperatures and other HAZARDS .20
8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and
ME SYSTEMS .20
8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS .20
8.3 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS .21
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT.21

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60601-1-11 © IEC:2010 – 3 –
8.3.2 * Ingress of water or particulate matter into ME SYSTEMS .21
8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT and ME SYSTEM.21
9 Accuracy of controls and instruments and protection against hazardous outputs .22
10 Construction of ME EQUIPMENT .22
10.1 * Additional requirements for mechanical strength .22
10.1.1 General requirements for mechanical strength.22
10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE
ME EQUIPMENT .24
10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE
ME EQUIPMENT .25
10.2 * Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE .26
10.3 Additional requirements for actuating parts of controls of ME EQUIPMENT .27
11 * Protection against strangulation or asphyxiation.27
12 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS .27
12.1 Emissions classification.28
12.2 Protection of the PUBLIC MAINS NETWORK .28
12.3 * Additional technical description requirements applicable to ME EQUIPMENT
and ME SYSTEMS .28
12.4 * Additional requirements applicable to ME EQUIPMENT and ME SYSTEMS
specified for use only in a shielded location.28
12.5 * Additional requirements for ELECTROSTATIC DISCHARGE (ESD) tests.28
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS .28
13.1 * Additional requirement for generation of ALARM SIGNALS .28
13.2 * Additional requirement for ALARM SIGNAL volume .29
Annex A (informative) General guidance and rationale.30
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS .49
Annex C (informative) Symbols on marking.53
Bibliography.54
Index of defined terms used in this collateral standard.56

Figure 1 – Small finger probe ∅ 5,6 .15

Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE .23
Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE .24
Table A.1 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
ENCLOSURE ingress of water and particulate matter requirements.42
Table A.2 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
subjected to shock and vibration .43
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts .49
Table B.2 – ACCOMPANYING DOCUMENTS, general.49
Table B.3 – ACCOMPANYING DOCUMENTS, instructions for use .51
Table B.4 – ACCOMPANYING DOCUMENTS, instructions for use (continued).52
Table B.5 – ACCOMPANYING DOCUMENTS, technical description.52
Table C 1 – General symbols.53

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– 4 – 60601-1-11 © IEC:2010
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 first edition constitutes a collateral standard to IEC 60601-1:2005 (third edition): Medical
electrical equipment – Part 1: General requirements for basic safety and essential
performance hereafter referred to as the general standard.

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60601-1-11 © IEC:2010 – 5 –
The text of this collateral standard is based on the following documents of IEC:
FDIS Report on voting
62A/693/FDIS 62A/696/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 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 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 7.2.1 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 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.

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The committee has decided that the contents of this amendment and the base 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 implementation nationally not earlier than 3 years from the date of publication.
The contents of the corrigendum of April 2011 have been included in this copy.

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60601-1-11 © IEC:2010 – 7 –
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 3.2). 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.

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– 8 – 60601-1-11 © IEC:2010
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, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS, which are intended by their MANUFACTURER for use in the
HOME HEALTHCARE ENVIRONMENT, as defined in 3.2, regardless of whether the ME EQUIPMENT or
ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.
NOTE 1 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can also be intended for use in other
environments, for example, in a professional healthcare facility.
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely
for use by emergency medical services or solely for use in professional healthcare facilities.
NOTE 2 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.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.

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60601-1-11 © IEC:2010 – 9 –
2 Normative references
The following referenced documents are indispensable for the application of this document.
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 54.
IEC 60068-2-27:2008, Environmental testing – Part 2-27: Tests – 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)

1)
Amendment 1 (1999)
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
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
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral Standard: Usability
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
CISPR 11:2009, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics - Limits and methods of measurement
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-1-8:2006 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 56.
—————————
1)
There ex
...