SIST EN 60601-1-11:2015

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

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.

Medicinska električna oprema - 1-11. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za medicinsko električno opremo in medicinske električne sisteme, ki se uporabljajo v okolju domače zdravstvene oskrbe

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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SLOVENSKI STANDARD
01-september-2015
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SIST EN 60601-1-11:2010
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DPHGLFLQVNRHOHNWULþQR
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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
Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an medizinische elektrische Geräte und medizinische elektrische Systeme für die
medizinische Versorgung in häuslicher Umgebung
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
Ta slovenski standard je istoveten z: EN 60601-1-11:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD EN 60601-1-11

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040 Supersedes EN 60601-1-11:2010
English Version
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
(IEC 60601-1-11:2015)
Appareils électromédicaux - Partie 1-11: Exigences Medizinische elektrische Geräte - Teil 1-11: Besondere
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme Collatérale: Exigences pour les wesentlichen Leistungsmerkmale - Ergänzungsnorm:
appareils électromédicaux et les systèmes électromédicaux Anforderungen an medizinische elektrische Geräte und
utilisés dans l'environnement des soins à domicile medizinische elektrische Systeme für die medizinische
(IEC 60601-1-11:2015) Versorgung in häuslicher Umgebung
(IEC 60601-1-11:2015)
This European Standard was approved by CENELEC on 2015-04-14. 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 60601-1-11:2015 E
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EN 60601-1-11:2015
Foreword
The text of document 62A/959/FDIS, future edition 2 of IEC 60601-1-11, prepared by SC 62A
"Common aspects of electrical equipment used in medical practice", of IEC/TC 62 "Electrical
equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-1-11:2015.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-01-14
national level by publication of an identical national
standard or by endorsement
(dow) 2018-12-31
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-1-11:2010.
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 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-1-11:2015 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60038:2009 NOTE Harmonized as EN 60038:2011 (modified).
IEC 60065:2014 NOTE Harmonized as EN 60065:2014 (modified).
IEC 60335-1:2010 NOTE Harmonized as EN 60335-1:2012 (modified).
IEC 60364 NOTE Harmonized in HD 384 / HD 60364 series (partly modified).
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9.
IEC 60721-3-7:1995 NOTE Harmonized as EN 60721-3-7:1995 (not modified).
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EN 60601-1-11:2015
IEC 60950-1:2005 NOTE Harmonized as EN 60950-1:2006 (modified)
+ A1:2009 + A1:2010 (modified)
+ A2:2013 + A2:2013 (modified).
IEC 61032:1997 NOTE Harmonized as EN 61032:1998 (not modified).
ISO 10651-2:2004 NOTE Harmonized as EN ISO 10651-2:2009 (not modified).

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EN 60601-1-11:2015
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.

Publication Year Title EN/HD Year
IEC 60068-2-27 2008 Environmental testing - EN 60068-2-27 2009
Part 2-27: Tests - Test Ea and guidance:
Shock
IEC 60068-2-31 2008 Environmental testing - EN 60068-2-31 2008
Part 2-31: Tests - Test Ec: Rough handling
shocks, primarily for equipment-type
specimens
IEC 60068-2-64 2008 Environmental testing - EN 60068-2-64 2008
Part 2-64: Tests - Test Fh: Vibration,
broadband random and guidance
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
- -  + corrigendum May 1993
+ A1 1999 + A1 2000
+ A2 2013 + A2 2013
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance
+ A1 2012 + A1 2013
- -  + A1/AC 2014
- -  + A12 2014
IEC 60601-1-2 2014 Medical electrical equipment - EN 60601-1-2 2014
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 - EN 60601-1-6 2010
Part 1-6: General requirements for basic
+ A1 2013 + A1 2015
safety and essential performance -
Collateral standard: Usability
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EN 60601-1-11:2015
Publication Year Title EN/HD Year
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
+ A1 2012 Collateral Standard: General requirements, + A1 2013
tests and guidance for alarm systems in
- -  + A1/AC 2014
medical electrical equipment and medical
electrical systems
IEC 60601-1-12 2014 Medical electrical equipment - EN 60601-1-12 2015
Part 1-12: 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 EN 62366 2008
engineering to medical devices
+ A1 2014 + A1 2015
CISPR 11 (mod) 2009 Industrial, scientific and medical EN 55011 2009
equipment - Radio-frequency disturbance
characteristics - Limits and methods of
measurement
ISO 7000 -  Graphical symbols for use on equipment - - -
Registered symbols
ISO 7010 2011 Graphical symbols - Safety colours and EN ISO 7010 2012
safety signs - Registered safety signs
+ A1 2012 + A1 2014
+ A2 2012 + A2 2014
+ A3 2012 + A3 2014
+ A4 2013 + A4 2014
+ A5 2014 + A5 2015
ISO 15223-1 2012 Medical devices - Symbols to be used with EN ISO 15223-1 2012
medical device labels, labelling and
information to be supplied -
Part 1: General requirements
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EN 60601-1-11:2015
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.
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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

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– 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

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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

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Table B.4 – ACCOMPANYING DOCUMENTS, technical description . 53
Table C.1 – General symbols . 54

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IEC 60601-1-11:2015 © IEC 2015 – 5 –
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.

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– 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;
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– “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.
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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.

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IEC 60601-1-11:2015 © IEC 2015 – 9 –
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.
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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).

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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 o
...