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

NEW! IEC 60601-1-11:2015 is available as IEC Standards+ 60601-1-11:2015 which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-1-11:201 5 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical 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 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.

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

NEW! IEC 60601-1-11:2015 est disponible sous forme de IEC Standards+ 60601-1-11:2015 qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente. L'IEC 60601-1-11:2015 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, destinés à être utilisés dans l'environnement des soins à domicile. Elle s'applique sans distinguer si l'appareil électromédical ou le système électromédical est prévu pour être utilisé par un opérateur non spécialiste ou par du personnel de santé qualifié. L'environnement des soins à domicile comprend:
- l'habitation dans laquelle un patient vit; - d'autres environnements où des patients sont présents à l'intérieur comme à l'extérieur, à l'exclusion des environnements des établissements de soins où des opérateurs ayant une formation médicale sont disponibles de façon continue lorsque des patients sont présents. Cette deuxième édition annule et remplace la première édition de l'IEC 60601-1-11, parue en 2010. Cette édition constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes: - correction de la méthode d'essai pour le contrôle de l'humidité relative à des températures supérieures à 35 °C; - reformulation des paragraphes qui modifient plus qu'ils ne complètent la norme générale ou d'autres normes collatérales; et - harmonisation avec les modifications apportées aux amendements de la norme générale et aux autres normes collatérales.

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

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV za uporabo v OKOLJU
DOMAČE ZDRAVSTVENE OSKRBE, kot je določeno v poglavju 3.1 in kot je navedel PROIZVAJALEC v navodilih za uporabo. Ta mednarodni standard velja ne glede na to, ali je ELEKTROMEDICINSKA OPREMA ali ELEKTROMEDICINSKI SISTEM namenjen uporabi nestrokovnjakov ali usposobljenega osebja za zdravstveno oskrbo.
OKOLJE DOMAČE ZDRAVSTVENE OSKRBE vključuje:
– stanovanje, v katerem PACIENT prebiva;
– drugi zunanji in notranji prostori, kjer so PACIENTI prisotni, razen okolja strokovnih zdravstvenih ustanov, kjer so IZVAJALCI z medicinskim znanjem neprestano na voljo, ko so PACIENTI prisotni.
Ta mednarodni standard se ne uporablja za ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME, namenjene izključno za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI, ki so zajeti v standardu IEC 60601-1-12, ali namenjene izključno za uporabo v strokovnih zdravstvenih ustanovah, ki so zajeti v standardu IEC 60601-1 brez dodatkov standarda IEC 60601-1-12 ali tega spremljevalnega standarda. Kljub temu so ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICISNKI SISTEMI lahko namenjeni uporabi v različnih okoljih in so tako v področju uporabe tega standarda tudi, če so med drugim namenjeni za uporabo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE. PRIMER: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI namenjeni tako za uporabo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE in okolju strokovnih zdravstvenih ustanov.
OPOMBA: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI, namenjeni uporabi v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE, se lahko pogosto uporabljajo na mestih z nezanesljivimi električnimi viri in slabo ozemljitvijo.

General Information

Status
Published
Publication Date
21-May-2015
Current Stage
6060 - Document made available
Due Date
22-May-2015
Completion Date
22-May-2015

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SLOVENSKI STANDARD
SIST EN 60601-1-11:2015
01-september-2015
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SIST EN 60601-1-11:2010
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DPHGLFLQVNRHOHNWULþQR
RSUHPRLQPHGLFLQVNHHOHNWULþQHVLVWHPHNLVHXSRUDEOMDMRYRNROMXGRPDþH
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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
SIST EN 60601-1-11:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-1-11:2015
---------------------- Page: 2 ----------------------
SIST EN 60601-1-11:2015
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
---------------------- Page: 3 ----------------------
SIST EN 60601-1-11:2015
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).
---------------------- Page: 4 ----------------------
SIST EN 60601-1-11:2015
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).
---------------------- Page: 5 ----------------------
SIST EN 60601-1-11:2015
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
---------------------- Page: 6 ----------------------
SIST EN 60601-1-11:2015
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
---------------------- Page: 7 ----------------------
SIST EN 60601-1-11:2015
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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SIST EN 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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-2180-8

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

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

---------------------- Page: 9 ----------------------
SIST EN 60601-1-11:2015
– 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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SIST EN 60601-1-11:2015
IEC 60601-1-11:2015 © IEC 2015 – 3 –

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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SIST EN 60601-1-11:2015
– 4 – IEC 60601-1-11:2015 © IEC 2015

Table B.4 – ACCOMPANYING DOCUMENTS, technical description ............................................... 53

Table C.1 – General symbols ................................................................................................ 54

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SIST EN 60601-1-11:2015
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,

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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

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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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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 f
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