SIST EN 60601-1-11:2015

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
SLOVENSKI STANDARD
SIST EN 60601-1-11:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-1-11:2010
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DPHGLFLQVNRHOHNWULþQR
RSUHPRLQPHGLFLQVNHHOHNWULþQHVLVWHPHNLVHXSRUDEOMDMRYRNROMXGRPDþH
]GUDYVWYHQHRVNUEH
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
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

---------------------- Page: 2 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
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).
2

---------------------- Page: 4 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
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).

3

---------------------- Page: 5 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
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
4

---------------------- Page: 6 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
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

5

---------------------- Page: 7 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
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.
6

---------------------- Page: 8 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10




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
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
– 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

---------------------- Page: 10 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
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

---------------------- Page: 11 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
– 4 – IEC 60601-1-11:2015 © IEC 2015
Table B.4 – ACCOMPANYING DOCUMENTS, technical description . 53
Table C.1 – General symbols . 54

---------------------- Page: 12 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
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.

---------------------- Page: 13 ----------------------
SIST EN 60601-1-11:2015
Posebna objava SIS
...