SIST EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

This international standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems. This collateral standard applies to the basic safety and essential performance of me equipment and me systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. basic safety with regard to electromagnetic disturbances is applicable to all me equipment and me systems.

/

Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Perturbation électromagnétique - Exigences et essais

L'IEC 60601-1-2:2014 s'applique à la sécurité de base et aux performances essentielles des appareils Electro Médicaux (EM) et systèmes EM en présence de perturbations électromagnétiques, ainsi qu'aux perturbations électromagnétiques émises par les appareils EM et systèmes EM. La présente norme collatérale à la norme générale IEC 60601-1 a pour objet de spécifier des exigences générales et des essais applicables à la sécurité de base et aux performances essentielles eu égard aux perturbations électromagnétiques et pour les émissions électromagnétiques des appareils EM et des systèmes EM. Ils viennent en complément des exigences de la norme générale IEC 60601-1 et servent de base pour les normes particulières. Cette quatrième édition annule et remplace la troisième édition de l'IEC 60601-1-2, dont elle constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes:  - spécification des niveaux d'essai d'immunité selon les environnements d'utilisation prévue catégorisés selon les emplacements qui sont harmonisés avec l'IEC 60601-1-11: l'environnement d'un établissement de soins de santé professionnel, l'environnement de soins de santé a domicile et les environnements spéciaux;  - spécification des essais et des niveaux d'essai pour améliorer la sécurité des appareils électromédicaux et des systèmes électromédicaux lorsque des appareils de communication portatifs RF sont utilisés plus près des appareils électromédicaux qu'il n'a été recommandé sur la base des niveaux d'essai d'immunité qui ont été spécifiés dans la troisième édition;  - spécification des essais d'immunité et des niveaux d'essai d'immunité selon les accès des appareils électromédicaux ou des systèmes électromédicaux;  - spécification des niveaux d'essai d'immunité basés sur le niveau maximum raisonnablement prévisible des perturbations électromagnétiques dans les environnements d'utilisation prévue, résultant en des niveaux d'essai d'immunité qui sont supérieurs à ceux de l'édition précédente; et  - une meilleure harmonisation avec les concepts de risque de sécurité de base et des performances essentielles incluant la suppression du terme défini 'maintien de la vie'. Cette nouvelle édition inclut les ajouts majeurs suivants:  - lignes directrices pour la détermination des niveaux d'essai d'immunité pour les environnements spéciaux;  - lignes directrices pour l'ajustement des niveaux d'essai d'immunité lorsque des considérations spéciales d'atténuation ou d'utilisation prévue sont applicables;  - lignes directrices relatives à la gestion des risques pour la sécurité de base et les performances essentielles eu égard aux perturbations électromagnétiques; et  - lignes directrices relatives à l'identification des critères d'échec/réussite à l'essai d'immunité.

Medicinska električna oprema - 1-2. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Elektromagnetne motnje - Zahteve in preskušanje

Ta mednarodni standard se uporablja za osnovno varnost in bistvene lastnosti medicinske električne opreme in medicinskih električnih sistemov (v nadaljevanju »elektromedicinska oprema« in »elektromedicinski sistemi«). Ta spremljevalni standard se uporablja za osnovno varnost in bistvene lastnosti elektromedicinske opreme in elektromedicinskih sistemov, izpostavljenih elektromagnetnim motnjam, ter za elektromagnetne motnje, ki jih oddajajo elektromedicinska oprema in elektromedicinski sistemi. Osnovna varnost v zvezi z elektromagnetnimi motnjami se uporablja za vso elektromedicinsko opremo in elektromedicinske sisteme.

General Information

• Status: Published
• Publication Date: 11-Nov-2015
• ICS: 11.040.01 - Medical equipment in general
• ICS: 33.100.01 - Electromagnetic compatibility in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 29-Sep-2015
• Due Date: 04-Dec-2015
• Completion Date: 12-Nov-2015
• Directive: 2004/108/EU - DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: TRRTP129 - Tehnična smernica TSG-12640-001:2008 Zdravstveni objekti
• Ref Project: EN 60601-1-2:2015 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Relations

• Replaces: SIST EN 60601-1-2:2008 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• Effective Date: 29-Jan-2023
• Amended By: SIST EN 60601-1-2:2015/A1:2021 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014/A1:2020)
• Effective Date: 29-Aug-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-2:2015
01-december-2015
1DGRPHãþD
SIST EN 60601-1-2:2008
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHWHKQLþQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG(OHNWURPDJQHWQHPRWQMH
=DKWHYHLQSUHVNXãDQMH
Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic disturbances -
Requirements and tests
/
Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Perturbation électromagnétique -
Exigences et essais
Ta slovenski standard je istoveten z: EN 60601-1-2:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
SIST EN 60601-1-2:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-1-2:2015

---------------------- Page: 2 ----------------------

SIST EN 60601-1-2:2015


EUROPEAN STANDARD EN 60601-1-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2015
ICS 11.040.01; 33.100.10; 33.100.20 Supersedes EN 60601-1-2:2007
English Version
Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
(IEC 60601-1-2:2014)
Appareils électromédicaux - Partie 1-2: Exigences Medizinische elektrische Geräte - Teil 1-2: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: Perturbations wesentlichen Leistungsmerkmale - Ergänzungsnorm:
électromagnétiques - Exigences et essais Elektromagnetische Störgrößen - Anforderungen und
(IEC 60601-1-2:2014) Prüfungen
(IEC 60601-1-2:2014)
This European Standard was approved by CENELEC on 2014-04-01. 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 60601-1-2:2015 E

---------------------- Page: 3 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
European foreword
The text of document 62A/916/FDIS, future edition 4 of IEC 60601-1-2, 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-
2:2015.
The following dates are fixed:
• latest date by which the document has (dop) 2016-03-18
to be implemented at 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 60601-1-2:2007.
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.
Endorsement notice
The text of the International Standard IEC 60601-1-2:2014 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 60601-1-2:2007 NOTE Harmonized as EN 60601-1-2:2007 (not modified)
IEC 60601-2-27:2011 NOTE Harmonized as EN 60601-2-27:2006 (not modified)
IEC 60601-2-44:2009 NOTE Harmonized as EN 60601-2-44:2009 (not modified)
IEC 61000-3-11:2000 NOTE Harmonized as EN 61000-3-11:2000 (not modified)
IEC 61000-3-12:2011 NOTE Harmonized as EN 61000-3-12:2011 (not modified)
IEC 61000-3-12:2011 NOTE Harmonized as EN 61000-3-12:2011 (not modified)
IEC 60601-6-1:2005 NOTE Harmonized as EN 60601-6-1:2007 (not modified)
IEC 60601-6-2:2005 NOTE Harmonized as EN 60601-6-2:2005 (not modified)
IEC 61496-1:2008 NOTE Harmonized as EN 61496-1:2008 (not modified)
CISPR 16-1-1:2010 NOTE Harmonized as EN 55016-1-1:2010 (not modified)
CISPR 16-2-3:2010 NOTE Harmonized as EN 55016-2-3:2010 (not modified)
CISPR 24:2010 NOTE Harmonized as EN 55024:2010 (not modified)
CISPR 25:2008 NOTE Harmonized as EN 55025:2008 (not modified)
ISO 17025:2005 NOTE Harmonized as EN ISO/IEC 17025:2005 (not modified)

2

---------------------- Page: 4 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
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.
However, for any use of this standard “within the meaning of Annex ZZ", the user must always check
that any referenced document has not been superseded and that its relevant contents can still be
considered the generally acknowledged state-of-art.

When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a
normative reference to the parallel EN standard, as outlined below, including the foreword and the
Annexes ZZ.

NOTE 1 The way in which referenced documents are cited in normative requirements determines the extent (in whole or in part)
to which they apply.

NOTE 2  When an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.

Publication Year Title EN/HD and IEC/ISO Year
IEC 60417 Data Graphical symbols for use on equipment IEC 60417 2004
base available from http://www.graphical-
symbols.info/equipment

IEC 60601-1 2005 Medical electrical equipment EN 60601-1 2006
 Part 1: General requirements for basic safety
 and essential performance
A1 2012 A1 2013


IEC 60601-1-8 2006 Medical electrical equipment EN 60601-1-8 2007
 Part 1-8: General requirements for basic + corr. March 2010
 safety and essential performance - Collateral
 standard: General requirements, tests and
 guidance for alarm systems in medical
 electrical equipment and medical electrical
 systems
A1 2013 A1 2013




IEC 60601-1-11 2010 Medical electrical equipment EN 60601-1-11 2010
 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 60601-1-12 2014 Medical electrical equipment
 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 60601-2-2 2010 Medical electrical equipment
 Part 2-2: Particular requirements for the basic
 safety and essential performance of high
3

---------------------- Page: 5 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
Publication Year Title EN/HD and IEC/ISO Year
 frequency surgical equipment and high
 frequency surgical accessories

IEC 60601-2-3 2012 Medical electrical equipment – Part 2-3:
 Particular requirements for the basic safety
 and essential performance of short-wave
 therapy equipment

IEC 61000-3-2 2005 Electromagnetic compatibility (EMC) - Part 3- EN 61000-3-2 2006
 2: Limits - Limits for harmonic current
 emissions (equipment input current <= 16 A
 per phase)
A1 2008 +A1 2009
A2 2009 +A2 2009


IEC 61000-3-3 2013 Electromagnetic compatibility (EMC) - Part 3- EN 61000-3-3 2013
3: Limits - Limitation of voltage changes,
voltage fluctuations and flicker in public low-
voltage supply systems, for equipment with
rated current <= 16 A per phase and not
subject to conditional connection


IEC 61000-4-2 2008 Electromagnetic compatibility (EMC) - Part 4- EN 61000-4-2 2009
2: Testing and measuring techniques -
Electrostatic discharge immunity test


IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - Part 4- EN 61000-4-3 2006
 3: Testing and measurement techniques -
 Radiated, radio-frequency, electromagnetic
 field immunity test
A1 2007 +A1 2008
 +IS1 2009
A2 2010 +A2 2010


IEC 61000-4-4 2012 Electromagnetic compatibility (EMC) - Part 4- EN 61000-4-4 2012
4: Testing and measurement techniques -
Electrical fast transient/burst immunity test


IEC 61000-4-5 2005 Electromagnetic compatibility (EMC) - Part 4- EN 61000-4-5 2006
5: Testing and measurement techniques -
Surge immunity test


IEC 61000-4-6 2013 Electromagnetic compatibility (EMC) - Part 4-
 6: Testing and measurement techniques -
 Immunity to conducted disturbances, induced
 by radio-frequency fields


IEC 61000-4-8 2009 Electromagnetic compatibility (EMC) - Part 4- EN 61000-4-8 2010
8: Testing and measurement techniques -
Power frequency magnetic field immunity test


IEC 61000-4-11 2004 Electromagnetic compatibility (EMC) - Part 4- EN 61000-4-11 2004
11: Testing and measurement techniques -
Voltage dips, short interruptions and voltage
variations immunity tests



CISPR 11 2009 Industrial, scientific and medical equipment - EN 55011 2009

Radio-frequency disturbance characteristics - (mod)

Limits and methods of measurement

A1 2010


CISPR 14-1 2005 Electromagnetic compatibility - Requirements EN 55014-1 2006
for household appliances, electric tools and +A1 2009
similar apparatus - Part 1: Emission +A2 2011



CISPR 16-1-2 2003 Specification for radio disturbance and EN 55016-1-2 2004

immunity measuring apparatus and methods -

Part 1-2: Radio disturbance and immunity
4

---------------------- Page: 6 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
Publication Year Title EN/HD and IEC/ISO Year

measuring apparatus - Ancillary equipment -

Conducted disturbances
A1 2004 +A1 2005
A2 2006 +A2 2006

CISPR 32 2012 Electromagnetic compatibility of multimedia EN 55032 2012
equipment – Emission requirements
ISO 7137 1995 Aircraft – Environmental conditions and test
procedures for airborne equipment
ISO 7637-2 2011 Road vehicles – Electrical disturbances from
conduction and coupling – Part 2: Electrical
transient conduction along supply lines only
ISO 14971 2007 Medical devices – Application of risk EN ISO 14971 2012
management to medical devices


__________
5

---------------------- Page: 7 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
Application of Annexes of the EN 60601 series
The Annex ZZ of EN 60601-1:2006+A1:2013 applies.
6

---------------------- Page: 8 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
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 to provide a means of conforming to the Essential
Requirements given in Annex I of EU Directive 93/42/EEC.
General Guidance:
Once this standard will be cited in the Official Journal of the European Union under that Directive,
compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of that
Directive and associated EFTA regulations.

NOTE 1 The standard’s scope is limited to the specific uses, environments, contexts, objective
situations specifically indicated. It cannot provide for presumption of conformity in other conditions. Some
clauses or subclauses may be not applicable due to the specific type of equipment under consideration.
NOTE 2 Only prescriptions contained in the normative parts of the text are relevant to the
presumption of conformity of this standard. Informative parts may, however, support users to interpret
such prescriptions correctly.
NOTE 3 Where a reference from a clause of this standard to the risk management process
is made, the risk management process needs to be in compliance with Directive 93/42/EEC. This
means that risks have to be reduced "as far as possible", "to a minimum", "to the lowest possible
level", "minimized" or "removed", according to the wording of the corresponding essential
requirement which must be interpreted and applied in such a way as to take account of
technology and practice existing at the time of design and of technical and economical
considerations compatible with a high level of protection of health and safety.
NOTE 4 The manufacturer’s policy for determining acceptable risk must be in compliance
with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.
NOTE 5 For all parts of this standard that a) refer in their clauses to specific national
legislation possibly exempting manufacturers from the thorough application of relevant provisions of this
standard or b) link the completion of a relevant process/prescription to any discretional choice/power of
manufacturers, the user of the standard should check that such clauses are in compliance with Directive
93/42/EEC.
NOTE 6 This Annex ZZ is based on Normative References according to Annex ZA, replacing the
references in the core text.
NOTE 7 According to the scope of this standard the coverage in Table ZZ.1 only applies to
protection of ME equipment and ME systems against electromagnetic disturbances. This European
Standard lists in Table ZZ.1 only the essential requirements covered.
WARNING: Other requirements and other EU Directives and Regulations may be applicable to the
product(s) falling within the scope of this standard.
7

---------------------- Page: 9 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
Table ZZ.1: Relationship between Essential Requirements of Directive 93/42/EEC, and Clauses and
Subclauses of this standard
No. Essential Requirements Coverage EN 60601-1-2
GENERAL REQUIREMENTS
I.
1. General Guidance notes 1-7 shall be observed
1
The devices must be designed and manufactured

in such a way that, when used under the conditions
If the manufacturer follows this
and for the purposes intended, they will not
standard in his design and
compromise the clinical condition or the safety of
manufacturing process, this European
patients, or the safety and health of users or, where
Standard gives a valuable set of
applicable, other persons, provided that any risks
technical requirements to assist in
which may be associated with their intended use
fulfilling this ER with regard to EMC-
constitute acceptable risks when weighed against
aspects of the clinical condition or the
the benefits to the patient and are compatible with
safety of patients, or the safety and
a high level of protection of health and safety.
health of users or, where applicable,
This shall include:
other persons (refer to clauses 4 to 9
of this collateral standard) without
covering the risk benefit balancing.



Covered in respect to
- reducing, as far as possible, the risk of use
7.1 Protection of radio services and
error due to the ergonomic features of the
device and the environment in which the device
other equipment, 7.2 Protection of the
is intended to be used (design for patient
public mains network, and
safety), and
8.9 Immunity test levels
2. General Guidance notes 1-7 shall be observed
st
1 paragraph:
2 The solutions adopted by the manufacturer for the
Covered under the condition that 2nd
design and construction of the devices must
paragraph (including the following 3
conform to safety principles, taking account of the
bullets) is taken into account.
generally acknowledged state of the art.


nd
2 paragraph (including the following 3
In selecting the most appropriate solutions, the
bullets): Not covered.
manufacturer must apply the following principles in
the following order:

- eliminate or reduce risks as far as possible
(inherently safe design and construction),

- where appropriate take adequate protection
measures including alarms if necessary, in
relation to risks that cannot be eliminated,

- inform users of the residual risks due to any
shortcomings of the protection measures
adopted.
REQUIREMENTS FOR DESIGN AND CONSTRUCTION
II.
General Guidance notes 1-7 shall be observed
Devices must be designed and manufactured in
9.2
such a way as to remove or minimize as far as is
8

---------------------- Page: 10 ----------------------

SIST EN 60601-1-2:2015
EN 60601-1-2:2015
No. Essential Requirements Coverage EN 60601-1-2
possible:

- the risk of injury, in connection with their
physical features, including the
volume/pressure ratio, dimensional and where
appropriate ergonomic features;
Covered in respect to electromagnetic
- risks connected with reasonably foreseeable

disturbances, see 8.9 Immunity test
environmental conditions, such as magnetic
fields, external electrical influences,
levels.
electrostatic discharge, pressure, temperature
or variations in pressure and acceleration;
Covered in respect to electromagnetic
- the risks of reciprocal interference with other

disturbances, see 7.1 Protection of radio
devices normally used in the investigations or
for the treatment given;
services and other equipment, 7.2
Protection of the public mains network.

- risks arising where maintenance or calibration
are not possible (as with implants), from ageing
of materials used or loss of accuracy of any
measuring or control mechanism.
11 Protection against radiation General Guidance note 1-7 shall be
observed
11.1 General
11.1.1 Devices shall be designed and manufactured in Covered in respect to electromagnetic
such a way that exposure of patients, users and disturbances, see 7.1 Protection of radio
other persons to radiation shall be reduced as far services and other equipment.
as possible compatible with the intended purpose,
whilst not restricting the application of appropriate
specified levels for therapeutic and diagnostic
purposes.
12 Requirements for medical devices connected to General Guidance notes 1-7 shall be
or equipped with an energy source observed
12.5 Devices must be designed and manufactured in Covered in respect to electromagnetic
such a way as to minimize the risks of creating disturbances, see 7.1 Protection of radio
electromagnetic fields which could impair the services and other equipment.
operation of other devices or equipment in the
usual environment.
13 Information supplied by the manufacturer General Guidance notes 1-7 shall be
observed
13.5 Wherever reasonable and practicable, the devices Covered in respect to aspects related to
and detachable components must be identified, accessories, components and
where appropriate in terms of batches, to allow all subassemblies contained in 5.2.1.1 d)
appropriate action to detect any potential risk and e)
posed by the devices and detachable components.

__________

9

---------------------- Page: 11 ----------------------

SIST EN 60601-1-2:2015

---------------------- Page: 12 ----------------------

SIST EN 60601-1-2:2015




IEC 60601-1-2

®


Edition 4.0 2014-02




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Medical electrical equipment –

Part 1-2: General requirements for basic safety and essential performance –

Collateral Standard: Electromagnetic disturbances – Requirements and tests




Appareils électromédicaux –

Partie 1-2: Exigences générales pour la sécurité de base et les performances


essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences

et essais












INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX XD


ICS 11.040.01, 33.100.10, 33.100.20 ISBN 978-2-8322-1413-8



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.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

---------------------- Page: 13 ----------------------

SIST EN 60601-1-2:2015
– 2 – 60601-1-2 © IEC:2014
CONTENTS
CONTENTS . 2
FOREWORD . 6
INTRODUCTION . 9
1 Scope, object and related standards . 11
1.1 * Scope . 11
1.2 Object . 11
1.3 Related standards . 11
1.3.1 IEC 60601-1 . 11
1.3.2 Particular standards . 11
2 Normative references . 11
3 Terms and definitions . 13
4 General requirements . 17
4.1 RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS . 17
4.2 * Non-ME EQUIPMENT used in an ME SYSTEM . 17
4.3 General test conditions . 17
4.3.1 * Configurations . 17
4.3.2 Artificial hand. 18
4.3.3 * Power input voltages and frequencies . 18
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents . 20
5.1 Additional requirements for marking on the outside of ME EQUIPMENT and
ME SYSTEMS that are specified for use only in a shielded location SPECIAL
ENVIRONMENT . 20
5.2 ACCOMPANYING DOCUMENTS . 20
5.2.1 Instructions for use . 20
5.2.2 Technical description . 21
6 Documentation of the tests . 23
6.1 General . 23
6.2 Test plan . 23
6.3 Test report . 23
7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS . 23
7.1 Protection of radio services and other equipment . 23
7.1.1 * General . 23
7.1.2 Operating modes . 23
7.1.3 Multimedia equipment . 24
7.1.4 * Subsystems . 24
7.1.5 ME EQUIPMENT and ME SYSTEMS specified for use only in a
shielded location SPECIAL ENVIRONMENT . 24
7.1.6 ME EQUIPMENT and ME SYSTEMS that include radio equipment . 24
7.1.7 * ME EQUIPMENT whose main functions are performed by
motors and switching or regulating devices . 25
7.1.8 ME EQUIPMENT and ME SYSTEMS containing X-ray generators . 25
7.1.9 PATIENT physiological simulation . 25
7.1.10 Artificial hand. 25
7.1.11 PATIENT-coupled cables . 25
7.1.12 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE
ME SYSTEMS . 25
7.2 Protection of the PUBLIC MAINS NETWORK . 26

---------------------- Page: 14 ----------------------

SIST EN 60601-1-2:2015
60601-1-2 © IEC:2014 – 3 –
7.2.1 * Harmonic distortion . 26
7.2.2 * Voltage fluctuations and flicker . 26
7.3 EMISSIONS requirements summary . 26
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS . 27
8.1 * General . 27
8.2 PATIENT physiological simulation . 30
8.3 Termination of PATIENT-COUPLED parts . 30
8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD . 30
8.5 * Subsystems . 31
8.6 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS . 31
8.7 * Operating modes . 31
8.8 * Non-ME EQUIPMENT . 32
8.9 * IMMUNITY TEST LEVELS . 32
8.10 * IMMUNITY to proximity fields from RF wireless communications
equipment . 39
9 * Test report . 41
Annex A (informative) General guidance and rationale . 43
A.1 Safety and performance . 43
A.2 Testing of normally non-observable functions. 43
A.3 Rationale for particular clauses and subclauses . 43
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 57
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 57
B.2 ACCOMPANYING DOCUMENTS, instructions for use . 57
B.3 ACCOMPANYING DOCUMENTS, technical description .
...