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

IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments; - specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition; - specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system; - specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and - better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term 'life-supporting'. This new edition includes the following main additions: - guidance for determination of immunity test levels for special environments; - guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable; - guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and - guidance on identification of immunity pass/fail criteria.

Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Elektromagnetische Störgrößen - Anforderungen und Prüfungen

Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Perturbations électromagnétiques - 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: 17-Sep-2015
• Withdrawal Date: 30-Dec-2018
• ICS: 11.040.01 - Medical equipment in general
• ICS: 33.100.10 - Emission
• ICS: 33.100.20 - Immunity
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 18-Sep-2015
• Completion Date: 18-Sep-2015
• Directive: 2004/108/EC - 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: 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: 2014/30/EU - Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: 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

Relations

• Replaces: EN 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• Effective Date: 29-Jan-2023
• Amended By: 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
• Effective Date: 29-Aug-2017

Standards Content (Sample)

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

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
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)

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
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
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
__________
Application of Annexes of the EN 60601 series
The Annex ZZ of EN 60601-1:2006+A1:2013 applies.
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
...