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

Overview

EN 60601-1-2:2015 (adoption of IEC 60601-1-2:2014) is the fourth‑edition collateral standard that specifies electromagnetic compatibility (EMC) requirements and tests for medical electrical (ME) equipment and ME systems. It defines how devices must behave in the presence of electromagnetic disturbances and how they may emit disturbances, complementing the general medical safety standard IEC 60601‑1. This edition replaces the 3rd edition and introduces technical revisions to immunity testing, emissions, and risk‑based guidance for medical devices used in different environments.

Key Topics and Requirements

• Scope and Purpose
  • Requirements for basic safety and essential performance in the presence of electromagnetic disturbances.
  • Requirements for electromagnetic emissions from ME equipment/systems.
• Environment-based Immunity Test Levels
  • Immunity test levels specified according to intended‑use environments that align with IEC 60601‑1‑11: the professional healthcare facility, home healthcare, and special environments.
  • Some immunity levels are increased to reflect reasonably foreseeable maximum disturbance levels.
• Ports and Proximity Considerations
  • Immunity tests and levels are specified according to device ports (e.g., power, data, patient connections).
  • New test guidance when portable RF communications equipment is used closer to medical equipment than previous editions assumed.
• Risk Management Integration
  • Better harmonization with risk concepts for basic safety and essential performance (including deletion of the term “life‑supporting”).
  • Guidance on applying risk management (e.g., ISO 14971) to EMC-related hazards and on establishing pass/fail criteria for immunity tests.
• Guidance for Special Environments
  • Procedures for determining and adjusting immunity test levels when special environmental mitigations or uses apply.

Practical Applications & Who Uses It

• Medical device manufacturers - to design and validate ME equipment for EMC compliance and safety.
• EMC test laboratories - to perform standardized immunity and emissions testing for regulatory submissions.
• Regulatory and compliance teams - to demonstrate conformity with EU directives and national standards for medical devices.
• Clinical engineers and risk managers - to assess device performance in intended use environments (hospitals, homes, ambulances, etc.).
• R&D teams - to apply EMC requirements early in product development to avoid costly rework.

Related Standards

• IEC 60601‑1 (general medical electrical safety)
• IEC 60601‑1‑11 (home healthcare requirements)
• IEC 61000 series (EMC testing methods, e.g., 4‑2, 4‑3, 4‑6)
• CISPR (emissions measurement standards)
• ISO 14971 (medical device risk management)

For implementation details, testing procedures and exact test levels consult the full SIST EN 60601‑1‑2:2015 / IEC 60601‑1‑2:2014 text.

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 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.
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
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
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.

__________
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

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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

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 . 57
Annex C (informative) Guidance in classification according to CISPR 11 . 59
C.1 General . 59
C.2 Separation into groups . 59
C.3 Division into classes . 60
Annex D (informative) Guidance in the application of IEC 60601-1-2 to particular
standards . 61
D.1 General . 61
D.2 Recommended modifications . 61
D.2.1 Testing requirements . 61
D.2.2 ACCOMPANYING DOCUMENTS . 61
D.3 Cautions . 61
Annex E (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL
ENVIRONMENTS . 63
E.1 General . 63
E.2 Summary of method for E.1 a) . 66
E.3 Summary of method for E.1 b), c) and d) . 66
E.4 Determination of EM DISTURBANCE level reduction . 66
E.5 Assessment of EM DISTURBANCE sources . 66
E.6 Reasonably foreseeable maximum EM DISTURBANCE levels . 67
E.7 Determination of IMMUNITY TEST LEVELS . 67
E.8 RF radiators in SPECIAL ENVIRONMENTS . 67
E.9 Examples of mitigations and special conditions . 68
Annex F (informative) RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE
with regard to ELECTROMAGNETIC DISTURBANCES . 69

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F.1 General . 69
F.2 General requirements for RISK MANAGEMENT . 70
F.3 RISK ANALYSIS . 71
F.4 RISK EVALUATION . 74
F.5 RISK CONTROL . 75
F.5.1 RISK CONTROL option analysis . 75
F.5.2 Implementation of RISK CONTROL measure(s). 75
F.5.3 RESIDUAL RISK EVALUATION . 75
F.5.4 RISK/benefit analysis . 76
F.5.5 RISKS arising from RISK CONTROL measures . 76
F.5.6 Completeness of RISK CONTROL . 76
F.6 Evaluation of overall RESIDUAL RISK acceptability . 76
F.7 RISK MANAGEMENT report . 76
F.8 Production and post-production information . 77
Annex G (informative) Guidance: Test plan . 78
G.1 Test plan contents . 78
Annex H (informative) PATIENT-coupled cables EMISSIONS . 80
H.1 * Protection of other equipment from PATIENT cable conducted EMISSIONS . 80
H.2 Test method . 80
H.3 Rationale . 80
Annex I (informative) Identification of IMMUNITY pass/fail criteria . 82
I.1 General . 82
I.2 IMMUNITY pass/fail criteria principles . 82
I.2.1 General . 82
I.2.2 IMMUNITY pass/fail criteria for non-ME EQUIPMENT used in an
ME SYSTEM . 82
I.2.3 IMMUNITY pass/fail criteria determination . 82
I.3 IMMUNITY pass/fail criteria examples . 83
I.3.1 General examples . 83
I.3.2 Example of IMMUNITY pass/fail criteria for a radiological table
system . 84
Bibliography . 86
Index of defined terms used in this collateral standard . 89

Figure 1 – RC element of the artificial hand . 18
Figure 2 – PORTS of ME EQUIPMENT and ME SYSTEMS . 27
Figure 3 – Examples of environments of INTENDED USE . 33
Figure A.1 – Examples of PORTS (from IEC 61000-6-1:2005) . 47
Figure A.2 – IEC 61000-4-2 Figure A.1 – Maximum values of electrostatic voltages to
which OPERATORS can be charged while in contact with the materials mentioned in A.2 . 54
Figure E.1 – Test plan development flow when SPECIAL ENVIRONMENTS are known . 64
Figure E.2 – Sub-process for determination of IMMUNITY TEST LEVELS for SPECIAL
ENVIRONMENTS . 65
Figure F.1 – Function of this collateral standard in the RISK MANAGEMENT PROCESS . 69
Figure F.2 – Examples of multiple VERIFICATION methods for improving confidence in
RISK levels . 70
Figure H.1 – Setup for PATIENT-COUPLED cables conducted EMISSIONS test for
ME EQUIPMENT and ME SYSTEMS that conform to IEC 60601-2-27 . 81

60601-1-2 © IEC:2014 – 5 –
Table 1 – Power input voltages and frequencies during the tests (1 of 2) . 19
Table 2 – EMISSION limits per environment . 26
Table 3 – Procedure for continuing to test ME EQUIPMENT or ME SYSTEMS that are
damaged by an IMMUNITY test signal . 28
Table 4 – * ENCLOSURE PORT . 34
Table 5 – * Input a.c. power PORT (1 of 2) . 35
Table 6 – Input d.c. power PORT . 37
Table 7 – * PATIENT coupling PORT . 38
Table 8 – Signal input/output parts PORT . 39
Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment . 40
Table 10 – * Minimum test report contents (1 of 2) . 41
Table A.1 – IEC/TR 61000-2-5 information considered in specifying IMMUNITY TEST
LEVELS for each IMMUNITY TEST . 49
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 57
Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use . 57
Table B.3 – ACCOMPANYING DOCUMENTS, technical description . 58
Table E.1 – Examples of specific mitigations / environmental conditions . 68
Table F.1 – Examples of EM phenomena that should be considered in a RISK ANALYSIS . 72
Table G.1 – Recommended minimum test plan contents (1 of 2) . 78
Table H.1 – PATIENT-COUPLED conducted EMISSIONS recommended limit. 80
Table I.1 – Example of IMMUNITY pass criteria for a radiological table system . 85

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-2: General requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests

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
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6) All users should ensure that they have the latest edition of this publication.
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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 60601-1-2 has been prepared by IEC subcommittee 62A: Common
aspects of electrical equipment used in medical practice of IEC technical committee 62:
Electrical equipment in medical practice.
This fourth edition cancels and replaces the third edition of IEC 60601-1-2, published in 2007,
and constitutes a technical revision.
This fourth edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for safety and essential performance hereafter
referred to as the general standard.
The most significant changes with respect to the previous edition include the following
modifications:
60601-1-2 © IEC:2014 – 7 –
– 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 lev
...