EN 60601-1:2006/A1:2013

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

The contents of the corrigendum of July 2014 have been included in this copy.

Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale

Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles

Le contenu du corrigendum de juillet 2014 a été pris en considération dans cet exemplaire.

Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Dopolnilo A1

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTRIČNE MEDICINSKE OPREME in ELEKTRIČNIH MEDICINSKIH SISTEMOV, v nadaljevanju ME OPREMA in ME SISTEMI. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla.Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME opreme in ME SISTEMOV v okviru področja uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1. Ta standard se lahko uporablja tudi za opremo, ki se uporablja za kompenziranje ali lajšanje bolezni, poškodbe ali prizadetosti. Diagnostična oprema in vitro, ki ni zajeta z definicijo ME OPREME, je zajeta s serijo 2 IEC 61010. Ta standard ne velja za vsadne dele aktivnih medicinskih vsadkov, ki so zajeti v ISO 14708-1. Ta EN 60601-1:2006 je bil v primerjavi z EN 60601-1:1990 precej preurejen. Zahteve v električnem delu so bile nadalje usklajene s tistimi za opremo informacijske opreme, ki jih zajema EN 60950-1, dodana je bila tudi zahteva za vključitev PROCESA ZA OBVLADOVANJE TVEGANJ. Za razširjen opis te revizije glej točko A.3.

General Information

• Status: Published
• Publication Date: 03-Oct-2013
• Withdrawal Date: 23-Dec-2018
• ICS: 11.040 - Medical equipment
• 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: 04-Oct-2013
• Completion Date: 04-Oct-2013
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• 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
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-1:2007/A1:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Relations

• Replaces: EN 60601-1:2006/A11:2011 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023
• Amends: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023
• Corrected By: EN 60601-1:2006/A1:2013/AC:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 23-Jan-2023

Overview

EN 60601-1:2006/A1:2013 (equivalent to IEC 60601-1:2005/A1:2012) is the European/CENELEC amendment for medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This edition incorporates amendment A1 (approved 2013-09-24) and includes the corrigendum of July 2014 in the copy. The standard provides a harmonized framework to demonstrate safety and essential performance of a broad range of medical electrical devices and supports conformity with EU medical device rules.

Key topics

• Basic safety and essential performance: overarching requirements to ensure devices operate safely and perform as intended under normal and single-fault conditions.
• Risk management linkage: refers to and requires application of a risk management process (see ISO 14971) to reduce risks to acceptable levels.
• Electrical and insulation principles: general requirements for protection against electric shock, insulation coordination and leakage current controls (normative references provided).
• Collateral and particular standards: integration with related IEC/EN collateral parts such as EMC (IEC 60601-1-2), usability (IEC 60601-1-6), radiation protection, alarm systems (IEC 60601-1-8) and others.
• Normative references and testing: extensive list of referenced standards (electrical, mechanical, environmental, battery safety, sterilization, acoustic and more) that are indispensable for application of EN 60601-1/A1.
• Regulatory alignment: Annex ZZ maps requirements to the Essential Requirements of Directive 93/42/EEC (MDD) as amended, offering a presumption of conformity when applied correctly.

Applications

• Medical device manufacturers use EN 60601-1/A1 to design, verify and document safety and essential performance for electrically powered medical devices (e.g., diagnostic, therapeutic, monitoring equipment).
• Regulatory and compliance teams rely on the standard to demonstrate conformity with EU directives and for CE marking evidence.
• Test laboratories and notified bodies use the standard and its normative references for type testing, certification and conformity assessment.
• Design engineers and risk managers reference the standard to integrate electrical safety, usability and risk reduction into product lifecycle processes.

Who should use it

• Medical device manufacturers and OEMs
• Regulatory affairs and quality managers (CE marking, MDD/EU requirements)
• Testing and certification bodies
• Design engineers, risk management specialists, and clinical safety officers

Related standards (examples)

• IEC/EN 60601-1-2 (EMC), IEC/EN 60601-1-6 (Usability), IEC/EN 60601-1-8 (Alarms), ISO 14971 (Risk management), ISO 10993 (Biocompatibility).

Keywords: EN 60601-1:2006/A1:2013, IEC 60601-1, medical electrical equipment standard, basic safety, essential performance, EU medical device directive, risk management, EMC, usability.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2014
1DGRPHãþD
SIST EN 60601-1:2007/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL'RSROQLOR$
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles
Ta slovenski standard je istoveten z: EN 60601-1:2006/A1:2013
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1/A1
NORME EUROPÉENNE
October 2013
EUROPÄISCHE NORM
ICS 11.040
English version
Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance
(IEC 60601-1:2005/A1:2012)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1: Exigences générales pour la Teil 1: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles Leistungsmerkmale
(CEI 60601-1:2005/A1:2012) (IEC 60601-1:2005/A1:2012)

This amendment A1 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on
2013-09-24. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment 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 amendment 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.

CENELEC
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

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1:2006/A1:2013 E

Foreword
The text of document 62A/805/FDIS, future IEC 60601-1:2005/A1, 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
The following dates are fixed:
• latest date by which the document has
(dop) 2014-06-24
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national
(dow) 2018-12-24
standards conflicting with the
document have to be withdrawn
In the foreword of EN 60601-1:2006, replace the first sentence of the third paragraph by:
This European Standard supersedes EN 60601-1:1990 and its amendments, EN 60601-1-1:2001 and
EN 60601-1-4:1996 + A1:1999.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 60601-1:2005/A1:2012 was approved by CENELEC as a
European Standard without any modification.
Replace the Bibliography of EN 60601-1:2006 by:
IEC 60073 NOTE Harmonized as EN 60073.
IEC 60086-1 NOTE Harmonized as EN 60086-1.
IEC 60127-6 NOTE Harmonized as EN 60127-6.
IEC 60309-1 NOTE Harmonized as EN 60309-1.
IEC 60332-1-2 NOTE Harmonized as EN 60332-1-2.
IEC 60332-2-2 NOTE Harmonized as EN 60332-2-2.
IEC 60317-43 NOTE Harmonized as EN 60317-43.
IEC 60601-1-1:2000 NOTE Harmonized as EN 60601-1-1:2001 (not modified).
IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996 + A1:1999 (not modified).
IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.
IEC 60601-2-22 NOTE Harmonized as EN 60601-2-22.
IEC 60601-2-49:2001 NOTE Harmonized as EN 60601-2-49:2001 (not modified).

- 3 - EN 60601-1:2006/A1:2013
IEC 60695-1-10 NOTE Harmonized as EN 60695-1-10.
IEC 60721 series NOTE Harmonized in EN 60721 series.
IEC 60990 NOTE Harmonized as EN 60990.
IEC 61000-4-11 NOTE Harmonized as EN 61000-4-11.
IEC 61010 series NOTE Harmonized in EN 61010 series.
IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010 (not modified).
IEC 61140:2001 NOTE Harmonized as EN 61140:2002 (not modified).
IEC 61558-1 NOTE Harmonized as EN 61558-1.
IEC 61558-2-4 NOTE Harmonized as EN 61558-2-4.
IEC 61558-2-23 NOTE Harmonized as EN 61558-2-23.
IEC 62079:2001 NOTE Harmonized as EN 62079:2001 (not modified).
IEC 62353 NOTE Harmonized as EN 62353.
IEC 62471:2006 NOTE Harmonized as EN 62471:2008 (modified).
IEC 80001-1:2010 NOTE Harmonized as EN 80001-1:2011 (not modified).
ISO 407 NOTE Harmonized as EN ISO 13407.
ISO 7396-1 NOTE Harmonized as EN ISO 7396-1.
ISO 8041 NOTE Harmonized as EN ISO 8041.
ISO 13485 NOTE Harmonized as EN ISO 13485.
ISO 15001 NOTE Harmonized as EN ISO 15001.

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Replace Annex ZA of EN 60601-1:2006 by :
Publication Year Title EN/HD Year

IEC 60065 (mod) 2001 Audio, video and similar electronic apparatus EN 60065 2002
+ corr. August 2002 - Safety requirements + corr. August 2007
+ A1 (mod) 2005 + A1 2006
+ A2 (mod) 2010 + A2 2010
+ A11 2008
+ A12 2011
IEC 60068-2-2 2007 Environmental testing - EN 60068-2-2 2007
Part 2-2: Tests - Test B: Dry heat

IEC 60079-0 - Explosive atmospheres - EN 60079-0 -
Part 0: Equipment - General requirements

IEC 60079-2 - Explosive atmospheres - EN 60079-2 -
Part 2: Equipment protection by pressurized
enclosure "p"
IEC 60079-5 - Explosive atmospheres - EN 60079-5 -
Part 5: Equipment protection by powder
filling "q"
IEC 60079-6 - Explosive atmospheres - EN 60079-6 2007
Part 6: Equipment protection by oil
immersion "o"
IEC 60083 - Plugs and socket-outlets for domestic and - -
similar general use standardized in member
countries of IEC
IEC 60085 - Electrical insulation - Thermal evaluation and EN 60085 -
designation
IEC 60086-4 - Primary batteries - EN 60086-4 -
Part 4: Safety of lithium batteries

IEC 60112 - Method for the determination of the proof EN 60112 -
and the comparative tracking indices of solid
insulating materials
IEC 60127-1 - Miniature fuses - EN 60127-1 -
Part 1: Definitions for miniature fuses and
general requirements for miniature fuse-links

IEC 60227-1 2007 Polyvinyl chloride insulated cables of rated - -
voltages up to and including 450/750 V -
Part 1: General requirements
IEC 60245-1 2003 Rubber insulated cables - Rated voltages up - -
+ A1 2007 to and including 450/750 V -
Part 1: General requirements
- 5 - EN 60601-1:2006/A1:2013
Publication Year Title EN/HD Year
IEC 60252-1 - AC motor capacitors - EN 60252-1 -
Part 1: General - Performance, testing and
rating - Safety requirements - Guidance for
installation and operation
IEC 60320-1 - Appliance couplers for household and similar EN 60320-1 -
general purposes -
Part 1: General requirements
IEC 60335-1 (mod) 2010 Household and similar electrical appliances - EN 60335-1 2012
+ corr. July 2010 Safety -
+ corr. April 2011 Part 1: General requirements

IEC 60364-4-41 - Low-voltage electrical installations - HD 60364-4-41 -
Part 4-41: Protection for safety - Protection
against electric shock
1)
IEC 60384-14 2005 Fixed capacitors for use in electronic EN 60384-14 2005
equipment -
Part 14: Sectional specification - Fixed
capacitors for electromagnetic interference
suppression and connection to the supply
mains
IEC 60417 Graphical symbols for use on equipment - -
Data-
base
IEC 60445 - Basic and safety principles for man-machine EN 60445 -
interface, marking and identification -
Identification of equipment terminals,
conductor terminations and conductors

IEC 60447 - Basic and safety principles for man-machine EN 60447 -
interface, marking and identification -
Actuating principles
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
+ A1 1999 enclosures (IP Code) + corr. May 1993
+ A1 2000
IEC 60601-1-2 - Medical electrical equipment - EN 60601-1-2 -
Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-3 - Medical electrical equipment - EN 60601-1-3 -
Part 1-3: General requirements for basic
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
IEC 60601-1-6 - Medical electrical equipment - EN 60601-1-6 -
Part 1-6: General requirements for basic
safety and essential performance - Collateral
standard: Usability
1)
EN 60384-14 is superseded by EN 60384-14:2013, which is based on IEC 60384-14:2013.

Publication Year Title EN/HD Year
IEC 60601-1-8 - Medical electrical equipment - EN 60601-1-8 -
Part 1-8: General requirements for basic
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
IEC 60664-1 2007 Insulation coordination for equipment within EN 60664-1 2007
low-voltage systems -
Part 1: Principles, requirements and tests

IEC 60695-11-10 - Fire hazard testing - EN 60695-11-10 -
Part 11-10: Test flames - 50 W horizontal
and vertical flame test methods

IEC 60730-1 (mod) 2010 Automatic electrical controls for household EN 60730-1 2011
and similar use -
Part 1: General requirements
IEC 60825-1 2007 Safety of laser products - EN 60825-1 2007
Part 1: Equipment classification and
requirements
IEC 60851-3 2009 Winding wires - Test methods - EN 60851-3 2009
Part 3: Mechanical properties
IEC 60851-5 2008 Winding wires - Test methods - EN 60851-5 2008
Part 5: Electrical properties
2)
IEC 60851-6 1996 Winding wires - Test methods - EN 60851-6 1996

+ A1 1997 Part 6: Thermal properties + A1 1997

IEC 60884-1 - Plugs and socket-outlets for household and - -
similar purposes -
Part 1: General requirements
3)
IEC 60950-1 (mod) 2001 Information technology equipment - Safety - EN 60950-1 2001
+ corr. October 2002 Part 1: General requirements + corr. December 2007

+ A11 2004
4)
IEC 61058-1 (mod) 2000 Switches for appliances - EN 61058-1 2002

+ corr. January 2009 Part 1: General requirements + A2 2008
+ A1 2001
+ A2 2007
IEC 61558-2-1 - Safety of power transformers, power EN 61558-2-1 -
supplies, reactors and similar products -
Part 2-1: Particular requirements and tests
for separating transformers and power
supplies incorporating separating
transformers for general applications

IEC 61672-1 - Electroacoustics - Sound level meters - EN 61672-1 -
Part 1: Specifications
IEC 61672-2 - Electroacoustics - Sound level meters - EN 61672-2 -
Part 2: Pattern evaluation tests

IEC 61965 - Mechanical safety of cathode ray tubes EN 61965 -

2)
EN 60851-6 is superseded by EN 60851-6:2012, which is based on IEC 60851-6:2012.
3)
EN 60950-1 is superseded by EN 60950-1:2006, which is based on IEC 60950-1:2005.
4)
EN 61058-1 includes A1 to IEC 61058-1 (mod) + corr. January .

- 7 - EN 60601-1:2006/A1:2013
Publication Year Title EN/HD Year
IEC 62133 - Secondary cells and batteries containing EN 62133 -
alkaline or other non-acid electrolytes -
Safety requirements for portable sealed
secondary cells, and for batteries made from
them, for use in portable applications

IEC 62304 2006 Medical device software - Software life-cycle EN 62304 2006
processes + corr. November 2008

ISO 780 - Packaging - Pictorial marking for handling of EN ISO 780 -
goods
ISO 1853 - Conducting and dissipative rubbers, - -
vulcanized or thermoplastic - Measurement
of resistivity
ISO 2878 - Rubber, vulcanized - Antistatic and - -
conductive products - Determination of
electrical resistance
ISO 2882 - Rubber, vulcanized - Antistatic and - -
conductive products for hospital use -
Electrical resistance limits
ISO 3746 - Acoustics - Determination of sound power EN ISO 3746 -
levels and sound energy levels of noise
sources using sound pressure - Survey
method using an enveloping measurement
surface over a reflecting plane

ISO 3864-1 2002 Graphical symbols - Safety colours and - -
safety signs -
Part 1: Design principles for safety signs in
workplaces and public areas
ISO 5349-1 - Mechanical vibration - Measurement and EN ISO 5349-1 -
evaluation of human exposure to hand-
transmitted vibration -
Part 1: General requirements
ISO 7000 2004 Graphical symbols for use on equipment - - -
Index and synopsis
ISO 7010 2011 Graphical symbols - Safety colours and - -
safety signs - Registered safety signs

ISO 9614-1 - Acoustics - Determination of sound power EN ISO 9614-1 -
levels of noise sources using sound intensity
-
Part 1: Measurement at discrete points

ISO 10993 series Biological evaluation of medical devices EN ISO 10993 series

ISO 11135-1 2007 Sterilization of health care products - EN ISO 11135-1 2007
Ethylene oxide -
Part 1: Requirements for development,
validation and routine control of a
sterilization process for medical devices

ISO 11137-1 2006 Sterilization of health care products - EN ISO 11137-1 2006
Radiation -
Part 1: Requirements for development,
validation and routine control of a
sterilization process for medical devices

ISO 13857 2008 Safety of machinery - Safety distances to EN ISO 13857 2008
prevent hazard zones being reached by
upper and lower limbs
Publication Year Title EN/HD Year
ISO 14971 2007 Medical devices - Application of risk EN ISO 14971 2012
management to medical devices
ISO 15223-1 2012 Medical devices - Symbols to be used with EN ISO 15223-1 2012
medical device labels, labelling and
information to be supplied -
Part 1: General requirements
ISO 17665-1 2006 Sterilization of health care products - Moist EN 17665-1 2006
heat -
Part 1: Requirements for the development,
validation and routine control of a
sterilization process for medical devices

ISO 23529 - Rubber - General procedures for preparing - -
and conditioning test pieces for physical test
methods
ISO 80000-1 2009 Quantities and units - EN ISO 80000-1 2013
Part 1: General
- 9 - EN 60601-1:2006/A1:2013
Annex ZZ
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices
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 the EC Directives 93/42/EEC as amended by 2007/47/EC.
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 This standard is intended to be applied in its entirety only. Selected clauses or
subclauses may be not applicable due to the specific type of equipment under consideration. It is
necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply
those clauses which contain general requirements related to a specific subclause. Elements of the
standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain
essential requirements through indirect reference, and for safety and performance aspects of the
device, that are not addressed through essential requirements.
NOTE 2 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 to the MDD (Directive 93/42/EEC
amended by 2007/47/EC). 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.
NOTE 3 With respect to note 4 of clause 4.2.2 General requirement for risk management, 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 4 References in the clauses 3 to 17 or in the Annexes of this standard specify whether
the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.
NOTE 5 This Annex ZZ is based on Normative References according to Annex ZA, replacing
the references in the core text.
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 amended by
2007/47/EC, and Clauses and Subclauses of this standard
No. Essential Requirement Coverage
I.
1. General Guidance note 2 and 3 shall be observed
1 Not completely covered
The devices must be designed and

manufactured in such a way that, when
But If the manufacturer follows this standard in his
used under the conditions and for the
design and manufacturing process, this European
purposes intended, they will not
Standard gives a valuable set of technical
compromise the clinical condition or the
requirements to assist in fulfilling this ER for
safety of patients, or the safety and
equipment in the scope of this standard.
health of users or, where applicable,

other persons, provided that any risks

which may be associated with their
intended use constitute acceptable risks
when weighed against the benefits to
the patient and are compatible with a
high level of protection of health and
safety.
This shall include:
Not covered
- reducing, as far as possible, the risk
See EN/IEC 60601-1-6, EN/IEC 62366,
of use error due to the ergonomic
EN/IEC 60601-1-11 and
features of the device and the
EN/IEC 60601-1-12
environment in which the device is
intended to be used (design for
patient safety), and
- consideration of the technical Covered only for accompanying documents by:
knowledge, experience, education
7.9.1 Paragraphs 4 and 5, intended operator
and training and where applicable
the medical and physical conditions
of intended users (design for lay,
professional, disabled or other
users).
2. General Guidance note 2 and 3 shall be observed
st
1 paragraph:
2 The solutions adopted by the
Covered only in respect of the following and under
manufacturer for the design and
nd
the condition that 2 paragraph (including the
construction of the devices must
following 3 bullets) is taken into account:
conform to safety principles, taking
8 Protection against electrical hazards from ME
account of the generally acknowledged
equipment
state of the art.
9 Protection against mechanical hazards of ME

equipment and ME systems
In selecting the most appropriate
15 Construction of me equipment
solutions, the manufacturer must apply

nd
the following principles in the following
2 paragraph (including the following 3 bullets)
order:
Not covered in the normative text.

- 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

- 11 - EN 60601-1:2006/A1:2013
No. Essential Requirement Coverage
protection measures adopted.
Not covered
3 The devices must achieve the
performances intended by the
manufacturer and be designed,
manufactured and packaged in such a
way that they are suitable for one or
more of the functions referred to in
Article 1 (2) (a), as specified by the
manufacturer.
Not covered
4 The characteristics and performances
However, the standard provides a procedure for the
referred to in Sections 1, 2 and 3 must
generation of information that is necessary to
not be adversely affected to such a
document that the device is in compliance with this
degree that the clinical conditions and
ER.
safety of the patients and, where
applicable, of other persons are
compromised during the lifetime of the
device as indicated by the
manufacturer, when the device is
subjected to the stresses which can
occur during normal conditions of use.
5. General Guidance note 2 and 3 shall be observed
Covered only in respect of the following:
5 The devices must be designed,
Instructions and information provided by the
manufactured and packed in such a
manufacturer
way that their characteristics and
7.2.17 Marking on protective packaging
performances during their intended use
7.9.3.1 Technical description
will not be adversely affected during
15.3.7 Environmental influences
transport and storage taking account of

the instructions and information
provided by the manufacturer.
6. General Guidance note 2 and 3 shall be observed
Not covered.
6 Any undesirable side-effect must

constitute an acceptable risk when
weighed against the performances
intended.
Not covered
6a Demonstration of conformity with the
essential requirements must include a
clinical evaluation in accordance with
Annex X.
II.
Chemical, physical and biological General Guidance note 2 and 3 shall be observed
properties
The devices must be designed and Not covered
7.1
manufactured in such a way as to
guarantee the characteristics and
performances referred to in Section I (3)
on the ‘General requirements’.

Particular attention must be paid to:
- the choice of materials used, Partially covered in respect of the following:
particularly as regards toxicity and,
Toxicity:
where appropriate, flammability,
11.7 Biocompatibility, the manufacturer should apply
the appropriate part of the EN ISO 10993 series
13.1.2 Emissions, deformation of Enclosure or

No. Essential Requirement Coverage
exceeding maximum temperature
Flammability:
11.2 Fire prevention
11.3 Constructional requirements for fire enclosures
11.4 ME equipment and ME systems intended for
use with flammable
anaesthetics
Annex G Protection against hazards of ignition of
flammable anaesthetic
mixtures
Not covered
- the compatibility between the

materials used and biological
The manufacturer should apply the appropriate part
tissues, cells and body fluids, taking
of the EN ISO 10993 series
account of the intended purpose of
the device,
- where appropriate, the results of Not covered

biophysical or modeling research
whose validity has been
demonstrated beforehand.
The devices must be designed, Not covered
7.2
manufactured and packed in such a
way as to minimize the risks posed by
contaminants and residues to the
persons involved in the transport,
storage and use of the devices and to
the patients, taking account of the
intended purpose of the product.
Particular attention must be paid to the
tissues exposed and to the duration and
frequency of exposure.
The devices must be designed and Covered only for the physical properties dealt with in
7.3
manufactured in such a way that they Subclauses:
can be used safely with the materials, 11.2.2 ME equipment and ME systems used in
substances and gases with which they conjunction with oxygen rich environments
enter into contact during their normal 11.2.3 Single fault conditions related to oxygen rich
use or during routine procedures; environments
and 11.6.1, 11.6.2, 11.6.3, 11.6.4, 11.6.6, 11.6.7,
11.6.8 (Overflow, spillage, leakage, cleaning,
disinfection, sterilization and compatibility with
substances used)
if the devices are intended to administer Not covered

medicinal products they must be
designed and manufactured in such a
way as to be compatible with the
medicinal products concerned
according to the provisions and
restrictions governing these products
and that their performance is
maintained in accordance with the
intended use.
Not covered
7.4 Where a device incorporates, as an
integral part, a substance which, if used
separately, may be considered to be a

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No. Essential Requirement Coverage
medicinal product as defined in Article 1
of Directive 2001/83/EC and which is
liable to act upon the body with action
ancillary to that of the device, the
quality, safety and usefulness of the
substance must be verified by analogy
with the methods specified in Annex I to
Directive 2001/83/EC.
Not covered
For the substances referred to in the
first paragraph, the notified body shall,
having verified the usefulness of the
substance as part of the medical device
and taking account of the intended
purpose of the device, seek a scientific
opinion from one of the competent
authorities designated by the Member
States or the European Medicines
Agency (EMEA) acting particularly
through its committee in accordance
with Regulation (EC) No 726/2004 on
the quality and safety of the substance
including the clinical benefit/risk profile
of the incorporation of the substance
into the device. When issuing its
opinion, the competent authority or the
EMEA shall take into account the
manufacturing process and the data
related to the usefulness of
incorporation of the substance into the
device as determined by the notified
body.
Where a device incorporates, as an
integral part, a human blood derivative,
the notified body shall, having verified
the usefulness of the substance as part
of the medical device and taking into
account the intended purpose of the
device, seek a scientific opinion from
the EMEA, acting particularly through its
committee, on the quality and safety of
the substance including the clinical
benefit/risk profile of the incorporation of
the human blood derivative into the
device. When issuing its opinion, the
EMEA shall take into account the
manufacturing process and the data
related to the usefulness of
incorporation of the substance into the
device as determined by the notified
body.
Where changes are made to an
ancillary substance incorporated in a
device, in particular related to its
manufacturing process, the notified
body shall be informed of the changes
and shall consult the relevant medicines
competent authority (i.e. the one
involved in the initial consultation), in

No. Essential Requirement Coverage
order to confirm that the quality and
safety of the ancillary substance are
maintained. The competent authority
shall take into account the data related
to the usefulness of incorporation of the
substance into the device as
determined by the notified body, in
order to ensure that the changes have
no negative impact on the established
benefit/risk profile of the addition of the
substance in the medical device.
When the relevant medicines
competent authority (i.e. the one
involved in the initial consultation) has
obtained information on the ancillary
substance, which could have an impact
on the established benefit/risk profile of
the addition of the substance in the
medical device, it shall provide the
notified body with advice, whether this
information has an impact on the
established benefit/risk profile of the
addition of the substance in the medical
device or not. The notified body shall
take the updated scientific opinion into
account in reconsidering its assessment
of the conformity assessment
procedure.
The devices must be designed and Covered in respect of the following:
7.5
manufactured in such a way as to
reduce to a minimum the risks posed by 9.7 Pressure vessels and parts subject to pneumatic
substances leaking from the device. and hydraulic pressure,

11.6.1 Protection against overflow, spillage, leakage,
ingress of water or particulate matter, cleaning,
disinfection and sterilization, compatibility with
substances
11.6.2 Overflow
15.4.9 Oil containers
Special attention shall be given to Not covered

substances which are carcinogenic,
mutagenic or toxic to reproduction, in
accordance with Annex I to Council
Directive 67/548/EEC of 27 June 1967
on the approximation of laws,
regulations and administrative
provisions relating to the classification,
packaging and labeling of dangerous
substances.
If parts of a device (or a device itself) Not covered

intended to administer and/or remove
medicines, body liquids or other
substances to or from the body, or
devices intended for transport and
storage of such body fluids or
substances, contain phthalates which

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No. Essential Requirement Coverage
are classified as carcinogenic,
mutagenic or toxic to reproduction, of
category 1 or 2, in accordance with
Annex I to Directive 67/548/EEC, these
devices must be labeled on the device
itself and/or on the packaging for each
unit or, where appropriate, on the sales
packaging as a device containing
phthalates.
If the intended use of such devices Not covered

includes treatment of children or
treatment of pregnant or nursing
women, the manufacturer must provide
a specific justification for the use of
these substances with regard to
compliance with the essential
requirements, in particular of this
paragraph, within the technical
documentation and, within the
instructions for use, information on
residual risks for these patient groups
and, if applicable, on appropriate
precautionary measures.
Not covered
7.6 Devices must be designed and

manufactured in such a way as to
reduce, as much as possible, risks
posed by the unintentional ingress of
substances into the device taking into
account the device and the nature of
the environment in which it is intended
to be used.
8 Infection and microbial General Guidance note 2 and 3 shall be observed
contamination
Not covered
8.1 The devices and manufacturing

processes must be designed in such a
way as to eliminate or reduce as far as
possible the risk of infection to the
patient, user and third parties. The
design must allow easy handling and,
where necessary, minimize
contamination of the device by the
patient or vice versa during use.
Tissues of animal origin must originate Not covered
8.2
from animals that have been subject to
veterinary controls and surveillance
adapted to the intended use of the
tissues.
Notified Bodies shall retain information Not covered

on the geographical origin of the
animals.
Processing, preservation, testing and Not covered

handling of tissues, cells and
substances of animal origin must be
carried out so as to provide optimal
security. In particular safety with regard
to viruses and other transmissible
agents must be addressed by
No. Essential Requirement Coverage
implementation of validated methods of
elimination or viral inactivation in the
course of the manufacturing process.
Devices delivered in a sterile state must Not covered
8.3
be designed, manufactured and packed
in a non-reusable pack and/or
according to appropriate procedures to
ensure that they are sterile when placed
on the market and remain sterile, under
the storage and transport conditions laid
down, until the protective packaging is
damaged or opened.
Devices delivered in a sterile state must Not covered
8.4
have been manufactured and sterilized
by an appropriate, validated method.
Devices intended to be sterilized must Not covered
8.5
be manufactured in appropriately
controlled (e.g. environmental)
conditions.
Packaging system for non-sterile Covered in respect of
8.6
devices must keep the product without
deterioration at the level of cleanliness 7.2.17 Marking aspects of protective packaging
stipulated and, if the devices are to be
sterilized prior to use, minimize the risk
of microbial contamination;
the packaging system must be suitable Not covered

taking account of the method of
sterilization indicated by the
manufacturer.
The packaging and/or label of the Not covered
8.7
device must distinguish between
identical or similar products sold in both
sterile and non-sterile condition.
9 Construction and environmental General Guidance note 2 and 3 shall be observed
properties
Covered in respect of the following:
9.1 If the device is intended for use in
9.1 Mechanical hazards
combination with other devices or
16.3 Power supply
equipment, the whole combination,
16.5 Separation devices
including the connection system must
16.6 Leakage currents
be safe and must not impair the
16.8 Interruption of power supply
specified performances of the devices.

Covered by 16.2 Accompanying documents of an
Any restrictions on use must be
ME system
indicated on the label or in the
instructions for use.
Devices must be designed and
9.2
manufactured in such a way as to
remove or minimize as far as is
possible:
Covered in respect of the following:
- the risk of injury, in connection with

their physical features, including the
8.1 Electric shock
volume/pressure ratio, dimensional
9.1 Mechanical Hazards
and where appropriate ergonomic
10 Radiation (all types)
features;
11.1 Excessive temperatures
11.2 Fire prevention
- 17 - EN 60601-1:2006/A1:2013
No. Essential Requirement Coverage
11.4 Flammable anaesthetics
11.5 Flammable agent
11.6.3 Spillage
11.8 Interruption of power supply
12.4 Hazardous output
13.1 Hazardous situations
13.2 Single Fault condition
15.3 Mechanical strength
15.4 Components and general assembly
15.5.3 Construction of transformers
16.3 Power supply
16.5 Separation devices
16.6 Leakage currents
16.8 Interruption of power supply

Not covered
- risks connected with reasonably
See for EMC EN 60601-1-2 as referenced in Annex
foreseeable environmental
ZA
conditions, such as magnetic fields,

external electrical influences,
See for acceleration EN 60601-1-11 and EN 60601-
electrostatic discharge, pressure,
1-12 as referenced in Annex ZA
temperature or variations in
pressure and acceleration;
Covered in respect of the following:
pressure, temperature: test in 5.3 according to
manufacturers' specification in 7.9.3.1

Not covered
- the risks of reciprocal interference

with other devices normally used in
See for EMC EN 60601-1-2 as referenced in annex
the investigations or for the
ZA
treatment given;
Not covered
- 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.
Covered in respect of the following:
9.3 Devices must be designed and

manufactured in such a way as to

minimize the risks of fire or explosion
Normal use 9.7.5 Pressure vessels,
during normal use and in single fault

condition.
Single fault condition:
11.2 Fire prevention
11.3 Fire enclosures
11.4 Flammable anaesthetics
Annex G ignition of flammable anaesthetic mixtures

Covered in respect of the following:
Particular attention must be paid to

devices whose intended use includes
11.4 Flammable anaesthetics
exposure to flammable substances or to

substances which could cause
Annex G ignition of flammable anaesthetic mixtures
combustion.
10 Devices with a measuring function
10.1 Devices with a measuring function must Not covered
be designed and manufactured in such

No. Essential Requirement Coverage
a way as to provide sufficient accuracy See particular standards EN 60601-2-xx
and stability within appropriate limits of
See 12.1 in respect of risks associated with accuracy
accuracy and taking account of the
of controls and instruments
intended purpose of the device.

The limits of accuracy must be indicated Covered by 7.9.3.1 technical description
by the manufacturer.
10.2 The measurement, monitoring and Not covered
display scale must be designed in line
see EN IEC 60601-1-6 and EN IEC 62366
with ergonomic principles, taking
account of the intended purpose of the
device.
10.3 The measurements made by devices Covered in respect of the following:
with a measuring function must be
7.4.3 Units of measurement
expressed in legal units conforming to
cmH2O is not included in 80/181/EEC
the provisions of Council Directive
80/181/EEC.
11 Protection against radiation General Guidance note 2 and 3 shall be observed
11.1 General
11.1.1 Devices shall be designed and
manufactured in such a way that
For unintended radiation, covered in respect to the
exposure of patients, users and other
following:
persons to radiation shall be reduced as
10.1.1 (ionizing radiation),
far as possible compatible with the
10.3 (microwave),
intended purpose, whilst not restricting
the application of appropriate specified
10.4 (lasers).
levels for therapeutic and diagnostic
For intended radiation, covered in respect to the
purposes.
following:
10.3 (microwave),
10.4 (lasers).
Other types of radiation of these devices and other
devices not covered.
For devices intended to produce radiation see EN
60601-1-3 for diagnostic x-radiation.
For other radiation see particular standards EN
60601-2-xx.
11.2 Intended radiation
st nd
11.2.1 Where devices are designed to emit 1 and 2 sentence covered in respect of the
hazardous levels of radiation necessary following:
for a specific medical purpose the
10.3, Microwave
benefit of which is considered to
10.4 Lasers
outweigh the risks inherent in the
First sentence covered by subclauses 15.4.6,
emission, it must be possible for the
Actuating parts of controls and 15.4.7 hand or foot
user to control the emissions. Such
switches
devices shall be designed and
manufactured to ensure reproducibility
See particular standards EN 60601-2-xx
and tolerance of relevant variable
parameters.
See EN 60601-1-3 for diagnostic x-radiation

11.2.2 Where devices are intended to emit Not covered.

- 19 - EN 60601-1:2006/A1:2013
No. Essential Requirement Coverage
potentially hazardous, visible and/or
invisible radiation, they must be fitted,
where practicable, with visual displays
and/or audible warnings of such
emissions.
11.3 Unintended radiation
11.3.1 Devices shall be designed and Covered in respect to the following:
manufactured in such a way that
10.1.1 (ionizing radiation),
exposure of patients, users and other
10.3 (microwave),
persons to the emission of unintended,
10.4 (lasers).
stray or scattered radiation is reduced
as far as possible. Other types of radiation of these devices and other
devices not covered.
11.4 Instructions
11.4.1 The operating instructions for devices Covered in respect of information relating to the
emitting radiation must give detailed nature of the emitted radiation:
information as to the nature of the
7.9.2.17 – ME equipment emitting radiation
emitted radiation, means of protecting

the patient and the user and on ways of
avoiding misuse and of eliminating the
risks inherent in installation.
11.5 Ionizing radiation
11.5.1 Devices intended to emit ionizing Not covered
radiation must be designed and
For diagnostic x-radiation see EN 60601-1-3.
manufactured in such a way as to
For other devices see particular standards EN
ensure that, where practicable, the
60601-2-xx
quantity, geometry and quality of

radiation emitted can be varied and
controlled taking into account the
intended use.
11.5.2 Devices emitting ionizing radiation Not covered For diagnostic x-radiation see EN
intended for diagnostic radiology shall 60601-1-3.
be designed and manufactured in such
For other devices see particular standards EN
a way as to achieve appropriate image
60601-2-xx
and/or output quality for the intended
medical purpose whilst minimizing
radiation exposure of the patient and
user.
11.5.3 Devices emitting ionizing radiation, Not covered
intended for therapeutic radiology shall
be designed and manufactured in such
a way as to enable reliable monitoring
and control of the delivered dose, the
beam type and energy and where
appropriate the quality of radiation.
12 Requirements for medical devices General Guidance note 2 and 3 shall be observed
connected to or equipped with an
energy source
12.1 Devices incorporating electronic Covered by
programmable systems must be
14 Programmable electrical medical systems
designed to ensure the repeatability,
(PEMS)
reliability and performance of these

systems according to
...