EN 60601-1:2006/A13:2024

Medical electrical equipment - Part 1: General requirements for safety

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 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

Medicinska električna oprema - 1. del: Splošne zahteve za varnost - Dopolnilo A13

General Information

• Status: Published
• Publication Date: 18-Apr-2024
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 19-Apr-2024
• Due Date: 01-Jun-2025
• Completion Date: 19-Apr-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN 60601-1:2007/A13:2024 - Medical electrical equipment - Part 1: General requirements for safety

Relations

• Amends: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 14-Feb-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2024
Medicinska električna oprema - 1. del: Splošne zahteve za varnost - Dopolnilo A13
Medical electrical equipment - Part 1: General requirements for safety
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/A13:2024
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 60601-1:2006/A13

NORME EUROPÉENNE
EUROPÄISCHE NORM April 2024
ICS 11.040
English Version
Medical electrical equipment - Part 1: General requirements for
safety
Appareils électromédicaux - Partie 1: Exigences générales Medizinische elektrische Geräte - Teil 1: Allgemeine
pour la sécurité de base et les performances essentielles Festlegungen für die Sicherheit einschließlich der
wesentlichen Leistungsmerkmale
This amendment A13 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on 2024-02-28. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1:2006/A13:2024 E

Contents Page
European foreword . 3
1 Replacement of Annex ZA, Annex ZZA and Annex ZZB . 4
Annex ZA (normative) Normative references to international publications with their
corresponding European publications . 5
Annex ZZ (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 12
European foreword
This document (EN 60601-1:2006/A13:2024) has been prepared by CLC/TC 62 "Electrical Equipment in
medical practice".
The following dates are fixed:
• latest date by which this document has to be (dop) 2025-02-28
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) 2027-02-28
conflicting with this document have to be
withdrawn
This amendment A13 modifies EN 60601-1:2006, and EN 60601-1:2006/A1:2013 and
EN 60601-1:2006/A2:2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CENELEC by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part of this document.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
1 Replacement of Annex ZA, Annex ZZA and Annex ZZB
Replace Annex ZA, Annex ZZA and Annex ZZB with the following:
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60065 (mod) 2001 Audio, video and similar electronic apparatus - EN 60065 2002
Safety requirements
Cor. March 2006
+ A1 (mod) 2005  + A1 2006
Cor. August 2007
+ A11 2008
+ A2 (mod) 2010 + A2 2010
+ A12 2011
IEC 60068-2-2 2007 Environmental testing Part 2-2: Tests - Test B: EN 60068-2-2 2007
Dry heat
IEC 60079-0 - Explosive atmospheres - Part 0: Equipment - EN IEC 60079-0 2018
General requirements
(mod)
+ AC 2020
IEC 60079-2 - Explosive atmospheres - Part 2: Equipment EN 60079-2 2014
protection by pressurized enclosure "p"
+ AC 2015
IEC 60079-5 - Explosive atmospheres - Part 5: Equipment EN 60079-5 2015
protection by powder filling "q"
IEC 60079-6 - Explosive atmospheres - Part 6: Equipment EN 60079-6 2015
protection by liquid immersion "o"
IEC/TR 60083 2015 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 2008
designation
Dated as no European equivalent exists.
IEC 60086-4 - Primary batteries Part 4: Safety of lithium EN IEC 60086-4 2019
batteries
+ AC 2019
+ AC 2020
IEC 60112 - Method for the determination of the proof and EN IEC 60112 2020
the comparative tracking indices of solid
insulating materials
IEC 60127-1 - Miniature fuses Part 1: Definitions for miniature EN 60127-1 2006
fuses and general requirements for miniature
+ A1 2011
fuse-links
+ A2 2015
IEC 60227-1 2007 Polyvinyl chloride insulated cables of rated EN 50525-1 2011
voltages up to and including 450/750 V Part 1:
General requirements
IEC 60245-1 2003 Rubber insulated cables - Rated voltages up to EN 50525-1 2011
and including 450/750 V Part 1: General
+ A1 2007
requirements
IEC 60252-1 - + AC motor capacitors Part 1: General - EN 60252-1 2011
Performance, testing and rating - Safety
+ A1 2013
requirements - Guidance for installation and
operation
IEC 60320-1 - Appliance couplers for household and similar EN IEC 60320-1 2021
general purposes Part 1: General
requirements
IEC 60335-1 (mod) 2010 Household and similar electrical appliances - EN 60335-1 2012
Safety Part 1: General requirements
+ AC 2014
+ A11 2014
+ A12 2017
IEC 60364-4-41 - Low-voltage electrical installations Part 4-41: HD 60364-4-41 2017
(mod) Protection for safety - Protection against
+ A11 2017
electric shock
+ A12 2019
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 Data Graphical symbols for use on equipment - -
base available from http://www.graphical-
symbols.info/equipment
IEC 60445 - Basic and safety principles for man-machine EN IEC 60445 2021
interface, marking and identification -
Identification of equipment terminals,
conductor terminations and conductors
IEC 60447 - Basic and safety principles for man-machine EN 60447 2004
interface, marking and identification - Actuating
principles
EN 50525-1:2011, Electric cables - Low voltage energy cables of rated voltages up to and including 450/750
V (U0/U) - Part 1: General requirements, which is related to, but not directly equivalent with, IEC 60227-1 and
IEC 60245-1, applies instead.
IEC 60447 - Basic and safety principles for man-machine EN 60447 2004
interface, marking and identification - Actuating
principles
IEC 60529 1989 Degrees of protection provided by enclosures EN 60529 1991
(IP Code)
+ A1 1999 Cor. May 1993
+ A1 2000
IEC 60601-1-2 2014 Medical electrical equipment Part 1-2: General EN 60601-1-2 2015
requirements for basic safety and essential
+ A1 2020 + A1 2021
performance - Collateral standard:
Electromagnetic disturbances- Requirements
and tests
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
2013 Cor. March 2010
essential performance - Collateral Standard:
+ A1 + A1 2013
Radiation protection in diagnostic X-ray
+ AC 2014
equipment
+ A11 2016
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
2013 Cor. March 2010
essential performance - Collateral Standard:
+ A1 + A1 2013
Radiation protection in diagnostic X-ray
+ AC 2014
equipment
+ A11 2016
IEC 60601-1-6 2010 Medical electrical equipment Part 1-6: General EN 60601-1-6 2010
requirements for basic safety and essential
+ A1 2013 + A1 2015
performance - Collateral standard: Usability
+ A2 2020 + A2 2021
IEC 60601-1-8 2006 Medical electrical equipment Part 1-8: General EN 60601-1-8 2007
requirements for basic safety and essential
Cor. March 2010
performance - Collateral Standard: General
+ A1 2012 + A1 2013
requirements, tests and guidance for alarm
+ AC 2014
systems in medical electrical equipment and
medical electrical systems + A11 2017
+ A2 2020 + A2 2021
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 - Part 11-10: Test flames - EN 60695-11-10 2013
50 W horizontal and vertical flame test
+ AC 2014
methods
IEC 60730-1 2010 Automatic electrical controls for household and EN 60730-1 2011
similar use Part 1: General requirements
(mod)
IEC 60747-5-5 2007 Semiconductor devices - Discrete devices - EN 60747-5-5 2011
Part 5-5: Optoelectronic devices -
Photocouplers
IEC 60825-1 2014 Safety of laser products - Part 1: Equipment EN 60825-1 2014
classification and requirements
+ AC 2017
+ A11 2021
+ AC 2022
IEC 60851-3 2009 Winding wires - Test methods - Part 3: EN 60851-3 2009
Mechanical properties
IEC 60851-5 2008 Winding wires - Test methods - Part 5: EN 60851-5 2008
Electrical properties
IEC 60851-6 1996 Winding wires - Test methods - Part 6: EN 60851-6 1996
Thermal properties
+ A1 1997 + A1 1997
IEC 60851-6 1996 Winding wires - Test methods EN 60851-6 1996
Part 6: Thermal properties
+ A1 1997 + A1 1997
IEC 60884-1 - Plugs and socket-outlets for household and IEC 60884-1 2022
similar purposes - Part 1: General
requirements
IEC 60950-1 2005 Information technology equipment - Safety - EN 60950-1 2006
Part 1: General requirements
(mod)  + A11 2009
+ A1 2009 + A1 2010
2013 + A12 2011
+ AC 2011
+ A2 + A2 2013
IEC 61058-1 2000 Switches for appliances - Part 1: General EN 61058-1 2002
requirements
(mod)  + A2 2008
+ A1 2001
+ A2 2007
IEC 61558-2-1 - Safety of power transformers, power supplies, EN 61558-2-1 2007
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 2013
Part 1: Specifications
IEC 61672-2 - Electroacoustics - Sound level meters EN 61672-2 2013
Part 2: Pattern evaluation tests
+ A1 2017
IEC 61965 - Mechanical safety of cathode ray tubes EN 61965 2003
IEC 62133 - Secondary cells and batteries containing EN 62133 2013
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 62133-2 - Secondary cells and batteries containing EN 62133-2 2017
alkaline or other non-acid electrolytes - Safety
+ A1 2021
requirements for portable sealed secondary
+ AC 2022
cells, and for batteries made from them, for
use in portable applications - Part 2: Lithium
systems
IEC 62304 2006 Medical device software – Software lifecycle EN 62304 2006
processes
Cor. Nov. 2008
+ A1 2015 + A1 2015
IEC 62368-1 2018 Audio/video, information and communication EN IEC 62368-1 2020
technology equipment - Part 1: Safety
+ A11 2020
requirements
+ AC 2020
ISO 780 - Packaging - Distribution packaging - Graphical EN ISO 780 2015
symbols for handling and storage of packages
ISO 1853 2018 Conducting and dissipativ
...