EN 60601-1:2006/A2:2021

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

2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant

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 osnovno varnost in bistvene zmogljivosti - Dopolnilo A2 (IEC 60601-1:2005/A2:2020)

General Information

• Status: Published
• Publication Date: 07-Oct-2021
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• 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: 08-Oct-2021
• Completion Date: 08-Oct-2021
• 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
• 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/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
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/MDR - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: SIST EN 60601-1:2007/A2:2021 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)

Relations

• Amends: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 22-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2021
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in
bistvene zmogljivosti - Dopolnilo A2 (IEC 60601-1:2005/A2:2020)
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005/A2:2020)
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale (IEC 60601-1:2005/A2:2020)
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles (IEC 60601-1:2005/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1:2006/A2:2021
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/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2021
ICS 11.040.01
English Version
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
(IEC 60601-1:2005/A2:2020)
Appareils électromédicaux - Partie 1: Exigences générales Medizinische elektrische Geräte - Teil 1: Allgemeine
pour la sécurité de base et les performances essentielles Festlegungen für die Basissicherheit einschließlich der
(IEC 60601-1:2005/A2:2020) wesentlichen Leistungsmerkmale
(IEC 60601-1:2005/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on 2020-09-24. 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, 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,
Turkey 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1:2006/A2:2021 E

European foreword
The text of document 62A/1389/FDIS, future IEC 60601-1/A2, 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 to be implemented at national (dop) 2022-04-08
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-10-08
document have to be withdrawn
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.
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.
Endorsement notice
The text of the International Standard IEC 60601-1:2005/A2:2020 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 60601-2-57 NOTE Harmonized as EN 60601-2-57
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
ISO 2409 NOTE Harmonized as EN ISO 2409
ISO 4624 NOTE Harmonized as EN ISO 4624
ISO 10524-1:2018 NOTE Harmonized as EN ISO 10524-1:2019 (not modified)
ISO 13732-1:2006 NOTE Harmonized as EN ISO 13732-1:2008 (not modified)
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.cenelec.eu.
Replace Annex ZA by the following one:
Publication Year Title EN/HD Year
IEC 60065 2001 Audio, video and similar electronic - -
apparatus - Safety requirements
+ A1 2005  - -
+ A2 2010  - -
IEC 60068-2-2 2007 Environmental testing - Part 2-2: Tests - EN 60068-2-2 2007
Test B: Dry heat
IEC 60079-0 - Explosive atmospheres - Part 0: EN IEC 60079-0 -
Equipment - General requirements
IEC 60079-2 - Explosive atmospheres - Part 2: EN 60079-2 -
Equipment protection by pressurized
enclosure "p"
IEC 60079-5 - Explosive atmospheres - Part 5: EN 60079-5 -
Equipment protection by powder filling "q"
IEC 60079-6 - Explosive atmospheres - Part 6: EN 60079-6 -
Equipment protection by liquid 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 EN 60085 -
and designation
IEC 60086-4 - Primary batteries - Part 4: Safety of EN IEC 60086-4 -
lithium batteries
IEC 60112 - Method for the determination of the proof EN IEC 60112 -
and the comparative tracking indices of
solid insulating materials
IEC 60127-1 - Miniature fuses - Part 1: Definitions for EN 60127-1 -
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
Publication Year Title EN/HD Year
IEC 60245-1 2003 Rubber insulated cables - Rated voltages - -
up to and including 450/750 V -- Part 1:
General requirements
+ A1 2007  - -
IEC 60252-1 - AC motor capacitors - Part 1: General - EN 60252-1 -
Performance, testing and rating - Safety
requirements - Guidance for installation
and operation
IEC 60320-1 - Appliance couplers for household and EN 60320-1 -
similar general purposes - Part 1:
General requirements
IEC 60335-1 (mod) 2010 Household and similar electrical EN 60335-1 2012
appliances - Safety - Part 1: General
requirements
- -  + A11 2014
- -  + AC 2014
- -  + A13 2017
- -  + A14 2019
- -  + A15 2021
IEC 60364-4-41 - Low-voltage electrical installations - Part HD 60364-4-41 -
4-41: Protection for safety - Protection
against electric shock
IEC 60384-14 2005 Fixed capacitors for use in electronic - -
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. - -
Index, survey and compilation of the
single sheets.
IEC 60445 - Basic and safety principles for man- - -
machine interface, marking and
identification – Identification of equipment
terminals and of terminations of certain
designated conductors, including general
rules for an alphanumeric system
IEC 60447 - Basic and safety principles for man- EN 60447 -
machine interface, marking and
identification - Actuating principles
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
- -  + corrigendum 1993
May
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020  + A1 2021
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety
and essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
Publication Year Title EN/HD Year
- -  + corrigendum 2010
Mar.
+ A1 2013  + A1 2013
- -  + AC 2014
- -  + A11 2016
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety
and essential performance - Collateral
standard: Usability
+ A1 2013  + A1 2015
+ A2 2020  + A2 2021
IEC 60601-1-8 2006 Medical electrical equipment – 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
+ A1 2012  + A1 2013
- -  + AC 2014
+ A2 2020  + A2 2021
IEC 60664-1 2007 Insulation coordination for equipment EN 60664-1 2007
within low-voltage systems - Part 1:
Principles, requirements and tests
IEC 60695-11-10 - Fire hazard testing - Part 11-10: Test EN 60695-11-10 -
flames - 50 W horizontal and vertical
flame test methods
IEC 60730-1 (mod) 2010 Automatic electrical controls for EN 60730-1 2011
household and similar use -- Part 1:
General requirements
IEC 60747-5-5 2007 Semiconductor devices - Discrete EN 60747-5-5 2011
devices - Part 5-5: Optoelectronic
devices - Photocouplers
IEC 60825-1 2014 Safety of laser products - Part 1: EN 60825-1 2014
Equipment classification and
requirements
- -  + A11 2021
- -  /AC 2017
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: - -
Thermal properties
IEC 60884-1 - Plugs and socket-outlets for household - -
and similar purposes -- Part 1: General
requirements
IEC 60950-1 2005 Information technology equipment - - -
Safety - Part 1: General requirements
+ A1 2009  - -
+ A2 2013  - -
Publication Year Title EN/HD Year
IEC 61058-1 2000 Switches for appliances -- Part 1: - -
General requirements
+ 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 -
IEC 62133 - Secondary cells and batteries containing - -
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 -
alkaline or other non-acid electrolytes -
Safety requirements for portable sealed
secondary lithium cells, and for batteries
made from them, for use in portable
applications - Part 2: Lithium systems
IEC 62304 2006 Medical device software - Software life EN 62304 2006
cycle processes
- -  + corrigendum 2008
Nov.
IEC 62368-1 2018 Audio/video, information and EN IEC 62368-1 2020
communication technology equipment -
Part 1: Safety requirements
ISO 780 - Packaging – Pictorial marking for EN ISO 780 -
handling of goods
ISO 1853 - Conducting and dissipative rubbers, - -
vulcanized or thermoplastic -
Measurement of resistivity
ISO 2878 - Rubber, vulcanized or thermoplastic - - -
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 EN ISO 3746 -
power levels and sound energy levels of
noise sources using sound pressure -
Survey method using an enveloping
measurement surface over a reflecting
plane
Publication Year Title EN/HD Year
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 - Graphical symbols for use on equipment - -
- Registered symbols
ISO 7010 2019 Graphical symbols - Safety colours and - -
safety signs - Registered safety signs
ISO 9614-1 - Acoustics - Determination of sound EN ISO 9614-1 -
power 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 - - -
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 2015
Radiation – Part 1: Requirements for
development, validation and routine
control of a sterilization process for
...