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

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 -
...