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
SIST EN 60601-1:2007/A1:2014
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
SIST EN 60601-1:2007/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-1:2007/A1:2014

---------------------- Page: 2 ----------------------

SIST EN 60601-1:2007/A1:2014

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

---------------------- Page: 3 ----------------------

SIST EN 60601-1:2007/A1:2014
EN 60601-1:2006/A1:2013 - 2 -


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
EN 60601-1:2006/A1:2013.
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
...