EN 60601-1:2006

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

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

Contient les exigences concernant la sécurité de base et les performances essentielles qui sont généralement applicables aux appareils électromédicaux. Pour certains types d'appareil électromédicaux, ces exigences sont soit complétées soit modifiées par des exigences spécifiques données dans une norme collatérale ou une norme particulière. Lorsqu'il existe une norme particulière, il est recommandé de ne pas utiliser la présente norme générale seule. Le contenu des corrigendum de décembre 2006, de juillet 20007, la feuille d'interprétation 1 d'abril 2008, la feuille d'interprétation 2 de janvier 2009 et la feuille d'interprétation 3 de mai 2013 a été pris en considération dans cet exemplaire.

Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti (IEC 60601-1:2005)

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: 19-Oct-2006
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 20-Oct-2006
• Completion Date: 20-Oct-2006
• 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
• Ref Project: SIST EN 60601-1:2007 - Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

Relations

• Replaces: EN 60601-1:1990/A1:1993 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-1-4:1996 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-1:1990/A2:1995 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-1-4:1996/A1:1999 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-1-1:2001 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-1:1990 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-1:1990/A13:1996 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-1:2006/A1:2013 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-1:2006/A11:2011 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-1:2006/A12:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 22-Jan-2023
• Amended By: EN 60601-1:2006/A2:2021 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 22-Jan-2023
• Corrected By: EN 60601-1:2006/AC:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 29-Jan-2023
• Corrected By: EN 60601-1:2006/AC:2022-12 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 22-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1:2007
01-marec-2007
1DGRPHãþD
SIST EN 60601-1:1995
SIST EN 60601-1:1995/A13:1998
SIST EN 60601-1:1995/A2:1998
SIST EN 60601-1-1:2002
SIST EN 60601-1-4:1998
SIST EN 60601-1-4:1998/A1:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQH]PRJOMLYRVWL,(&
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
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1:2007

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SIST EN 60601-1:2007


EUROPEAN STANDARD
EN 60601-1

NORME EUROPÉENNE
October 2006
EUROPÄISCHE NORM

ICS 11.040 Supersedes EN 60601-1:1990 + amendments
Incorporates corrigendum March 2010


English version


Medical electrical equipment
Part 1: General requirements for basic safety
and essential performance
(IEC 60601-1:2005)


Appareils électromédicaux  Medizinische elektrische Geräte
Partie 1: Exigences générales Teil 1: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
(CEI 60601-1:2005) (IEC 60601-1:2005)




This European Standard was approved by CENELEC on 2006-09-12. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
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 Central Secretariat or to any CENELEC member.

This European Standard 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


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

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SIST EN 60601-1:2007
EN 60601-1:2006 - 2 -
Foreword
The text of document 62A/505A//FDIS, future edition 3 of IEC 60601-1, 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 was approved by CENELEC
as EN 60601-1 on 2006-09-12.
The following date was fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2007-07-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-06-01

This European Standard supersedes EN 60601-1:1990 and its amendments.
This EN 60601-1:2006 has been significantly restructured compared to EN 60601-1:1990.
Requirements in the electrical section have been further aligned with those for information technology
equipment covered by EN 60950-1 and a requirement for including a RISK MANAGEMENT
PROCESS has been added. For an expanded description of this revision, see Clause A.3.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directives 90/385/EEC and 93/42/EEC. See Annex ZZ.
In this standard the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in italic type;
− informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text
of tables is also in a smaller type;
− TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN
...