SIST EN 60601-1:2007/A11:2012

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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability. In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1. 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.

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

Električna medicinska oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti

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: Withdrawn
• Publication Date: 14-Nov-2011
• Withdrawal Date: 12-Nov-2018
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 13-Nov-2018
• Due Date: 06-Dec-2018
• Completion Date: 13-Nov-2018
• 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
• Ref Project: EN 60601-1:2006/A11:2011 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Relations

• Amends: SIST EN 60601-1:2007 - Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
• Effective Date: 01-Jan-2012
• Replaced By: SIST EN 60601-1:2007/A1:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 01-Jan-2014
• Replaced By: SIST EN 60601-1:2007/A1:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 07-Jun-2022
• Amends: SIST EN 60601-1:2007 - Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023
• Replaced By: SIST EN 60601-1:2007/A1:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1:2007/A11:2012
01-januar-2012
(OHNWULþQDPHGLFLQVNDRSUHPDGHO6SORãQH]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/A11:2011
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007/A11:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1:2007/A11:2012

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SIST EN 60601-1:2007/A11:2012

EUROPEAN STANDARD
EN 60601-1/A11

NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM

ICS 11.040


English version


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



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






This amendment A11 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on
2011-10-01. 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, 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

Management Centre: Avenue Marnix 17, B -
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