Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005.

Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Elektromagnetische Verträglichkeit - Anforderungen und Prüfungen

Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Compatibilité électromagnétique - Exigences et essais

Cette norme collatérale s'applique à la compatibilité électromagnétique des appareils et des systèmes électromédicaux. La présente norme collatérale a pour objet de spécifier les exigences générales ainsi que les essais pour la compatibilité électromagnétique des appareils et des systèmes electromédicaux. Elles viennent en complément des exigences de la norme générale et servent de base pour les normes particulières. La présente édition de la CEI 60601-1-2 a été révisée en vue d'un alignement structurel avec l'édition de 2005 de la CEI 60601-1 et pour implémenter la décision du sous-comité 62A de la CEI qui stipule que la structure de numérotation des articles des normes collatérales de la CEI 60601-1:2005 devrait respecter la forme spécifiée dans les Directives ISO/CEI, Partie 2:2004. Les modifications techniques principales se trouvent à l'Article 4, qui reconnaît à présent qu'il existe une exigence générale pour le processus de gestions des risques dans la CEI 60601-1:2005.

Medicinska električna oprema - 1-2. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Elektromagnetna združljivost - Zahteve in preskušanje (IEC 60601-1-2:2007) (vsebuje popravek AC:2010)

General Information

Status
Withdrawn
Publication Date
30-Jul-2007
Withdrawal Date
31-May-2012
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
31-Dec-2018
Completion Date
31-Dec-2018

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.&Medizinische elektrische Geräte -- Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Elektromagnetische Verträglichkeit - Anforderungen und PrüfungenAppareils électromédicaux -- Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Compatibilité électromagnétique - Exigences et essaisMedical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 60601-1-2:2007SIST EN 60601-1-2:2008en,fr,de01-januar-2008SIST EN 60601-1-2:2008SLOVENSKI
STANDARDSIST EN 60601-1-2:2002/A1:2006SIST EN 60601-1-2:20021DGRPHãþD



SIST EN 60601-1-2:2008



EUROPEAN STANDARD EN 60601-1-2 NORME EUROPÉENNE
EUROPÄISCHE NORM July 2007
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
© 2007 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-2:2007 E
ICS 11.040.01; 33.100.10; 33.100.20 Supersedes EN 60601-1-2:2001 + A1:2006Incorporates corrigendum March 2010
English version
Medical electrical equipment -
Part 1-2: General requirements for basic safety
and essential performance -
Collateral standard: Electromagnetic compatibility -
Requirements and tests (IEC 60601-1-2:2007, modified)
Appareils électromédicaux -
Partie 1-2: Exigences générales
pour la sécurité de base
et les performances essentielles -
Norme collatérale:
Compatibilité électromagnétique -
Exigences et essais (CEI 60601-1-2:2007, modifiée)
Medizinische elektrische Geräte -
Teil 1-2: Allgemeine Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale -
Ergänzungsnorm:
Elektromagnetische Verträglichkeit -
Anforderungen und Prüfungen (IEC 60601-1-2:2007, modifiziert)
This European Standard was approved by CENELEC on 2007-04-11. 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, Bulgaria, 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.
SIST EN 60601-1-2:2008



EN 60601-1-2:2007
- 2 - Foreword The text of document 62A/560/FDIS, future edition 3 of IEC 60601-1-2, 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 60601-1-2 on 2007-04-11. 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
– latest date by which the national standards conflicting
with the EN have to be withdrawn
(dop)
(dow)
2008-02-01
2012-06-01 This European Standard supersedes EN 60601-1-2:2001 and its amendment A1:2006.
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 Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard. This EN 60601-1-2 was revised to structurally align it with EN 60601-1:2006 and to implement the decision of IEC SC 62A that the clause numbering structure of collateral standards written to EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in EN 60601-1:2006. In the 60601 series of publications, collater
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