BS EN 60601-1-6:2007 - Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Usability
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BS EN 60601-1-6:2007

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Usability

Status : Revised, Superseded, Withdrawn   Published : November 2007 Replaced By :

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Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.




Standard NumberBS EN 60601-1-6:2007
TitleMedical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Usability
StatusRevised, Superseded, Withdrawn
Publication Date30 November 2007
Withdrawn Date01 April 2013
Normative References(Required to achieve compliance to this standard)EN ISO 14971:2000, EN 60601-1-8:2007, IEC 60601-1:2005, IEC 60601-1-8:2006, ISO 14971:2000, EN 60601-1:2006, ISO/IEC 14971:2000, EN ISO 14971:2000/Corrigendum:2002
Informative References(Provided for Information)ISO/IEC Guide 51:1999, ANSI/AAMI HE 48:1993, EN ISO 9001:2000, EN ISO 9000:2000, ANSI/AAMI HE 74:2001, EN ISO 9241-11:1998, 93/42/EEC, EN ISO 13485:2003, ISO 13485:2003, ISO 9241-11:1998, ISO 9001:2000, IEC 61258:1994, ISO 9000:2000
ReplacesBS EN 60601-1-6:2004
International RelationshipsEN 60601-1-6:2007/corrigendum,IEC 60601-1-6:2006
Amended ByCorrigendum, July 2010; Corrigendum, June 2008
DescriptorsElectronic equipment and components, Equipment safety, Electrical equipment, Risk assessment, Electrical safety, Design, Electrical medical equipment, Ergonomics, Medical equipment
ICS11.040.01
Title in FrenchAppareils électromédicaux. Exigences générales pour la sécurité de basse et les performance essentielles. Norme collatérale. Aptitude à l'utilisation
Title in GermanMedizinische elektrische Geräte. Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm. Gebrauchstauglichkeit
CommitteeCH/62/1
ISBN978 0 580 70930 2
PublisherBSI
FormatA4
DeliveryNo
Pages78
File Size1.445 MB
Price£274.00


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