BS EN 60601-1-6:2004 - Medical electrical equipment. General requirements for safety. Collateral standard. Usability

BS EN 60601-1-6:2004

Medical electrical equipment. General requirements for safety. Collateral standard. Usability

Status : Revised, Superseded, Withdrawn   Published : November 2004 Replaced By : BS EN 60601-1-6:2007, BS EN 60601-1-6:2010+A1:2015,

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Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. use errors caused by inadequate medical electrical equipment usability have become an increasing cause for concern. The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is part of the process of risk control. This Collateral Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide medical electrical equipment safety. It addresses normal use and use errors but excludes abnormal use.




Standard NumberBS EN 60601-1-6:2004
TitleMedical electrical equipment. General requirements for safety. Collateral standard. Usability
StatusRevised, Superseded, Withdrawn
Publication Date17 November 2004
Withdrawn Date01 June 2012
Normative References(Required to achieve compliance to this standard)EN 60601-1:1990/AMD 2:1995, EN 60601-1:1990/AMD 1:1993, IEC 60601-1-8:2003, EN ISO 14971:2000/AMD 1:2003, EN ISO 14971:2000, ISO 14971:2000, IEC 60601-1:1988/AMD 2:1995, EN 60601-1-8:2004, EN ISO 14971:2000/Corrigendum:2002, EN 60601-1:1990/AMD 13:1996, IEC 60601-1:1988/Corrigendum:1995, EN 60601-1:1990/Corrigendum:1994, IEC 60601-1:1988/AMD 1:1991, IEC 60601-1:1988, EN 60601-1:1990, ISO 14971:2000/AMD 1:2003
Informative References(Provided for Information)IEC 61258:1994, ISO 9000:2000, ISO 9001:2000, ISO 9241-11:1998, GHTF SG2N31R8:2003, IEC Guide 51:1999, ANSI/AAMI HE 48:1993, ANSI/AAMI HE 74:2001, ISO 13485:2003
International RelationshipsEN 60601-1-6:2004,IEC 60601-1-6:2004
Draft Superseded By03/304741 DC
DescriptorsDesign, Electrical safety, Risk assessment, Medical equipment, Equipment safety, Electronic equipment and components, Electrical medical equipment, Electrical equipment, Ergonomics
ICS11.040.01
Title in FrenchAppareils electromedicaux. Regles generales de securite. Norme collaterale. Aptitude a l'utilisation
Title in GermanMedizinische elektrische Geraete. Allgemeine Festlegungen fuer die Sicherheit. Ergaenzungsnorm. Gebrauchstauglichkeit
CommitteeCH/62/1
ISBN0 580 44769 3
PublisherBSI
FormatA4
DeliveryNo
Pages78
File Size1.345 MB
Price£274.00


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