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Normas BSI – AENOR
BS EN 60601-1-6:2004

BS EN 60601-1-6:2004

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

Fecha Anulación:
2012-06-01 /Withdrawn
Comité:
CH/62/1
Equivalencias internacionales:

EN 60601-1-6:2004

IEC 60601-1-6:2004

Relación con otras normas BSI:

Reemplazada por: BS EN 60601-1-6:2007

Reemplazada por: BS EN 60601-1-6:2010+A1:2015

Resumen:
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.
Keywords:
Design, Electrical safety, Risk assessment, Medical equipment, Equipment safety, Electronic equipment and components, Electrical medical equipment, Electrical equipment, Ergonomics
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