IEC 60601-1-6:2004 Withdrawn

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

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Abstract

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.

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Additional information

Publication typeInternational Standard
Publication date2004-06-24
Edition1.0
Available language(s)English, English/French, French, Spanish
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
Pages147
File size1691 KB

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