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Full Description

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.
 

Document History

  1. IEC 60601-1-6 Ed. 3.2 b:2020


    Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability CONSOLIDATED EDITION

    • Most Recent
  2. IEC 60601-1-6 Ed. 3.1 b:2013


    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability CONSOLIDATED EDITION

    • Historical Version
  3. IEC 60601-1-6 Ed. 3.0 b:2010


    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

    • Historical Version
  4. IEC 60601-1-6 Ed. 2.0 b:2006


    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

    • Historical Version
  5. IEC 60601-1-6 Ed. 1.0 b:2004

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

    • Historical Version