IEC 60601-1-6 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. 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. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors.
EN 60601-1-6:2010 can be used to identify but does not assess or mitigate risks associated with abnormal use. Much of ME equipment developed without applying a usability engineering process is non-intuitive and difficult to learn and use. As healthcare evolves, less skilled operators including patients themselves are now using medical electrical equipment while the equipment itself is becoming more complicated. 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.
IEC 60601-1-6:2010/A1:2013 is intended to clarify the elements of the usability engineering process that are required for compliance with the IEC 60601 series. IEC/SC 62A subcommittee initiated a process to identify high-priority issues that need to be considered in an amendment and should not wait until the fourth edition of IEC 60601-1-6. Those issues selected for are addressed in Amendment 2. This consolidated version consists of the main text and both amendments, which can also be found separately from the standards history. The text of IEC 60601-1-6:2010 has been approved in Europe as EN 60601-1-6:2010 without any changes.
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