IEC 60601-1-6:2006

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.

IEC 60601-1-6:2010 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. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.