EN IEC 60601-1-6:2010 specifies the process for any manufacturer of MEDCIAL EQUIPMENT AND MEDICAL SYSTEMS to analyze, 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.
Usability can be part of the formal compliance process for the U.S.-FDA, Canada-Health Canada, and the EU Medical Device Directive 93/42/EEC.
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, then the residual risks, as defined in ISO 14971, associated with usability of ME EQUIPMENT and ME SYSTEMS are presumed to be acceptable, unless there is objective evidence to the contrary.
The object of EN IEC 60601-1-6 collateral standard is to specify general requirements that are in addition to those of the general standard, EN IEC 60601-1-1 and to serve as the basis for additional collateral or particular standards.
To establish the requirements of EN IEC 60601-1-6 as it pertains to your equipment or system, contact the D.L.S. staff for a detailed review.