IEC 60601-1-6:2010+A1:2013 specifies a process for a manufacturer toanalyse, 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.
This consolidated version consists of the third edition (2010)
and its amendment 1 (2013). Therefore, no need to order amendment in
addition to this publication.
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