Does anyone have any examples they could share on the application of IEC 62366 to a non-active medical device (non-electical). Since the standard was issued by the IEC from a subcommitted focused on electric medical devices, naturally the standard is focused on electrical devices. However, this is the only harmonized standard for usability in the EU and essential requirement #1 requires that I reduce the risk of use error as far as possible.
I know auditors that have written findings that IEC 62366 was not considered for a non-active medical device. Of course the standard is not law, but I must justify the equivalence of any alternative approach that I take.
I know auditors that have written findings that IEC 62366 was not considered for a non-active medical device. Of course the standard is not law, but I must justify the equivalence of any alternative approach that I take.