CENELEC - EN 62366
Medical devices - Application of usability engineering to medical devices
| Organization: | CENELEC |
| Publication Date: | 1 January 2008 |
| Status: | inactive |
| Page Count: | 104 |
| ICS Code (Medical equipment): | 11.040 |
scope:
This International Standard specifies a PROCESS
for a MANUFACTURER to analyse, specify,
design, VERIFY and VALIDATE USABILITY,
as it relates to SAFETY of a
MEDICAL DEVICE. 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.
NOTE For the purposes of this standard, USABILITY (see 3.17) is
limited to characteristics of the USER INTERFACE.
If the USABILITY ENGINEERING PROCESS
detailed in this International Standard has been complied
with and the acceptance criteria documented in the
USABILITY VALIDATION plan have been met (see 5.9), then
the RESIDUAL RISKS, as defined in ISO 14971,
associated with USABILITY of a MEDICAL
DEVICE are presumed to be acceptable, unless there
is OBJECTIVE EVIDENCE to the contrary (see
4.1.2).
This International Standard does not apply to clinical
decision-making relating to the use of a MEDICAL
DEVICE.
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