International Electrotechnical Commission

Medical devices – Application of usability engineering to medical devices - Edition 1.0
 N 62366

Annotation

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.

Автоматический перевод:

Медицинские устройства – Применение разработки удобства пользования к медицинским устройствам - Издание 1.0

Этот Международный стандарт определяет PROCESS для MANUFACTURER, чтобы проанализировать, определить, проектировать, VERIFY и VALIDATE USABILITY, поскольку он касается SAFETY MEDICAL DEVICE. Этот USABILITY ENGINEERING PROCESS оценивает и снижает RISKS, вызванный проблемами USABILITY, связанными с CORRECT USE и USE ERRORS, т.е. NORMAL USE. Это может использоваться для идентификации, но не оценивает или снижает RISKS, связанный с ABNORMAL USE.