reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
na rioscaí a laghdú a oiread is féidir a bhaineann le gnéithe eirgeanamaíocha na feiste agus leis an timpeallacht ar ann a beartaíodh í a úsáid (dearadh ar mhaithe le sábháilteacht othar), agus