the demonstration of compliance of the device(s) for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects.
an dtaispeántar go gcomhlíonann an fheiste nó na feistí le haghaidh staidéar feidhmíochta na ceanglais ghinearálta sábháilteachta agus feidhmíochta is infheidhme, seachas na gnéithe a chumhdaítear faoin staidéar feidhmíochta, agus, maidir leis na gnéithe sin, an ndearnadh gach réamhchúram chun sláinte agus sábháilteacht na n-ábhar a chosaint.