Its depth and extent shall be proportionate and appropriate to the characteristics of the device including the risks, risk class, performance and its intended purpose.
Beidh doimhneacht agus fairsinge na meastóireachta sin comhréireach agus iomchuí i dtaca le saintréithe na feiste lena n-áirítear na rioscaí, an aicme riosca, an fheidhmíocht agus an chríoch a beartaíodh di.