Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the lay person's technique and environment.
Déanfar feistí a beartaíodh lena n-úsáid ag tuataí a dhearadh agus a mhonarú sa chaoi go bhfeidhmeoidh siad mar is iomchuí chun na críche a beartaíodh dóibh, ag cur san áireamh na scileanna agus na modhanna atá ar fáil ag tuataí agus an tionchar a bhféadfaí a bheith ag súil leis le réasún a thiocfadh as athruithe ar theicnící agus timpeallacht an tuata.