For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons.
I gcás grúpaí táirgí nár beartaíodh críoch leighis dóibh dá dtagraítear in Iarscríbhinn XVI, is é an chiall a bhainfear as na ceanglais ghinearálta sábháilteachta a leagtar amach i Roinn 1 agus i Roinn 8 nach mbeidh úsáid na feiste, nuair a úsáidtear í sna dálaí ar ann a beartaíodh í a úsáid agus chun na críche a beartaíodh di, ina riosca ar bith nó nach mbeidh riosca níos airde ag baint léi ná an t-uasriosca is inghlactha agus go mbeidh sí ag teacht le hardleibhéal cosanta do shábháilteacht agus do shláinte daoine.