In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
I gcás feistí a cuireadh ar an margadh agus bail steiriúil orthu, measfar go ndearnadh dochar do bhail bhunaidh na feiste má osclaíodh an pacáistiú is gá le bail steiriúil a chothabháil, má milleadh é nó má rinneadh dochar eile dó tríd an athphacáistiú.