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 phacáistíocht a bhfuil gá léi chun an bhail steiriúil a chaomhnú, má milleadh í nó má rinneadh difear ar shlí eile di tríd an athphacáistiú.