In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility.
I gcás feistí a chuirtear ar an margadh i mbail steiriúil, tuairisc ar na modhanna a úsáideadh, lena n-áirítear na tuarascálacha bailíochtaithe, maidir le pacáistiú, steiriliú agus cothabháil steirilíochta.