in the case of devices for sterile use, evidence of the validation of the manufacturer's sterilisation procedures or information on the reconditioning and sterilisation procedures which have to be conducted by the investigation site;
i gcás feistí le haghaidh úsáid steiriúil, fianaise maidir le bailíochtú an mhonaróra nó faisnéis maidir le nósanna imeachta steirilithe athriochtaithe agus aimridiú na nósanna imeachta atá le déanamh ag an suíomh imscrúdaithe;