EU quality management system certificates and EU production quality assurance certificates for class A sterile devices shall include a statement that the audit by the notified body was limited to the aspects of manufacture concerned with securing and maintaining sterile conditions.
Áireofar ar dheimhnithe córais bainistithe cáilíochta AE agus ar dheimhnithe dearbhaithe cáilíochta táirgthe AE i gcás feistí steiriúla in aicme A ráiteas go raibh an t-iniúchadh a dhearna an comhlacht dá dtugtar fógra srianta do ghnéithe an mhonaraithe a bhaineann le bail steiriúil a áirithiú agus a chaomhnú.