Statistiliseks vastavustõenduseks peab tootja esitama meditsiiniseadmed partiidena, millest valitakse pisteliselt selline kohustuslik arv näidiseid, mis tagab piirkvaliteedi, milleks loetakse viieprotsendiline tõenäoline aktsepteeritavus. Pistelise valiku meetodid on kehtestatud asjaomaste seadmete standardites.
Statistical control of products will be based on attributes, entailing a sampling system ensuring a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity percentage of between 3 and 7 %. The sampling method will be established by the harmonized standards referred to in Article 5, taking account of the specific nature of the product categories in question.
