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 verification Manufacturers shall present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced. A random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standard(s) referred to in Article 5, or equivalent tests shall be carried out to verify their conformity to the type as described in the EC type-examination certificate and thereby determine whether a batch is to be accepted or rejected.
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