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meditsiiniline in vitro diagnostikavahend - füsioloogilise või patoloogilise seisundi kohta või
- concerning a physiological or pathological state, or
Son Güncelleme: 2014-10-23
Kullanım Sıklığı: 1
Kalite:
tarvik — toode, mis ei ole küll iseenesest meditsiiniline in vitro diagnostikavahend, kuid mille tootja on spetsiaalselt ette näinud kasutamiseks koos sellise vahendiga, võimaldamaks nimetatud vahendit kasutada sihtotstarbel.
(c) 'accessory` means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.
Son Güncelleme: 2014-10-23
Kullanım Sıklığı: 1
Kalite:
"c) meditsiiniline in vitro diagnostikavahend - iga meditsiinivahend, mis on reagent, reagentaine, kalibraator, kontrollaine, testpakend, instrument, seade, aparatuur või süsteem, mida kasutatakse eraldi või teistega kombineerituna ja mille tootja on ette näinud kasutamiseks in vitro inimkehast saadud proovide, sealhulgas loovutatud vere ja kudede uurimisel üksnes või peamiselt järgmise informatsiooni saamiseks:
'(c) "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: