| Standardization field | Health, environment and medical equipment |
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| Technical committee | BAS/TC 25- Healthcare |
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| Term (EN) | in vitro diagnostic medical device
IVD medical device |
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| Definition (EN) | device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles
[SOURCE: ISO 18113-1:2022, 3.1.33, modified — "medical" has been removed from the beginning of the definition. "and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles" has been added to the end of the definition. Notes 1 and 2 to entry have been removed.] |
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| Term (FR) | |
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| Definition (FR) | |
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| Term (DE) | |
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| Definition (DE) | |
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| Term (BS) | in vitro dijagnostički medicinski uređaj
IVD medicinski uređaj |
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| Definition (BS) | uređaj, bilo da se koristi samostalno ili kombinirano, namijenjen od strane proizvođača za in vitro ispitivanje uzoraka uzetih iz ljudskog tijela isključivo ili uglavnom u cilju dobijanja informacija za postavljanje dijagnoze, praćenje ili kompatibilne svrhe i uključujući reagense, kalibratore, kontrolne materijale, posude za uzorke, softver, i povezane instrumente ili opremu ili druge predmete
[IZVOR: ISO 18113-1:2022, 3.1.33, modificirana — "medicinski" je uklonjeno s početka definicije. "i uključujući reagense, kalibratore, kontrolne materijale, posude za uzorke, softver, i povezane instrumente ili opremu ili druge predmete " je dodano na kraj definicije. Napomene 1 i 2 su uklonjene.] |
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| Term (HR) | |
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| Definition (HR) | |
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| Term (SR) | |
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| Definition (SR) | |
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| Date | 2025-01-13 |
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| Standards | BAS EN ISO 15189:2025 |
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