| Standardization field | Health, environment and medical equipment |
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| Technical committee | BAS/TC 25- Healthcare |
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| Term (EN) | validation |
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| Definition (EN) | confirmation of plausibility for a specific intended use or application through the provision of objective evidence that specified requirements have been fulfilled
Note 1 to entry: Objective evidence can be obtained through observation, measurement, examination or by other means.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: Specified requirements of an examination method may include the following performance specifications: measurement trueness, measurement precision including measurement repeatability, and measurement intermediate precision, analytical specificity, including interfering substances, detection limit and quantitation limit, measuring interval, clinical relevance, diagnostic specificity and diagnostic sensitivity.
[SOURCE: ISO/IEC 17000:2020, 6.5, modified — Notes 1 to 3 to entry have been added.] |
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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) | validacija |
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| Definition (BS) | potvrđivanje vjerodostojnosti za specifičnu namjenu ili primjenu prikupljanjem objektivnih dokaza da su specificirani zahtjevi ispunjeni
Napomena 1: Objektivni dokazi mogu biti dobijeni kroz posmatranje, mjerenje, ispitivanje ili na druge načine.
Napomena 2: Riječ “validiran” koristi se da označi odgovarajući status.
Napomena 3: Specificirani zahtjevi za metodu ispitivanja mogu uključivati sljedeće specifikacije performansi: istinitost mjerenja, preciznost mjerenja uključujući ponovljivost, i intermedijarnu mjernu preciznost, analitičku specifičnost, uključujući interferirajuće supstance, limit detekcije i limit kvantifikacije, mjerni interval, kliničku relevantnost, dijagnostičku specifičnost i dijagnostičku osjetljivost.
[IZVOR: ISO/IEC 17000:2020, 6.5, modificirana — Napomene od 1 do 3 su dodane.] |
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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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