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ISO 15197:2013

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
14. 5. 2013.

Опште информације

90.92     19. 12. 2024.

ISO

ISO/TC 212

Međunarodni standard

11.100.10  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.

Životni ciklus

PRETHODNO

POVUČEN
ISO 15197:2003

TRENUTNO

OBJAVLJEN
ISO 15197:2013
90.92 Odluka o izmeni ili reviziji standarda
19. 12. 2024.

REVIDIRAN OD

NAPUŠTEN
ISO/NP 15197

PROJEKAT
ISO/AWI 15197

Nacionalna preuzimanja

SRPS EN ISO 15197:2017  
ISS

Sistemi ispitivanja za dijagnostiku in vitro – Zahtevi za sisteme praćenja glukoze u krvi za samotestiranje u kontrolisanju dijabetes melitusa

60.60   Standard objavljen

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