HRN EN ISO 15197:2015
Dijagnostički sustavi ispitivanja in vitro -- Zahtjevi za sustave praćenja glukoze u krvi za samoispitivanje šećerne bolesti (ISO 15197:2013; EN ISO 15197:2015)
| Oznaka: | HRN EN ISO 15197:2015 |
| Naslov (HR): | Dijagnostički sustavi ispitivanja in vitro -- Zahtjevi za sustave praćenja glukoze u krvi za samoispitivanje šećerne bolesti (ISO 15197:2013; EN ISO 15197:2015) |
| Naslov (EN): | In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013; EN ISO 15197:2015) |
| Područje primjene (EN): | 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. |
| Izdanje: | 3 |
| ICS: | 11.100.10 In vitro dijagnostički ispitni sustavi |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (objava): | HZN e-Glasilo 6/2015 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 50,00 € | Jezik: en | Cjenovni razred: J | Broj stranica: 52 |
| Izvornik: | EN ISO 15197:2015 |
| Zamjenjuje: | HRN EN ISO 15197:2013 |
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