SK EN ISO 15197:2017

Status: Published
Gjuha: English
Faqe: 53
Publikuar: 2017-12-01
Regjistri Kombëtar: 213/2017
Botim:

Standardet ndërkombëtare që kanë lidhje

This standard is identical to:
EN ISO 15197:2015
CEN/TC 140

This standard is identical to:
ISO 15197:2013
ISO/TC 212

Çmim: 38 €

Titulli Shqip

Sistemet e provave të diagnostikimit in vitro -Kërkesat për sistemet e monitorimit të glukozës së gjakut për vet testim në menagjimin e diabetit

Titulli Anglisht

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

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.