SSH EN ISO 15197:2015

Sistemet e provës të diagnostikimit in vitro - Kërkesat për sistemet e monitorimit të glukozës së gjakut për vet testim në menaxhimin e diabetit mellitus (Diabet i Tipit 1) (ISO 15197:2013)

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

Publication date: 31 mar 2016

General information

Current stage: 60.60 Effective date: 31 mar 2016

Originator: DPS

Owner: DPS/KT 140

Type: European Norm

ICS: 11.100.10

Gjuha: anglisht

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Statusi: Publikuar

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Scope

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.

Related directives

Directives related to this standards.

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara

më tepër

Life cycle

PREVIOUSLY

Replaces
SSH EN ISO 15197:2013

NOW

PUBLISHED
SSH EN ISO 15197:2015
60.60 Standard published
31 mar 2016

Related project

Adopted from EN ISO 15197:2015

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