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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

General information

Valid from 14.05.2013
ICS Groups
11.100.10 In vitro diagnostic test systems
Directives or regulations
None

Standard history

Status
Date
Type
Name
14.05.2013
Main
ISO 15197:2013
Main
ISO 15197:2003
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.

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Standard monitoring
English (PDF 790 KB)

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EVS-EN ISO 18113-1:2011

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Withdrawn from 15.07.2024
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EVS-EN ISO 23640:2015

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EVS-EN ISO 18113-2:2011

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EVS-EN ISO 18113-3:2011

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Withdrawn from 01.07.2024

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English