NF EN ISO 15197

NF EN ISO 15197

July 2013
Standard Cancelled

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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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Main informations

Collections

National standards and national normative documents

Publication date

July 2013

Number of pages

60 p.

Reference

NF EN ISO 15197

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-026

Print number

1 - 15/07/2013

International kinship

ISO 15197:2013

European kinship

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

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.

Replaced standards (1)
NF EN ISO 15197
June 2004
Standard Cancelled
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

ISO 15197:2003 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus. ISO 15197:2003 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. ISO 15197:2003 does not provide a comprehensive evaluation of all possible factors that could affect the performance of these systems; does not pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus; does not address the medical aspects of diabetes mellitus management; does not apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

Standard replaced by (1)
NF EN ISO 15197
December 2015
Standard Current
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Conception et développement
    8
  • 4.1 Exigences générales
    8
  • 4.2 Traçabilité métrologique
    8
  • 4.3 Sécurité et gestion des risques
    9
  • 4.4 Ergonomie et facteurs humains
    10
  • 4.5 Exigences relatives aux vérifications par l'utilisateur
    10
  • 5 Essais pour la sécurité et la fiabilité
    11
  • 5.1 Exigences générales
    11
  • 5.2 Protection contre les chocs électriques
    11
  • 5.3 Protection contre les risques mécaniques
    11
  • 5.4 Compatibilité Électromagnétique
    12
  • 5.5 Résistance à la chaleur
    12
  • 5.6 Résistance à l'humidité et aux liquides
    12
  • 5.7 Protection contre les gaz libérés, l'explosion et l'implosion
    12
  • 5.8 Composants du lecteur
    12
  • 5.9 Essai de performance
    12
  • 5.10 Résistance mécanique aux vibrations et chocs
    13
  • 5.11 Limites de température pour le stockage
    13
  • 5.12 Limites d'humidité pour le stockage de l'équipement
    14
  • 6 Évaluation des performances analytiques
    14
  • 6.1 Exigences générales
    14
  • 6.2 Fidélité de mesure
    16
  • 6.3 Exactitude du système
    20
  • 6.4 Grandeurs d'influence
    27
  • 6.5 Stabilité des réactifs et matériaux
    32
  • 7 Notice d'information du fabricant
    32
  • 7.1 Exigences générales
    32
  • 7.2 Caractéristiques de performance
    32
  • 7.3 Options de fourniture des instructions d'utilisation
    32
  • 8 Évaluation des performances de l'utilisateur
    33
  • 8.1 Exigences générales
    33
  • 8.2 Critères d'acceptation et évaluation des résultats
    33
  • 8.3 Sélection et préparation des sujets
    33
  • 8.4 Exécution du protocole de l'étude
    34
  • 8.5 Concentrations en glucose de référence
    34
  • 8.6 Facteurs humains
    35
  • 8.7 Analyse des données et présentation des résultats
    35
  • 8.8 Évaluation du mode d'emploi
    36
  • Annexe A (informative) Substances potentiellement interférentes
    37
  • Annexe B (informative) Chaîne de traçabilité
    38
  • Annexe C (informative) Justification des critères de performance analytique
    40
  • Bibliographie
    47
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