NF EN ISO 15197

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).

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Main informations

Collections

National standards and national normative documents

Publication date

June 2004

Number of pages

48 p.

Reference

NF EN ISO 15197

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-026

Print number

2 - 01/04/2005

International kinship

ISO 15197:2003

European kinship

EN ISO 15197:2003
Sumary
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
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.

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
    6
  • 4.1 Exigences générales
    6
  • 4.2 Sécurité
    6
  • 4.3 Traçabilité
    7
  • 4.4 Aspects ergonomiques et liés aux facteurs humains
    7
  • 4.5 Analyse des risques
    7
  • 4.6 Vérification par l'utilisateur
    8
  • 5 Informations fournies par le fabricant
    8
  • 5.1 Étiquette du lecteur de glycémie
    8
  • 5.2 Mode d'emploi du système de surveillance de la glycémie
    8
  • 5.3 Étiquettes relatives au système de réactifs et aux matériaux de contrôle
    10
  • 5.4 Mode d'emploi relatif aux réactifs et aux matériaux de contrôle
    10
  • 6 Sécurité et essais de contrôle de la fiabilité
    11
  • 6.1 Exigences générales
    11
  • 6.2 Protection contre le choc électrique
    12
  • 6.3 Protection contre les risques mécaniques
    12
  • 6.4 Compatibilité électromagnétique
    12
  • 6.5 Résistance à la chaleur
    12
  • 6.6 Résistance à l'humidité et aux liquides
    12
  • 6.7 Protection contre les gaz libérés, l'explosion et l'implosion
    12
  • 6.8 Composants du lecteur
    12
  • 6.9 Évaluation des performances
    12
  • 6.10 Résistance mécanique aux chocs, vibrations et impacts
    13
  • 6.11 Limites d'exposition à la température de l'équipement
    13
  • 6.12 Protocole d'essai d'exposition à l'humidité de l'équipement
    14
  • 6.13 Conditions de stockage et d'utilisation des réactifs
    14
  • 7 Évaluation des performances analytiques
    14
  • 7.1 Exigences générales
    14
  • 7.2 Évaluation de la fidélité
    15
  • 7.3 Évaluation de l'exactitude du système
    19
  • 7.4 Exactitude minimale acceptable du système
    26
  • 8 Évaluation des performances de l'utilisateur
    27
  • 8.1 Généralités
    27
  • 8.2 Sites d'évaluation
    27
  • 8.3 Évaluation de l'utilisateur
    28
  • 8.4 Évaluation du mode d'emploi
    28
  • Annexe A (normative) Exigences supplémentaires relatives à la compatibilité électromagnétique
    29
  • Annexe B (informative) Chaîne de traçabilité
    31
  • Bibliographie
    32
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