NF EN ISO 15197

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.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2015

Number of pages

56 p.

Reference

NF EN ISO 15197

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-026

Print number

1

International kinship

ISO 15197:2013

European kinship

EN ISO 15197:2015
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
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
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Conception et développement
  • 5 Essais pour la sécurité et la fiabilité
  • 6 Évaluation des performances analytiques
  • 7 Notice d'information du fabricant
  • 8 Évaluation des performances de l'utilisateur
  • Annexe A(informative)Substances potentiellement interférentes
  • Annexe B(informative)Chaîne de traçabilité
  • Annexe C(informative)Justification des critères de performance analytique
  • Annexe ZA(informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 98/79/CE
  • Bibliographie
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