NF EN ISO 15193

NF EN ISO 15193

October 2009
Standard Current

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2009

Number of pages

31 p.

Reference

NF EN ISO 15193

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-019

Print number

1 - 19/11/2009

International kinship

ISO 15193:2009

European kinship

EN ISO 15193:2009
Sumary
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

Replaced standards (2)
NF EN 12286
March 1999
Standard Cancelled
In vitro medical devices. Measurements of quantities in samples of biological origin. Presentation of reference measurement procedures.

Le présent document spécifie les prescriptions relatives à la rédaction d'un mode opératoire de mesure de référence.

NF EN 12286/A1
October 2000
Standard Cancelled
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

Le présent amendement à l'EN 12286 vise à conférer à cette norme européenne le statut de norme harmonisée.

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Présentation d'une procédure de mesure de référence
    4
  • 4.1 Éléments d'une procédure de mesure de référence écrite
    4
  • 4.2 Avertissement et précautions de sécurité
    4
  • 4.3 Introduction
    5
  • 4.4 Domaine d'application
    5
  • 4.5 Termes, définitions, symboles et abréviations
    5
  • 4.6 Principe de mesure et méthode de mesure
    6
  • 4.7 Liste de contrôle
    6
  • 4.8 Réactifs et matériaux
    7
  • 4.9 Appareillage
    9
  • 4.10 Échantillonnage et échantillon
    9
  • 4.11 Préparation du système de mesure et de la prise d'essai pour analyse
    9
  • 4.12 Utilisation du système de mesure
    11
  • 4.13 Traitement des données
    12
  • 4.14 Fiabilité analytique
    12
  • 4.15 Cas particuliers
    15
  • 4.16 Validation d'une procédure de mesure de référence
    15
  • 4.17 Rapport
    16
  • 4.18 Assurance de la qualité
    16
  • 4.19 Bibliographie
    16
  • 4.20 Dates d'autorisation et de révision
    17
  • Annexe A (informative) Procédures de référence pour les propriétés autres que les grandeurs différentielles et proportionnelles
    18
  • Bibliographie
    20
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