NF EN 12286

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.

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Main informations

Collections

National standards and national normative documents

Publication date

March 1999

Number of pages

24 p.

Reference

NF EN 12286

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-019

Print number

1 - 06/10/2004

European kinship

EN 12286:1998
Sumary
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.
Standard replaced by (1)
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

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

Table of contents
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  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Termes et définitions
    5
  • 4 Présentation d'un mode opératoire de mesure de référence
    6
  • Annexe A (informative) Modes opératoires de référence pour les propriétés autres que les grandeurs
    20
  • Annexe B (informative) Bibliographie
    21
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