NF EN ISO 18113-1

NF EN ISO 18113-1

March 2010
Standard Cancelled

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2010

Number of pages

60 p.

Reference

NF EN ISO 18113-1

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-010-1

Print number

1 - 11/03/2010

International kinship

ISO 18113-1:2009

European kinship

EN ISO 18113-1:2009
Sumary
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

Standard replaced by (1)
NF EN ISO 18113-1
May 2012
Standard Current
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences générales relatives aux informations fournies par le fabricant
    18
  • 4.1 Généralités
    18
  • 4.2 Langue
    19
  • 4.3 Symboles et couleurs d'identification
    19
  • 4.4 Valeurs et nomenclature
    19
  • 4.5 Charge microbienne
    19
  • 4.6 Notices d'utilisation
    19
  • 4.7 Modifications apportées au dispositif médical de DIV
    20
  • 4.8 Présentation des risques résiduels
    20
  • 4.9 Identification des composants
    20
  • 4.10 Assistance
    21
  • Annexe A (informative) Caractéristiques de performance des dispositifs médicaux de DIV
    22
  • Bibliographie
    46
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