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NF EN 13612 : 2002

Current
Current

The latest, up-to-date edition.

PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Published date

01-12-2013

Avant-propos
Introduction
1 Domaine d'application
2 Termes et définitions
3 Exigences générales relatives à l'évaluation des
  performances
  3.1 Responsabilité et ressources
  3.2 Documentation
  3.3 Évaluation finale et revue
4 Organisation d'une étude d'évaluation des performances
  4.1 Conditions préalables
  4.2 Plan d'évaluation
  4.3 Sites et ressources
  4.4 Informations fondamentales relatives à la conception
  4.5 Conception expérimentale
  4.6 Enregistrements des études de performances
  4.7 Observations et résultats inattendus
  4.8 Rapport d'évaluation
5 Modifications pendant l'étude d'évaluation des performances
6 Réévaluation
7 Protection et sécurité des sujets
Annexe ZA (informative) Articles de la présente norme
                        européenne concernant les
                        exigences essentielles ou d'autres
                        dispositions des Directives UE
Bibliographie

Specifies performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. Also defines the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer.

DevelopmentNote
Indice de classement: S92-025. Supersedes NFS 92 025 (03/2004)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current
Supersedes

Standards Relationship
EN 13612:2002/AC:2002 Identical
UNE-EN 13612:2002 Identical
UNI EN 13612 : 2002 Identical
DIN EN 13612:2002-08 Identical
BS EN 13612:2002 Identical

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