NF EN ISO 14155-2 : 2009

Superseded

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS

Superseded date

03-01-2011

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

Avant-propos
Introduction
1 Domaine d'application
2 Référence normative
3 Termes et définitions
4 Exigences
Annexe A (informative) - Formulaires de rapport de cas
Annexe ZA (informative) - Relation entre la présente Norme
          européenne et les exigences essentielles de la
          Directive européenne 93/42/CEE relative aux
          dispositifs médicaux
Annexe ZB (informative) - Relation entre la présente Norme
          européenne et les exigences essentielles de la
          Directive européenne 90/385/CEE relative aux
          dispositifs médicaux implantables actifs
Bibliographie

Gives requirements for the preparation of a Clinical Investigation Plan (CIP) for clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.

DevelopmentNote	Indice de classement: S99-201-2. (07/2003) PR NF EN ISO 14155-2 May 2009. (05/2009) 2003 version is still active. (02/2010)
DocumentType	Standard
PublisherName	Association Francaise de Normalisation
Status	Superseded

Standards	Relationship
DIN EN ISO 14155-2:2003-09	Identical
I.S. EN ISO 14155-2:2009	Identical
ISO 14155-2:2003	Identical
BS EN ISO 14155-2:2009	Identical
UNI EN ISO 14155-2 : 2009	Identical
UNE-EN ISO 14155-2:2009	Identical
DIN EN ISO 14155-2:2009-11	Identical
EN ISO 14155-2:2009	Identical

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