NF EN ISO 14155-2 : 2009
Superseded
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
01-12-2013
03-01-2011
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)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Superseded
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| Standards | Relationship |
| DIN EN ISO 14155-2:2003-09 | Identical |
| I.S. EN ISO 14155-2:2009 | Identical |
| ISO 14155-2:2003 | Identical |
| UNE-EN ISO 14155-2:2009 | Identical |
| BS EN ISO 14155-2:2009 | Identical |
| DIN EN ISO 14155-2:2009-11 | Identical |
| EN ISO 14155-2:2009 | Identical |