NF EN ISO 14155-2

NF EN ISO 14155-2

July 2003
Standard Cancelled

Clinical investigation of medical devices for human subjects - Part 2 : Clinical investigation plans

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the 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.This Standard does not apply to in vitro diagnostic medical devices.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

July 2003

Number of pages

15 p.

Reference

NF EN ISO 14155-2

ICS Codes

03.120.10   Quality management and quality assurance
11.100.99   Other standards related to laboratory medicine

Classification index

S99-201-2

Print number

1 - 28/10/2003

International kinship

ISO 14155-2:2003

European kinship

EN ISO 14155-2:2003
Sumary
Clinical investigation of medical devices for human subjects - Part 2 : Clinical investigation plans

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the 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.

This Standard does not apply to in vitro diagnostic medical devices.

Standard replaced by (1)
NF EN ISO 14155-2
November 2009
Standard Cancelled
Clinical investigation of medical devices for human subjects - Part 2 : clinical investigation plans

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the 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. This Standard does not apply to in vitro diagnostic medical devices.

Table of contents
  • Avant-propos
    3
  • Introduction
    4
  • 1
    Domaine d'application 4
  • 2
    Référence normative 4
  • 3
    Termes et définitions 4
  • 4
    Exigences 5
  • 4.1
    Généralités 5
  • 4.2
    Plan d'investigation clinique (PIC) 5
  • 4.3
    Informations générales 5
  • 4.4
    Identification et description du dispositif médical soumis à l'investigation 6
  • 4.5
    Investigations préliminaires et justification de l'étude 6
  • 4.6
    Objectifs de l'investigation clinique 7
  • 4.7
    Conception de l'investigation clinique 8
  • 4.8
    Considérations statistiques 9
  • 4.9
    Écarts par rapport au plan d'investigation clinique 9
  • 4.10 Amendements au plan d'investigation clinique
    9
  • 4.11 Événements indésirables et effets indésirables du dispositif
    9
  • 4.12 Interruption anticipée ou suspension de l'investigation
    10
  • 4.13 Politique en matière de publication
    10
  • 4.14 Formulaire de rapport de cas
    10
  • Annexe A (informative) Formulaires de rapport de cas
    11
  • Annexe ZA (informative) Articles de la présente Norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    12
  • Bibliographie
    13
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