NF EN ISO 14155-2

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.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

November 2009

Number of pages

16 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 - 16/12/2009

International kinship

ISO 14155-2:2003

European kinship

EN ISO 14155-2:2009
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.

Replaced standards (1)
NF EN ISO 14155-2
July 2003
Standard Cancelled
Clinical investigation of medical devices for human subjects - Part 2 : Clinical investigation plans

Le présent document complète la NF EN ISO 14155-1, en préparation, sur les investigations cliniques des dispositifs médicaux (à l'exception de ceux pour le diagnostic in vitro) en détaillant le plan d'investigation clinique.

Standard replaced by (1)
NF EN ISO 14155
March 2011
Standard Cancelled
Clinical investigation of medical devices for human subjects - Good clinical practice

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations. ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. ISO 14155:2011 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) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE relative aux dispositifs médicaux
    12
  • 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
    13
  • Bibliographie
    14
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