NF EN ISO 14155-1

NF EN ISO 14155-1

November 2009
Standard Cancelled

Clinical investigation of medical devices for human subjects - Part 1 : general requirements

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:protect human subjects;ensure the scientific conduct of the clinical investigation;assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.ISO 14155-1:2002specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.ISO 14155-1:2002 is not applicable 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

34 p.

Reference

NF EN ISO 14155-1

ICS Codes

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

Classification index

S99-201-1

Print number

1 - 03/11/2009

International kinship

ISO 14155-1:2003

European kinship

EN ISO 14155-1:2009
Sumary
Clinical investigation of medical devices for human subjects - Part 1 : general requirements

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:

  • protect human subjects;
  • ensure the scientific conduct of the clinical investigation;
  • assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.

ISO 14155-1:2002

  1. specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,
  2. specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,
  3. is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.

ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

Replaced standards (1)
NF EN ISO 14155-1
October 2003
Standard Cancelled
Clinical investigation of medical devices for human subjects - Part 1 : general requirements

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to: protect human subjects;ensure the scientific conduct of the clinical investigation;assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. ISO 14155-1:2002 specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

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
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Justification d'une investigation clinique
    5
  • 5 Considérations éthiques
    5
  • 5.1 Déclaration d'Helsinki
    5
  • 5.2 Influence ou incitation abusives
    5
  • 5.3 Compensation et soins de santé supplémentaires
    5
  • 5.4 Responsabilités
    5
  • 6 Exigences générales
    5
  • 6.1 Accord(s) formel(s)
    5
  • 6.2 Qualifications
    6
  • 6.3 Plan d'investigation clinique
    6
  • 6.4 Conception de l'investigation clinique
    6
  • 6.5 Confidentialité
    6
  • 6.6 Début de l'investigation clinique
    6
  • 6.7 Consentement éclairé
    6
  • 6.8 Suspension ou interruption anticipée de l'investigation clinique
    8
  • 6.9 Maîtrise des documents et des données
    9
  • 6.10 Prise en compte des sujets
    9
  • 6.11 Accès aux informations précliniques et cliniques
    9
  • 6.12 Audit
    9
  • 7 Documentation
    9
  • 7.1 Généralités
    9
  • 7.2 Notice de l'investigateur clinique
    9
  • 7.3 Autres documents
    10
  • 8 Promoteur
    10
  • 8.1 Généralités
    10
  • 8.2 Responsabilités du promoteur
    10
  • 9 Moniteur
    12
  • 9.1 Responsabilités du moniteur
    12
  • 10 Investigateur clinique
    12
  • 10.1 Généralités
    12
  • 10.2 Qualification de l'investigateur clinique
    12
  • 10.3 Responsabilités de l'investigateur clinique
    13
  • 11 Rapport final
    14
  • 11.1 Présentation des résultats
    14
  • 11.2 Contenu du rapport final
    14
  • Annexe A (informative) Mode opératoire proposé pour la revue de la littérature scientifique
    16
  • Annexe B (informative) Information pour les comités d'éthique
    19
  • Annexe C (informative) Rapports finaux d'investigations cliniques sur les dispositifs médicaux
    20
  • Bibliographie
    24
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