NF EN ISO 14155-1

Afnor EDITIONS
Standards
NF EN ISO 14155-1

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.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

October 2003

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 - 24/12/2003

International kinship

ISO 14155-1:2003

European kinship

EN ISO 14155-1:2003

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

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.

Replaced standards (1)

NF EN 540

October 1993

Standard Cancelled

Clinical investigation of medical devices for human subjects.

Le présent document constitue une aide pour les fabricants, autorités de réglementation et investigateurs, pour conduire les investigations cliniques des dispositifs médicaux, avant leur commercialisation.

Standard replaced by (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: <ul><li>protect human subjects;</li><li>ensure the scientific conduct of the clinical investigation;</li><li>assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.</li></ul> ISO 14155-1:2002 <ol><li>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,</li><li>specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,</li><li>is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.</li></ol> ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

Table of contents

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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 Accords) 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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