NF EN ISO 14971

NF EN ISO 14971

November 2009
Standard Cancelled

Medical devices - Application of risk management to medical devices

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

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Collections

National standards and national normative documents

Publication date

November 2009

Number of pages

100 p.

Reference

NF EN ISO 14971

ICS Codes

11.040.01   Medical equipment in general

Classification index

S99-211

Print number

1 - 16/10/2009

International kinship

ISO 14971:2007

European kinship

EN ISO 14971:2009
Sumary
Medical devices - Application of risk management to medical devices

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Replaced standards (1)
NF EN ISO 14971
June 2007
Standard Cancelled
Medical devices - Application of risk management to medical devices

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Standard replaced by (1)
NF EN ISO 14971
January 2013
Standard Cancelled
Medical devices - Application of risk management to medical devices

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Table of contents
  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Termes et définitions
    1
  • 3 Exigences générales relatives à la gestion des risques
    5
  • 3.1 Processus de gestion des risques
    5
  • 3.2 Responsabilités de la direction
    7
  • 3.3 Qualification du personnel
    8
  • 3.4 Plan de gestion des risques
    8
  • 3.5 Dossier de gestion des risques
    9
  • 4 Analyse du risque
    9
  • 4.1 Processus d'analyse du risque
    9
  • 4.2 Emploi prévu et identification des caractéristiques relatives à la sécurité du dispositif médical
    10
  • 4.3 Identification des phénomènes dangereux
    10
  • 4.4 Estimation du ou des risques pour chaque situation dangereuse
    11
  • 5 Évaluation du risque
    11
  • 6 Maîtrise du risque
    12
  • 6.1 Réduction du risque
    12
  • 6.2 Analyse d'option de maîtrise du risque
    12
  • 6.3 Mise en oeuvre de la ou des mesures de maîtrise du risque
    12
  • 6.4 Évaluation des risques résiduels
    13
  • 6.5 Analyse du rapport bénéfice/risque
    13
  • 6.6 Risques découlant des mesures de maîtrise du risque
    13
  • 6.7 Maîtrise complète des risques
    14
  • 7 Évaluation de l'acceptabilité du risque résiduel global
    14
  • 8 Rapport de gestion des risques
    14
  • 9 Informations de production et de postproduction
    15
  • Annexe A (informative) Justification des exigences
    16
  • Annexe B (informative) Vue générale du processus de gestion des risques des dispositifs médicaux
    25
  • Annexe C (informative) Questions pouvant être utilisées pour identifier les caractéristiques des dispositifs médicaux ayant une influence potentielle sur la sécurité
    27
  • Annexe D (informative) Concepts de risques appliqués aux dispositifs médicaux
    34
  • Annexe E (informative) Exemples de phénomènes dangereux, séquences d'événements prévisibles et situations dangereuses
    53
  • Annexe F (informative) Plan de gestion des risques
    59
  • Annexe G (informative) Informations sur les techniques de gestion des risques
    61
  • Annexe H (informative) Lignes directrices sur la gestion des risques liés aux dispositifs médicaux de diagnostic in vitro
    65
  • Annexe I (informative) Lignes directrices relatives au processus d'analyse des phénomènes dangereux biologiques
    82
  • Annexe J (informative) Informations relatives à la sécurité et au risque résiduel
    84
  • Bibliographie
    86
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