UNI CEI EN ISO 14971:2020 | Dispositivi medici Gestione dei rischi

UNI CEI EN ISO 14971:2020 | Dispositivi medici Gestione dei rischi 

UNI CEI EN ISO 14971:2020 Dispositivi medici - Applicazione della gestione dei rischi ai dispositivi medici

Data entrata in vigore : 23 gennaio 2020

La norma specifica la terminologia, i principi ed un processo di gestione dei rischi relativo a dispositivi medici, incluso il software utilizzato come dispositivo medico e i dispositivi medico-diagnostici in vitro.

Il processo descritto nella norma intende aiutare i fabbricanti di dispositivi medici ad identificare i pericoli associati ai dispositivi medici, per stimare e valutare i rischi associati, per controllare tali rischi, e per monitorare l'efficacia dei controlli.

I requisiti della norma sono applicabili a tutte le fasi del ciclo di vita di un dispositivo medico.

Recepisce: CEN11063920

Adotta: ISO 14971:2019

Sostituisce: UNI CEI EN ISO 14971:2012

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In allegato preview ISO 14971:2019 riservata abbonati

ISO 14971:2019 Medical devices - Application of risk management to medical devices

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.

This document does not apply to:

- decisions on the use of a medical device in the context of any particular clinical procedure; or

- business risk management.

This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.

Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.

NOTE Guidance on the application of this document can be found in ISO/TR 24971.

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Fonte: ISO/UNI

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