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CEI UNI EN ISO 14971

CEI Classification: 62-121

Dispositivi medici
Applicazione della gestione dei rischi ai dispositivi medici (ISO 14971:2000)
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Publication Date: 2002-05
Date Of Withdrawal (DOW): 2006-03
ValidFrom: 2002-05
Language: IT
Pages: 44
Issue Num.:  6485
Commitee: CEI-SC62A, CEI-CT62
shopping_cart Starting from € 28.00
La norma specifica una procedura che permette di identificare i pericoli associati ai dispositivi medici e ai loro accessori, inclusi i dispositivi medico-diagnostici in vitro.
La norma permette di stimare e valutare i rischi, di controllare tali rischi e di monitorare l’efficacia del controllo.
La norma si applica a tutte le fasi del ciclo di vita di un dispositivo medico.
La norma non si applica ai giudizi clinici relativi all’uso di un dispositivo medico, né specifica i livelli di rischio accettabili.
La norma esce congiunta CEN/CENELEC e quindi CEI UNI perché riguarda tutti i dispositivi medici ad alimentazione elettrica e non-elettrica. La norma EN 1441:1997 che abroga è solo UNI.

See also

EN ISO 14971:2000
EN ISO 14971 Ec:2002
ISO/IEC 14971:2000

International Coding Standard (ICS)

11.040.01
Medical equipment in general

Annotation

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ICS

International Classification for Standards (ICS) is an international classification system for technical standards.

The ICS is a hierarchical classification organized on three levels.

Level 1 covers the main fields of activity in standardization, e.g. road vehicle engineering, agriculture, metallurgy.

Each field has a two-digit notation, e.g.

  43    Road Vehicle Engineering

The main fields are subdivided into groups (level 2). The notation of a group consists of the field notation and a three-digit group number, separated by a point, e.g.

  43.040    Road vehicle systems

Some groups are further divided into sub-groups (level 3). The notation of a sub-group consists of the group notation and a two-digit number, separated by a point, e.g.

  43.040.20 Lighting, signaling and warning devices

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