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CEI UNI EN ISO 14971

CEI Classification: 62-121

Dispositivi medici - Applicazione della gestione dei rischi ai dispositivi medici
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Publication Date: 2009-10
Date Of Withdrawal (DOW): 2012-11
ValidFrom: 2009-09
ValidTo: 2013-01
Language: IT
Pages: 88
Issue Num.:  10036
Commitee: CEI-SC62A, CEI-CT62
La presente Norma specifica la procedura che permette di identificare i pericoli associati ai dispositivi medici ed ai loro accessori, inclusi i dispositivi medico-diagnostici in vitro.
Essa permette di stimare e valutare i rischi, di controllare tali rischi e di monitorare l’efficacia del controllo.
La presente Norma si applica a tutte le fasi del ciclo di vita di un dispositivo medico; essa non si applica ai giudizi clinici relativi all’uso di un dispositivo medico, né specifica i livelli di rischio accettabili.
La presente Norma riporta la traduzione della EN ISO 14971 pubblicata a settembre 2009 nella versione originale inglese (fascicolo n. 9954E); essa comprende solo la versione italiana della EN ISO sopra indicata.
La presente Norma é annullata e sostituita dalla Nuova edizione, CEI UNI EN ISO 14971:2012-10 (CEI UNI 62-121), tuttavia rimane applicabile fino al 31-01-2013.

See also

EN ISO 14971:2009
ISO 14971:2007

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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