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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: 2013-05
Date Of Withdrawal (DOW): 2020-03
ValidFrom: 2012-10
ValidTo: 2020-06
Language: IT
Pages: 98
Issue Num.:  12929
Commitee: CEI-SC62A, CEI-CT62
La Norma specifica una procedura che permette al fabbricante di identificare i pericoli associati ai dispositivi medici, inclusi i dispositivi medico-diagnostici in vitro, 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. La Norma non si applica al processo decisionale clinico e non specifica i livelli di rischio accettabili.
La Norma in oggetto sostituisce completamente la Norma CEI UNI EN ISO 14971:2009-10.
La presente Norma riporta il testo in inglese e italiano della EN ISO 14971; rispetto al precedente fascicolo n. 12247E di ottobre 2012, essa contiene la traduzione completa della EN sopra indicata.
.Gli acquirenti della presente Norma riceveranno gratuitamente la versione bilingue in formato PDF, o in alternativa potranno acquistare la versione bilingue in formato cartaceo, usufruendo del 70 % di sconto.
La presente Norma é annullata e sostituita dalla Nuova edizione, CEI UNI EN ISO 14971:2020-02 (CEI UNI 62-121, tuttavia rimane applicabile fino al 30-06-2020.

See also

EN ISO 14971:2012
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

You can identify the ICS code of your interest by typing the code or a keywordword in the dropdown ICS field, and by selecting one of the filtered results.

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You should use this option when you can not find the desired result with the standard approach and it is necessary to extend the scope of the search: by increasing the number of results, you will increase the number of non-relevant elements, as well.