torna su
close Close

CEI membership discount

Dear customer,
our systems show that your name is connected to a company associated with CEI: you would therefore be entitled to thediscount reserved for our members for CEI products and services. To check the validity of the association and benefit from the discounts, it is necessary to enter the register number assigned to your company in the box below.

VALIDATE AND CONTINUE
You can continue shopping even without entering the membership register number, but you will not have access to dedicated discounts.

CONTINUE WITHOUT DISCOUNTS

The membership register number has been correctly entered.
From now on, after logging into your MyNorma account, you can purchase our products at the price reserved for our members.

doneCONTINUE PURCHASING
Replaced help_outline
mode_commenti add_alert notifications star_border star

CEI UNI EN ISO 14971

CEI Classification: 62-121

Dispositivi medici - Applicazione della gestione dei rischi ai dispositivi medici
standard
CEI
CEI
Standard help_outline
Publication Date: 2012-10
Date Of Withdrawal (DOW): 2020-03
ValidFrom: 2012-10
ValidTo: 2020-06
Language: EN
Pages: 108
Issue Num.:  12247 E
Commitee: CEI-SC62A, CEI-CT62
shopping_cart Starting from € 70.00
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, che rimane applicabile fino al 31-01-2013.
Questa Norma viene pubblicata dal CEI in una prima fase nella sola lingua inglese, per consentirne l'immediato utilizzo da parte degli utenti interessati, nel rispetto della data di pubblicazione fissata dagli Enti Normatori internazionali.
Successivamente il CEI pubblicherà, in un nuovo fascicolo, la stessa Norma in versione italiano-inglese; tale nuova versione avrà la stessa validità della presente.
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.

Relations

Replaces: CEI UNI EN ISO 14971
Replaces: CEI UNI EN ISO 14971

See also

ISO 14971:2007
EN ISO 14971:2012

International Coding Standard (ICS)

11.040.01
Medical equipment in general

Annotation

PLEASE NOTE: links will be automatically recognized and made clickable when the annotation will be published

send

Standard Evolution

close

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.

Search also in the summary/description of the standard

By flagging this control, the search for keywords will not be limited to the Standard Number and Title fields, but will also be performed in the Abstract of the standard.

This way, you will get more results.

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.