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CEI EN 62304/A1

CEI Classification: 62-140;V1

Software per dispositivi medici - Processi relativi al ciclo di vita del software
standard
CEI
CEI
Standard
Amendment help_outline
Publication Date: 2016-04
ValidFrom: 2016-05
Language: EN
Pages: 50
Issue Num.:  14835 E
Commitee: CEI-SC62A, CEI-CT62
shopping_cart Starting from € 80.00
Questo documento ha lo scopo di aggiungere i requisiti per affrontare gli aspetti legali del software, nel caso di software sviluppati precedentemente alla versione attuale, per assistere i produttori che devono dimostrare la conformità alla Norma al fine di soddisfare le Direttive Europee. Le modifiche alla classificazione di sicurezza del software comprendono il chiarimento dei requisiti e l'aggiornamento della classificazione di sicurezza del software per includere l'approccio basato sul rischio.


Questa Variante viene pubblicata dal CEI nella sola lingua inglese in quanto particolarmente mirata a settori specialistici.
La presente Variante recepisce il testo originale inglese della Pubblicazione IEC.

Relations

Amends: CEI EN 62304

See also

EN 62304/A1:2015
IEC 62304/A1:2015

International Coding Standard (ICS)

11.040.01
Medical equipment in general
11.040
Medical equipment

Annotation

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Standard Evolution

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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.

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.