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CEI EN 62366-1

CEI Classification: 62-243

Dispositivi medici
Parte 1: Applicazione dell'ingegneria delle caratteristiche utilizzative ai dispositivi medici
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CEI
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Publication Date: 2016-04
ValidFrom: 2016-05
Language: EN
Pages: 58
Issue Num.:  14836 E
Commitee: CEI-SC62A, CEI-CT62
Questa Parte della EN 62366 specifica un processo per il produttore per analizzare, specificare, sviluppare e valutare l'usabilità di un dispositivo medico in relazione alla sicurezza.
Questo processo di "usability engineering" consente al produttore di valutare e mitigare i rischi connessi con un uso corretto e gli errori d'utilizzo.
Il documento può essere utilizzato per identificare, ma non valutare e mitigare i rischi associati all'uso anomalo.

Questa Norma viene pubblicata dal CEI nella sola lingua inglese in quanto particolarmente mirata a settori specialistici.
La presente Norma recepisce il testo originale inglese della Pubblicazione IEC.
La Norma in oggetto sostituisce completamente la Norma CEI EN 62366:2008-10, che rimane applicabile fino al 31-03-2018

Relations

Replaces: CEI EN 62366/A1
Replaces: CEI EN 62366

See also

IEC 62366-1:2015
EN 62366-1/EC:2015
EN 62366-1:2015

International Coding Standard (ICS)

11.040.01
Medical equipment in general
11.040
Medical equipment

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.

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.