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CEI EN 60601-2-25

CEI Classification: 62-76

Apparecchi elettromedicali
Parte 2: Prescrizioni particolari relative alla sicurezza fondamentale e alle prestazioni essenziali degli elettrocardiografi
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Publication Date: 2016-04
ValidFrom: 2016-05
Language: EN
Pages: 104
Issue Num.:  14831 E
Commitee: CEI-CT62, CEI-SC62D
shopping_cart Starting from € 68.00
La Norma stabilisce i requisiti di sicurezza di base e le prestazioni essenziali degli elettrocardiografi destinati da soli, o come parte di un sistema elettromedicale, alla produzione di elettrocardiogrammi per scopi diagnostici. Le apparecchiature destinate ad impieghi in condizioni ambientali estreme o non controllate al di fuori dell'ambiente ospedaliero o dello studio del medico, come ad esempio nelle ambulanze e durante il trasporto aereo, devono rispettare questa Norma. Ulteriori norme si possono applicare alle apparecchiature elettromedicali a seconda degli ambienti di utilizzo. Non sono incluse nel campo di applicazione di questa Norma:
a) la parte dell'apparecchiatura elettromedicale che fornisce la funzioni di vettorcardiografia;
b) le apparecchiature elettromedicali ambulatoriali elettrocardiografiche cui si applica la EN 60601-2-47 non destinate ad ottenere elettrocardiogrammi a scopo diagnostico;
c) i monitor cardiaci cui si applica la EN 60601-2-27 non destinati ad ottenere elettrocardiogrammi per scopi diagnostici.
La Norma in oggetto sostituisce completamente le Norme CEI EN 60601-2-25:1996-12 e
CEI EN 60601-2-51:2000-06 che rimangono applicabili fino al 15-09-2018.

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.

Relations

Replaces: CEI EN 60601-2-25
Replaces: CEI EN 60601-2-25/A1

See also

EN 60601-2-25:2015
IEC 60601-2-25:2011

International Coding Standard (ICS)

11.040.99
Other medical equipment
11.040.55
Diagnostic equipment
* Including medical monitoring equipment, medical thermometers and related materials
11.040.50
Radiographic equipment
* Including radiographic diagnostic and therapy equipment
* Dental, medical and industrial radiographic films, see 37.040.25

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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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.