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CEI EN IEC 61010-2-101

CEI Classification: 66-19

Prescrizioni di sicurezza per apparecchi elettrici di misura, controllo e per utilizzo in laboratorio
Parte 2-101: Prescrizioni di sicurezza per apparecchi medicali per la diagnosi in-vitro (IVD)
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Publication Date: 2023-04
ValidFrom: 2023-05
Language: EN
Pages: 42
Issue Num.:  19355 E
Commitee: CEI-CT85/66
La presente Norma si applica agli apparecchi destinati a scopi medici di diagnostica in vitro (IVD), incluse le autodiagnosi dei dispositivi IVD, ed ha lo status di pubblicazione di sicurezza di gruppo, come definito nella Guida IEC 104. La presente edizione costituisce una revisione tecnica ed include le seguenti modifiche tecniche significative rispetto alla precedente edizione:
- adattamento delle modifiche introdotte dall'Emendamento 1 della IEC 61010-1;
- aggiunta della tolleranza per la stabilità delle apparecchiature di prova della tensione in c.a., nell’Articolo 6.
Questa Parte 2-101 è destinata ad un uso congiunto con la Norma CEI EN 61010-1:2013-10.
La Norma in oggetto sostituisce completamente la Norma CEI EN 61010-2-101:2017-08, che rimane applicabile fino al 26-09-2025.
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 61010-2-101

See also

EN IEC 61010-2-101:2022
IEC 61010-2-101:2018
EN IEC 61010-2-101/A11:2022

International Coding Standard (ICS)

11.040.55
Diagnostic equipment
* Including medical monitoring equipment, medical thermometers and related materials
19.080
Electrical and electronic testing
* Including testing equipment
* Equipment for measuring electrical and magnetic quantities, see 17.220.20

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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.

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  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

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