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CEI EN 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 particolari per apparecchi medicali per la diagnosi in-vitro (IVD)
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Publication Date: 2017-08
Date Of Withdrawal (DOW): 2023-05
ValidFrom: 2017-09
ValidTo: 2025-09
Language: EN
Pages: 30
Issue Num.:  15613 E
Commitee: CEI-CT85/66
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La presente Norma si applica ad apparecchi per scopi medici di diagnosi in vitro (IVD), compresi gli apparecchi medicali di autodiagnosi IVD.
Rispetto alla precedente edizione, di cui costituisce revisione tecnica, sono state introdotte, fra le altre, le seguenti modifiche principali:
- esclusi dal campo di applicazione gli apparecchi automatici e semi-automatici da laboratorio per analisi ed altri usi della CEI EN 61010-2-081;
- aggiornati i simboli letterali ed i segni grafici relativi ai pericoli biologici ed alla codifica dei lotti (Tab. 1 art. 5);
- aggiornate le istruzioni per l'uso;
- aggiunte le prescrizioni per il costruttore di fornire istruzioni relativamente al trasporto, immagazzinamento e messa fuori servizio dell'apparecchiatura;
- aggiunti i riferimenti alla ISO 18113-5 per le istruzioni per l'uso di apparecchi medicali IVD di autodiagnosi;
- aggiunte le prescrizioni per sistemi ad interblocchi contenenti componenti elettrici/elettronici o programmabili.
La Norma in oggetto sostituisce completamente la Norma CEI EN 61010-2-101:2003-11, che rimane applicabile fino al 24-02-2020.
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 presente Norma é annullata e sostituita dalla Nuova edizione, CEI EN IEC 61010-2-101:2023-04 (CEI 66-19), tuttavia rimane applicabile fino al 26-09-2025.

Relations

Replaces: CEI EN 61010-2-101

See also

EN 61010-2-101:2017
IEC 61010-2-101:2015

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.

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

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