nsBAS EN IEC 61010-2-101:2024

Sigurnosni zahtjevi za električnu opremu za mjerenje, upravljanje i laboratorijsku upotrebu - Dio 2-101: Sigurnosni zahtjevi za in vitro dijagnostičku (IVD) medicinsku opremu


Opšte informacije
Status:Projekt
Broj stranica:24
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:1.
Datum realizacije:24.04.2024
Predviđeni datum naredne faze:16.06.2024
Tehnički komitet:BAS/TC 51, Automatika
Direktive:
2017/746, Uredba (EU) o medicinskim sredstvim u in vitro dijagnostici
ICS:
11.040.55, Dijagnostička oprema
19.080, Električna i elektronička ispitivanja

Apstrakt
<span style="color:red">NEW!</span>IEC 61010-2-101:2018 is available as <a href="https://webstore.iec.ch/publication/63969">IEC 61010-2-101:2018 RLV</a> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.</br></br>IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).

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EN IEC 61010-2-101:2022, identičan
IEC 61010-2-101:2018, identičan

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