IEC 61010-2-101-ed.3.0

Detail information

Designation: IEC 61010-2-101-ed.3.0

Publication date: 05/10/2018

Pages: 34

Country: International technical standard

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Anotation

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). L’IEC 61010-2-101:2018 s’applique aux appareils destines aux applications medicales de diagnostic in vitro (DIV), y compris aux appareils medicaux dautotest DIV. Elle a le statut dune publication groupee de securite conformement au Guide IEC 104. Ce document a ete elabore en etroite collaboration avec le groupe de travail CENELEC BTTF 88.1. Cette troisieme edition annule et remplace la deuxieme edition parue en 2015. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: - adaptation des modifications introduites par l’Amendement 1 de l’IEC 61010-1; - ajout a l’Article 6 de la tolerance pour la stabilite du materiel d’essai en tension alternative. Cette Partie 2-101 est destinee a etre utilisee conjointement avec l’IEC 61010-1. Elle a ete etablie sur la base de la troisieme edition (2010) et de son Amendement 1 (2016).