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Standard 2013-12

DIN EN 60601-1:2013-12;VDE 0750-1:2013-12

VDE 0750-1:2013-12

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012); German version EN 60601-1:2006 + Cor. :2010 + A1:2013

German title
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012); Deutsche Fassung EN 60601-1:2006 + Cor. :2010 + A1:2013
Publication date
2013-12
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Original language
German

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Publication date
2013-12
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Overview

The third edition of IEC 60601-1 was published in 2005. At the time of publication, there were 94 National Committee comments on the 2nd CDV and the FDIS that were deferred to a future amendment/revision. Each of their deferred comments was captured in a special format for further revision. By the time of the Auckland meeting (2008), the subcommittees had developed two Interpretation Sheets and an additional 15 issues from National Committees and other interested parties were received. At the Auckland meeting, IEC/TC 62 approved a project to develop the 1st amendment to IEC 60601-1:2005 based on the issues received at the time. The TC approved project scope refers to, but is not limited to: - the issues in the documents 62A/593/DC and 62A/602/INF; - the way in which risk management has been introduced into IEC 60601-1:2005; and - the way the concept of essential performance is used in IEC 60601-1:2005. Since the Auckland meeting, the secretariat has received 73 additional issues from National Committees or other interested parties for a total of 182 Issues Sheets. This amendment addresses those issues. Compared with DIN EN 60601-1 (VDE 0750-1):2007-07, Corrigendum 1 to DIN EN 60601-1 (VDE 0750-1 Corrigendum 1):2008-08 and Corrigendum 2 to DIN EN 60601-1 (VDE 0750-1 Corrigendum 1):2010-05, the following amendments have been made: a) errors in IEC 60601-1:2005 have been corrected; b) 496 different modifications have been considered. The responsible committee is UK 811.1 "Überarbeitung und Anpassung der allgemeinen Bestimmungen" ("Revision and adaptations of the general provisions") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.

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