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DIN EN 60601-1-10 VDE 0750-1-10:2016-04

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DIN EN 60601-1-10 VDE 0750-1-10:2016-04

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + A1:2013); German version EN 60601-1-10:2008 + A1:2015

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The first edition of IEC 60601-1-10 was published in 2007. This amendment is intended to update the references to IEC 60601-1:2005 to include Amendment 1:2012, IEC 60601-1-6:2006 to IEC 60601-1-6:2010 including its Amendment 1 and IEC 60601-1-8:2006 to include its Amendment 1:2012. This amendment also removes the normative reference to IEC 62304:2006. This collateral standard made referenced to IEC 62304 because elements of the software process were not fully covered by Clause 14 of IEC 66001-1:2005. Amendment 1 to IEC 60601-1:2005 incorporates the needed software process requirement into Clause 14. Therefore, in is redundant and potentially confusing to have the explicitly called out in this collateral standard.

Author VDE
Editor VDE
Document type Standard
Format Paper
ICS 11.040.01 : Medical equipment in general
Number of pages 46
Replace DIN EN 60601-1-10 (2008-11)
Cross references EN 60601-1-10 (2008-04), IDT
Weight(kg.) 0.1782
Year 2016
Document history DIN EN 60601-1-10 (2016-04)
Country Germany
Keyword DIN EN 60601;DIN EN 60601-1;EN 60601;EN 60601-1;EN 60601-1-10;60601