Cover 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
Class/Status: Standard, withdrawn
Released: 2016-04
VDE Art. No.: 0700947

Contents (only German)

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.

Standard:

DIN EN 60601-1-10 VDE 0750-1-10:2021-11

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

102.65 € 
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