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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 |