View larger
DIN EN 60601-1-10 VDE 0750-1-10:2016-04
New product
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 + A1:2015More info
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 |