NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 80601-2-13 ; VDE 0750-2-13:2022-10 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN 60601-1-9 ; VDE 0750-1-9:2021-05 | 2021-05 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007 + A1:2013 + A2:2020); German version EN 60601-1-9:2008 + A1:2013 + A2:2020 More |
| DIN EN 62304 ; VDE 0750-101:2016-10 | 2016-10 | Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015 More |
| DIN EN 62366-1 ; VDE 0750-241-1:2021-08 | 2021-08 | Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 More |
| DIN EN 62570 | 2016-09 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2014); German version EN 62570:2015 More |
| EGV 1272/2008 | 2008-12-16 | Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| IEC 80601-2-49 | 2018-03 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors More |
| IEC/TR 60083 | 2015-10 | Plugs and socket-outlets for domestic and similar general use standardized in member countries of IEC More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 19223 | 2019-07 | Lung ventilators and related equipment - Vocabulary and semantics More |
