NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 82304-1 ; VDE 0750-102-1:2018-04 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 62304 | 2006-05 | Medical device software - Software life cycle processes More |
| DIN EN ISO 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More |
| DIN EN 60601-1 Beiblatt 2 ; VDE 0750-1 Beiblatt 2:2009-09 | 2009-09 | Graphical symbols for electrical equipment in medical practice (IEC/TR 60878:2003, modified), Text in German and English More |
| DIN EN 60601-2-10 ; VDE 0750-2-10:2017-09 | 2017-09 | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012 + A1:2016); German version EN 60601-2-10:2015 + A1:2016 More |
| DIN EN 60601-2-11 ; VDE 0750-2-11:2016-04 | 2016-04 | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment (IEC 60601-2-11:2013); German version EN 60601-2-11:2015 More |
| DIN EN 60601-2-17 ; VDE 0750-2-17:2016-03 | 2016-03 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2013); German version EN 60601-2-17:2015 More |
| DIN EN 60601-2-18 ; VDE 0750-2-18:2016-10 | 2016-10 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (IEC 60601-2-18:2009); German version EN 60601-2-18:2015 More |
| DIN EN 60601-2-2 Beiblatt 1 ; VDE 0750-2-2 Beiblatt 1:2014-02 | 2014-02 | Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories; Supplement 1: High frequency surgical equipment - Operation and maintenance (IEC/TR 61289:2011) More |
| DIN EN 60601-2-22 Beiblatt 1 ; VDE 0750-2-22 Beiblatt 1:2007-10 | 2007-10 | Safety of laser products - Guidelines for the safe use of laser beams on humans (IEC/TR 60825-8:2006) More |
| DIN EN 60601-2-23 ; VDE 0750-2-23:2016-08 | 2016-08 | Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:2011); German version EN 60601-2-23:2015 More |
