NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 62304 ; VDE 0750-101:2016-10 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 12100 | 2011-03 | Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010); German version EN ISO 12100:2010 More |
| DIN EN 61508-5 ; VDE 0803-5:2011-02 | 2011-02 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (IEC 61508-5:2010); German version EN 61508-5:2010 More |
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More |
| IEC 60601-1 AMD 1 | 2012-07 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 1 More |
| IEC 60601-1-6 | 2010-01 | Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability More |
| IEC 61010-1 | 2010-06 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements More |
| IEC 61508-3 | 2010-04 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
