NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-6 ; VDE 0750-1-6:2021-11 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 AMD 2 | 2020-08 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 2 More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| IEC 62366-1 AMD 1 | 2020-06 | Medical devices - Part 1: Application of usability engineering to medical devices; Amendment 1 More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| DIN EN ISO 14155 | 2021-05 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 More |
| DIN EN ISO 9241-1 | 2002-02 | Ergonomic requirements for office work with visual display terminals (VDTs) - Part 1: General introduction (ISO 9241-1:1997) (including Amendment AMD 1:2001); German version EN ISO 9241-1:1997 + A1:2001 More |
| DIN EN ISO 9241-11 | 2018-11 | Ergonomics of human-system interaction - Part 11: Usability: Definitions and concepts (ISO 9241-11:2018); German version EN ISO 9241-11:2018 More |
| DIN EN ISO 9241-110 | 2020-10 | Ergonomics of human-system interaction - Part 110: Interaction principles (ISO 9241-110:2020); German version EN ISO 9241-110:2020 More |
