NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 62366-1 ; VDE 0750-241-1:2021-08 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| DIN EN ISO 7010 | 2020-07 | Graphical symbols - Safety colours and safety signs - Registered safety signs (ISO 7010:2019); German version EN ISO 7010:2020 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 ISO 9001 | 2015-11 | Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 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 |
| 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 60601-1-11 | 2015-01 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment More |
| IEC 60601-1-11 AMD 1 | 2020-07 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment; Amendmenz-1 More |
