NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 60601-2-46 ; VDE 0750-2-46:2025-04 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 |
| EN 50637 | 2017-11 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children More |
| IEC 60601-1-10 | 2007-11 | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers More |
| IEC 60601-1-10 AMD 1 | 2013-11 | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers More |
| IEC 60601-1-10 AMD 2 | 2020-07 | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers; 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 |
| IEC 60601-1-12 | 2014-06 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment More |
| IEC 60601-1-12 AMD 1 | 2020-07 | Medical Electrical Equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment; Amendment 1 More |
| IEC 60601-1-8 | 2006-10 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems More |
