NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 80601-2-13 ; VDE 0750-2-13:2022-10 [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 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; Amendment 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 intended for use in the emergency medical services environment; Amendment 1 More |
| IEC 62570 | 2014-02 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment More |
| ISO 10524-1 | 2018-01 | Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices More |
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
