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DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 80601-2-78 ; VDE 0750-2-78:2025-05 [New] 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 60601-1-10 | 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 60601-1-11 | 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 60601-1-2 | 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests More |
| IEC 60601-1-6 | 2010-01 | Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability 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 |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 22523 | 2006-10 | External limb prostheses and external orthoses - Requirements and test methods More |
| DIN EN IEC 61924-2 ; VDE 0878-924-2:2022-08 | 2022-08 | Maritime navigation and radiocommunication equipment and systems - Integrated navigation systems (INS) - Part 2: Modular structure for INS - Operational and performance requirements, methods of testing and required test results (IEC 61924-2:2021); German version EN IEC 61924-2:2021 More |
