NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 14708-2 ; VDE 0750-20-2:2022-12 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN 60601-1-2 ; VDE 0750-1-2:2022-01 | 2022-01 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + A1:2020); German version EN 60601-1-2:2015 + A1:2021 More |
| DIN EN 60601-2-27 ; VDE 0750-2-27:2015-04 | 2015-04 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011 + Cor.:2012); German version EN 60601-2-27:2014 More |
| DIN EN 61000-4-2 ; VDE 0847-4-2:2009-12 | 2009-12 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test (IEC 61000-4-2:2008); German version EN 61000-4-2:2009 More |
| DIN ISO 8601-1 | 2020-12 | Date and time - Representations for information interchange - Part 1: Basic rules (ISO 8601-1:2019) More |
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 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 60601-2-27 | 2011-03 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment More |
| IEC 61000-4-2 | 2008-12 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test More |
| ISO 14155 | 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice More |
| ISO 14708-6 | 2019-09 | Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) More |
