NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 14708-3 ; VDE 0750-20-3:2022-12 [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 60601-1-2 | 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 61000-4-3 | 2006-02 | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test More |
| IEC 61000-4-3 AMD 1 | 2007-11 | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test; Amendment 1 More |
| IEC 61000-4-3 AMD 2 | 2010-03 | Electromagnetic compatibility (EMC) - Part 43: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test; Amendment 2 More |
| ISO 14708-1 | 2014-08 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer More |
| ISO/TS 10974 | 2018-04 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
