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 |
|---|---|---|
| ISO 11318 | 2002-08 | Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensional and test requirements More |
| ISO 14117 | 2019-09 | Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices 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 5841-3 | 2013-04 | Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers More |
| DIN EN ISO 14155 | 2021-05 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 More |
| DIN EN ISO 14708-6 ; VDE 0750-20-6:2022-12 | 2022-12 | Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019); German version EN ISO 14708-6:2022 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 |
| DIN EN ISO 15223-1 | 2022-02 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021); German version EN ISO 15223-1:2021, with CD-ROM More |
| DIN EN 60068-2-14 ; VDE 0468-2-14:2010-04 | 2010-04 | Environmental testing - Part 2-14: Tests - Test N: Change of temperature (IEC 60068-2-14:2009); German version EN 60068-2-14:2009 More |
| DIN EN 60601-1 ; VDE 0750-1:2022-11 | 2022-11 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor1:2006 + Cor2:2007 + A1:2012 + A1:2012/Cor1:2014 + A2:2020); German version EN 60601-1:2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021 More |
