NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 14708-6 ; VDE 0750-20-6:2022-12 [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 14708-2 | 2019-09 | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers 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 14708-2 ; VDE 0750-20-2:2022-12 | 2022-12 | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019); German version EN ISO 14708-2:2022 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 ISO 8601-1 | 2020-12 | Date and time - Representations for information interchange - Part 1: Basic rules (ISO 8601-1:2019) More |
| ISO 27185 | 2012-02 | Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements More |
| ISO 8601-1 | 2019-02 | Date and time - Representations for information interchange - Part 1: Basic rules More |
