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 |
|---|---|---|
| IEC 61000-4-2 | 2008-12 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test More |
| ISO 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
| ISO 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes 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 |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 15223-1 | 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements 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 |
| ISO/TR 14283 | 2018-01 | Implants for surgery - Essential principles of safety and performance More |
