Implants for surgery – Active implantable medical devices
Part 2: Cardiac pacemakers
(ISO 14708-2:2019); German version EN ISO 14708-2:2022 Class/Status:
Standard,
valid
Released: 2022-12
VDE Art. No.: 0701201
This document specifies requirements that are applicable to those active impaltable devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance. This document was designed for Bradyarrhythmia pulse generators used with endocardial or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies
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