Implants for surgery – Active implantable medical devices
Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators);
(ISO/DIS 14708-6:2018); German and English version prEN ISO 14708-6:2018 Class/Status:
Released: 2018-09 Published: 2018-08-03
VDE Art. No.: 1701379
End of objection deadline: 2018-10-03
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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