This standard specifies requirements applicable to implantable cardioverter defibrillators and CRT-Ds, and functional requirements for active implantable medical devices to treat tachyarrhythmia.
The tests specified in ISO 14708 are type tests and must be performed on samples of a device to demonstrate conformity.
This standard is designed for tachyarrhythmia pulse generators for use with endocardial or epicardial leads. At the time of this publication, the authors acknowledged that technologies that do not use endocardial or epicardial leads have emerged and adaptations to this section will be necessary. Such adaptations are left to the discretion of manufacturers using these technologies.
The characteristics of the implantable pulse generator or lead should be determined either by the appropriate method detailed in this document or by another method that has been shown to have equal or better accuracy than the specified method.
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