DANSK DSF/FPREN ISO 14708-6 PDF

This document specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CRT-DS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This document was designed for tachyarrhythmia PULSE generators used with either endocardial or epicardial LEADs. At the time of this edition, the authors recognized the emergence of technologies that do not use ENDOCARDIAL or EPICARDIAL LEADS for which adaptations of this part will be required. Such adaptations are left to the discretion of MANUFACTURERS incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.