scope:

This document specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL 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. This document is also applicable to some non-implantable parts and ACCESSORIES of the devices (see NOTE 1). The electrical characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.