1 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 leads or epicardialleads. 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.
Any features of an active implantable medical device intended to treat tachyarrhythmias
are covered by ISO 14708‑6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.