scope:

This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in this part of ISO 14708 are type tests, and are to be carried out on samples of a device to show compliance. This part of ISO 14708 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.