ISO 14708-2 Implants for Surgery - Active Implantable Medical Devices - Test Standard for Pacemakers

ISO 14708-2 specifies requirements applicable to active implantable medical devices for treating bradyarrhythmias and devices providing treatments for cardiac resynchronization. The tests specified in this standard are type tests and must be performed on a device sample to demonstrate conformity.

This standard is designed for bradyarrhythmia pulse generators for use with endocardial or epicardial leads. During this edition, the authors acknowledged the emergence of lead-free technologies for which adaptations of this chapter would be required. Such adaptations are left to the discretion of manufacturers using these technologies.

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 shown to have an accuracy equal to or better than the specified method. In case of dispute, the method detailed in this standard applies.

The device, commonly referred to as an active implantable medical device, may actually be a single device, a combination of devices, or a device or combination of devices and one or more accessories. It is not necessary for all of these parts to be partially or fully implantable, but certain requirements for non-implantable parts and accessories should be specified if this could affect the safety or performance of the implantable device.

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