EN 45502-2-2 Test for Active Implantable Medical Devices

EUROLAB laboratory provides testing and compliance services within the scope of EN 45502-2-2 standard. This standard specifies requirements applicable to the functionality of implantable cardioverter defibrillators and active implantable medical devices to treat tachyarrhythmia.

The tests specified in EN 45502 are type tests and must be performed on samples of a device to demonstrate conformity. This part of EN 45502 is also applicable to some non-implantable parts and accessories of devices.

The characteristics of the applicable pulse generator or lead shall be 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 the event of disagreement, the method detailed in this Special Standard shall apply.

Any aspect of an active implantation medical device intended to treat bradyarrhythmias is covered by EN 45502-2-1. Special requirements for active implantable medical devices (Pacemakers) to treat bradyarrhythmias.

The device commonly referred to as an active implantation 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 some requirements for non-implantable parts and accessories need to be specified if they may affect the safety or performance of the implantable device.

EUROLAB assists manufacturers with EN 45502-2-2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.