EN 45502-2-1 Standard Test for Active Implantable Medical Devices, Active Implantable Medical Devices to Treat Bradyarrhythmia (Pacemakers)

EUROLAB laboratory provides testing and compliance services within the scope of EN 45502-2-1 standard. This section 2-1 specifies requirements that apply to active implantable medical devices to treat bradyarrhythmias.

The tests specified in EN 45502 are type tests and must be performed on samples of a device to demonstrate conformity.

This section 2-1 is also applicable to some non-implantable parts and accessories of devices. The properties of the applicable pulse generator or lead shall be determined either by the appropriate method detailed in this section 2-1 or by any other method which has been shown to have an accuracy equal to or better than the specified method.

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 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 45502-2-1 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.