ISO 14708-5 Implants for Surgery - Active Implantable Medical Devices - Test Standard for Circulatory Support Devices

Material Testing

ISO 14708-5 Implants for Surgery - Active Implantable Medical Devices - Test Standard for Circulatory Support Devices

This standard specifies requirements for the safety and performance of implantable active circulation assist devices, including type testing, animal studies, and clinical evaluation requirements.

ISO 14708-5 Implants for Surgery - Active Implantable Medical Devices - Test Standard for Circulatory Support Devices

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 a combination of devices and one or more accessories. It is not necessary for all of these parts to be partially or fully implantable, but there is a need to identify key requirements for non-implantable parts and accessories if they may affect the safety or performance of the implantable device.

The tests specified in this standard are type tests and will be performed on a device sample to evaluate the behavioral responses of the device and are not intended to be used in routine testing of manufactured products.

The scope of this standard includes:

  • Ventricular assist devices (VAD), left or right heart support;
  • Total artificial hearts (TAH);
  • Biventricular assist devices (biVAD);
  • Percutaneous assistive devices;
  • Pediatric assist devices.

EUROLAB assists manufacturers with ISO 14708-5 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.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

Whatsapp