Testing of Rehabilitation Devices (IEC 80601-2-78)

Rehabilitation technology has advanced significantly over the past decade. Among the latest innovations is a new class of large-scale, multifunctional rehabilitation systems designed to support intensive therapy for patients recovering from neurological injuries, musculoskeletal disorders, and long-term mobility impairments. These devices integrate complex mechanical systems, advanced electronics, and intuitive user interfaces to create a highly adaptable therapeutic environment.

Early and well-structured rehabilitation is particularly critical following a stroke, as it plays a key role in restoring movement, balance, and functional independence. To support this process, we have recently tested a technologically advanced rehabilitation device specifically developed for post-stroke therapy. This system belongs to a category of complex, stationary rehabilitation platforms that combine sophisticated mechanics, electronics, and a user-friendly touchscreen interface.

We are proud to have evaluated such a device in our laboratory. Due to its complexity, safety testing requires significant time and effort. Special attention must be given to multiple potential trapping zones created by moving parts, ensuring the safety of both patients and operators. Additionally, protection against electrical shock presents a challenge, as these systems incorporate numerous motors and other mains-powered components.

For this type of equipment, the IEC 80601-2-78 standard must be applied in conjunction with the general medical electrical equipment standard to ensure full compliance.

SIQ is accredited to perform testing in accordance with IEC 80601-2-78 and can issue accredited test reports. Furthermore, as this standard is in our IECEE CB Scheme scope, we are able to issue internationally recognized CB certificates for such devices.

More information:
Janez Vidmar
E-mail: janez.vidmar@siq.si
Tel.: +386 1 4778 256