IEC 62366 – Requirements regarding the usability of medical devices

Usability and ergonomics are important quality- and performance features of medical devices. Both standards EN 62366 and EN 60601-1-6 have been harmonized under the Medical Device Directive (93/42/EEC and 98/79/EEC) and describe how usability aspects should be incorporated into the design process of medical devices.

Make use of our expertise in early design stages like the concept phase and feasibility analysis. Ergonomics- and usability engineering start in these stages rather than on a finished device. The integration of user- and customer requirements into design are the key to success.

The PROSYSTEM AG is member of the workgroup IEC 62A/ISO 210 JWG4 and is actively involved in the standards IEC 62366-1 and IEC 62366-2. Make use of our network for your future development projects.