The IEC 62366-1 standard was first published in 2007 and defines the requirements for applying usability engineering to medical devices. The main objective of the standard is to reduce the risks associated with user interaction with the device, ensuring safe and effective use. Usability is particularly important in medical devices, as misuse or user errors can lead to serious incidents or negative outcomes for patients.
In the 2015 version of IEC 62366-1, Annex C was introduced to provide practical guidance and a systematic approach for evaluating existing user interfaces, particularly those that were not developed following formal usability engineering processes. The current and latest version of the standard is the 2015 edition, which redefines and improves many of the usability approaches compared to the initial version.
Annex C was created to address the issue of User Interfaces of Unknown Provenance (UOUP), which are user interfaces with no detailed documentation on their development process or that were not created following modern usability engineering practices. These devices, which are often in use for many years, may pose unknown risks to users and patients.
Annex C allows manufacturers to retrospectively create a usability file, starting with the creation of a Use Specification, using existing documentation, post-market data, complaints, and field reports. The aim is to provide an alternative process that manufacturers can use to identify usability-related risks and propose modifications or improvements to align the devices with modern standards.
In summary, Annex C is a valuable tool for ensuring the safety of legacy user interfaces, enabling manufacturers to adapt existing devices without the need for complete redesigns.