IEC 62366-1:2015 was published on February 25, 2015. The experts involved in the subject expect harmonization to be effected in mid-2016. Given this, it is high time to address the changes.
At present, two editions of the IEC 62366 standard exist in parallel: the IEC 62366-1:2015 edition, and the IEC 62366:2007 edition including the amendment of 2014. The amendment had published one major aspect of the IEC 62366-1:2015 standard in advance, namely the handling of user interfaces of unknown provenance (UOUP) and/or devices that were developed without following a usability process. The usability of these “legacy products” can be demonstrated with the help of market data.
Beyond the above, the IEC 62366-1:2015 standard introduces other major changes
The terms “usability-validation” and “-verification” have been replaced by the term “evaluation”.
The standard differentiates between “formative evaluation”, which takes place in parallel to design and development, and “summative evaluation” at the end of the process. Given this, manufacturers now already have to address evaluation of the user interface during the design and development process and can no longer wait until the end of design and development.
The term “primary operating function” has been dropped from the standard. Instead, the new standard only addresses the “hazard-related use scenarios” of medical devices. The validation of frequently used uncritical functions is no longer mandatory.
“Use scenarios” have gained in importance and have to be specified in greater detail now.
Medical device manufacturers can immediately start aligning their processes to the new requirements. However, when doing so they should take into account that introduction of an IEC 62366-2 standard is also planned for 2016. Although this standard will not introduce any additional normative requirements, it will contain tutorial information and assist with meeting the requirements of Part 1 of the standard.