Standards in Focus: DIN EN 62366 Usability According to Annex C

The current version of DIN EN 62366 is split into 2 parts.
The normative part is published under the standard number DIN EN 62366-1 (VDE 0750-241), and the Technical Report is published as IEC 62366-2. In the Technical Report, supplementary instructions are given for carrying out the usability engineering process. This modification is intended to take account of the fact that usability is becoming increasingly important in the prevention of user and application errors.

Usability According to Annex C

Particular attention should be paid to Annex C. This Annex addresses the interest of many manufacturers who use user interfaces or parts thereof that were already on the market before the current version of this standard was published. Such components were not developed using the EN 62366 processes and are therefore of unknown provenance with regard to these processes. The idea behind an abbreviated verification procedure is obvious; user interfaces that have been functioning without problems in the market for a long time should not necessarily be subjected to an elaborate verification path. In other words, an unchanged user interface that was developed before the publication of DIN EN 62366-1 is evaluated using this annex to determine compliance with this standard.

In doing so, the manufacturer must then

  1. describe the application specifications,
  2. perform a review of information from the post-marketing phase,
  3. discuss usability-related hazards and hazard situations,
  4. verify and document risk control, and
  5. perform the residual risk assessment.

If the risk assessment does not result in an unacceptable risk, this way should suffice as proof of compliance with EN 62366-1. However, it should be noted that any changes to the user interface exclude this path. After changes, only the unchanged parts remain under this simplified process, while the changed parts are subject to the complete process of this family of standards.

Please don’t hesitate to contact our experts regarding the verification documentation according to MDR.


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