This document is the report of compliance with the usability requirements of EN 60601-1-6.
The validation must be completed with the documents
– Module Usability Engineering File
– Usability Summative Evaluation present in the template Usability Validation Module EN 62366-1.
Available Languages: English
The information contained on this page and in the documents referred to is valid and current as of 07/17/23. Legislative and regulatory provisions are subjec to change and updating by the Regulatory Authorities. This being said, the writer declines all responsibility for any possible lack of topicality and/or accuracy of the information that may have occurred at the same time as or following the publication of this page and the documents referred to. Disclaimer
