Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Usability is an integral part of IEC 60601-1: 2005 Third Edition. Specifically, the mention of usability appears in clauses throughout the standard. For example:
To comply with the requirements of Clauses 7.1.1 and 12.2, the manufacturer needs to provide their usability engineering process as part of the documents in the evaluation package.
This usability engineering process could be included as part of the risk management file, since risk from usability issues need to be processed as part of risk management.
The easiest way to comply with the requirements for usability is to apply these in IEC 60601-1-6: 2010 – "Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability" when creating the Usability Engineering Process, but IEC 60601-1-6: 2010 is not required for Product Certification.