Countdown: IEC 60601-1 Third Edition
03 October 2011
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:
- Clause 7.1.1 addresses the usability requirements for Medical Equipment's identification, marking, and accompanying documentations.
- Clause 12.2 addresses the usability requirements for Medical Equipment's controls and instrumentations, along with the accuracy of the controls and instrumentations.
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.