BS EN 62366:2008 Application of usability engineering to medical devices

BS EN 62366:2008 is the international standard that describes a usability engineering process, and provides guidance on how to implement and execute the process to provide safety in medical devices. It is intended to be useful for manufacturers and also for technical committees responsible for the preparation of standards for medical devices.

BS EN 62366 specifies a process for a manufacturer to follow, to analyse, specify,
design, verify and validate usability, related to the safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correctuse and use errors, i.e. normal use

It can be used to identify but does not assess or mitigate the risks associated with abnormal use. For the purposes of BS EN 62366,  USABILITY is limited to characteristics of the user interface.

If the usability engineering process detailed in this standard has been complied with, and the acceptance criteria documented in the usability validation plan have been met, then the residual risks (as defined in BS EN ISO 14971) associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary.

BS EN 62366 does not apply to clinical decision-making relating to the use of a medical device.

Contents of BS EN 62366 include:

• Scope
• Normative references
• Terms and definitions
• Principles
• General requirements
• Usability engineering process
• Residual risk
• Information for safety
• Usability engineering file
• Scaling of the usability engineeering  effort
• Application specification
• Frequently used functions
• Identification of hazards and hazardious situations related to usability
• Identification of characteristics related to safety
• Identification of known or foreseeable hazards and hazardous situations
• Primary operating functions
• Usability specification
• Usability validation plan
• User interface design and implementation
• Usability verification
• Usability validation
• Accompanying document
• Training and materials for training
• General guidance and rationale
• Categories of user action
• Examples of use errors, abnormal use and possible causes
• Guidance on the usability engineering process
• Questions that can be used to safety
• Examples of possible usability-related hazardous situations
• Usability goals: Illustrative example for a home parenteral infusion pump
• Recommended reading list
• Reference to the essential principles
• Normative references to international publications with their corresponding European publications
• Coverage of Essential Requirements of EC Directives