Human Factors Engineering for Medical Devices – IEC 62366 and IEC 60601-1-6
The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively.
- There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design including ‘usability,’ ‘human factors engineering’ (HFE)” and ‘ergonomics.’
- HFE has been added to regulatory requirements to:
- reduce medical device use error
- create more operator friendly and intuitive devices
- reduce the training costs for both manufacturers and end-users.
Visit our main page for clear and educational resources and guidance, including:
- Standards for Human Factors Engineering
- FDA Requirements
- Articles & Published book resources
- Podcasts and recorded webinars
Contact the European team to learn more