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

 
Visit the page here

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