Document Center is acquired by Nimonik

What is BS EN 62366:2008?

BS EN 62366 looks at the application of usability engineering to medical devices. Health practices today are heavily dependent on the use of medical equipment, medical instruments and medical technology for both the observation and treatment of patients. Many of these medical devices are developed without applying a usability engineering process or instructions for use, so they’re non intuitive and difficult to master. The usability engineering process is specifically developed to reduce everyday errors, lessen risks and ensure general equipment safety.

How does it work?

BS EN 62366 not only describes the usability engineering process, but also gives guidance on how to implement and execute this method to ensure safety in medical devices – from design, right though to usage. It’s specifically intended for manufacturers and other technical committees who are responsible for the development of the standards for medical equipment. Set out clearly, this standard makes it easy for manufacturers to follow, analyse, specify, design, verify and validate the usability engineering process.

Who should buy it?

    Manufacturers responsible for medical equipment
    Ergonomic designers
    Organizations providing medical devices
    Health care professionals and specialists
    Medical equipment engineers
    Medical equipment suppliers