BS-EN-62366 Medical devices. Application of usability engineering to medical devices

BS-EN-62366 - 2008/A1 EDITION - CURRENT
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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


Design, Medical equipment, Medical instruments, Equipment safety, Hazards, Medical technology, Instructions for use, Ergonomics

To find similar documents by classification:

11.040.01 (Medical equipment in general)

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Document Number

BS EN 62366:2008:2015

Revision Level




Publication Date

April 30, 2008


BS EN 62366:2008

Replaces Notes

Replaces BS EN 62366:2008 which remains current

Replaced By

BS EN 62366-1:2015 PD IEC/TR 62366-2:2016

Replaced by Notes

Replaced by BS EN 62366-1:2015 and PD IEC/TR 62366-2:2016 but remains current

Page Count




International Equivalent

EN 62366 Amd 1 (05/15) IEC AS IEC 62366:2007/AMD1:2014

Committee Number