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

BS-EN-62366 - 2008 EDITION - CURRENT
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Included in this current edition are the following subparts:

 2008 EDITION - April 30, 2008
 2008/A1 EDITION - June 1, 2015

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


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

To find similar documents by classification:

11.040.01 (Medical equipment in general)

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Document Number

BS EN 62366:2008

Revision Level




Publication Date

April 30, 2008

Replaced By

BS EN 62366:2008+A1:2015

Replaced by Notes

Replaced by BS EN 62366:2008+A1:2015 but remains current

Page Count




International Equivalent

IEC 62366:2007 EN 62366:2008

Committee Number