BS-EN-62366 › Medical devices. Application of usability engineering to medical devices
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PARTIALLY REPLACED BY - June 30, 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
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
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BS EN 62366:2008:2015
April 30, 2008
Replaces BS EN 62366:2008 which remains current
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
EN 62366 Amd 1 (05/15) IEC AS IEC 62366:2007/AMD1:2014