BSI releases full revision of British Standard for usability engineering for medical devices

28 August 2020

BSI, in its role as the UK National Standards Body, has published BS EN 62366-1:2015+A1:2019, Medical devices - Part 1: Application of usability engineering to medical devices. The newly revised British Standard aims to help manufacturers improve usability of medical devices by setting out an appropriate usability engineering process. 

The amended standard replaces BS EN 62366-1:2015 and it now specifies a process with which manufacturers can analyse, specify, develop and evaluate the usability of a medical device as it relates to safety in normal use. The process is intended to identify and minimize use errors and thereby reduce use-associated risks.

Rob Turpin, Head of Healthcare Standards at BSI said: “As the technology that powers medical devices advances, so does the demand for it to be intuitive and easy to use. The newly revised British Standard describes a process for eliminating user errors, and therefore the risks associated with the usability of medical devices.”

It is applicable for manufacturers of medical equipment and systems.

It has been prepared by experts in the field of Electrical Equipment used in medical practice.

The standard is available for download here: https://shop.bsigroup.com/ProductDetail/?pid=000000000030359003.

- ENDS -

Notes to the editor:

*Committee

  • Association of Renal Technologists
  • AXREM - Association of Healthcare Technology Providers for Imaging, Radiotherapy and Care
  • Barema, the Association for Anaesthetic and Respiratory Device Suppliers
  • EMC Test Laboratories Association
  • GAMBICA Association Limited
  • Human Factors Centre Ltd
  • IPEM - Institute of Physics and Engineering in Medicine
  • MHRA - Medicines and Healthcare products Regulatory Agency
  • Medical Research Council
  • PSMA - Power Supply Manufacturers Association
  • techUK