IEC 62366

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The international standard IEC 62366 medical devices - Application of usability engineering to medical devices[1] is a standard which specifies usability requirements for the development of medical devices. It is harmonized by the European Union (EU)[2] and the United States (US),[3] and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

Summary of IEC 62366[edit]

The IEC 62366 standard calls out the errors caused by inadequate medical device usability have become an increasing cause for concern. IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not apply to clinical decision-making that may be related to the use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability. Manufacturers of medical electrical equipment who comply with IEC 60601-1-6 need to also comply by extension to IEC 62366 as part of IEC 60601-1 Edition 3.1

History of IEC 62366[edit]

IEC 62366 was published for the first time in 2007. In February 2015 IEC 62366-1:2015 was published, Medical devices - Part 1: Application of usability engineering to medical devices. In May 2016 IEC/TR 62366-2 was published, Medical devices - Part 2: Guidance on the application of usability engineering to medical devices.

See also[edit]


  1. ^ International Electrotechnical Commission (2014). "Application of usability engineering to medical devices" (PDF). INTERNATIONAL IEC STANDARD 62366 edition 1.1 2014-01. International Electrotechnical Commission. Retrieved 26 January 2015.
  2. ^ Staff (27 November 2008). "European standards Medical devices". European Commission. European Commission's Directorate General for Enterprise and Industry. Retrieved 26 January 2015.
  3. ^ Staff (7 September 2014). "Recognized Consensus Standards". FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 26 January 2015.

External links[edit]