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

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

IEC 62366 was initially published in 2007. In February 2015, IEC 62366-1:2015 was published – Medical devices - Part 1: Application of usability engineering to medical devices – focused on usability as it relates to safety.[4] In May 2016, IEC/TR 62366-2 was published – Medical devices - Part 2: Guidance on the application of usability engineering to medical devices – focused on goals other than safety.[5]


See also

References

  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.
  4. ^ International Electrotechnical Commission (2015). "IEC 62366-1:2015 - Part 1: Application of usability engineering to medical devices". International Electrotechnical Commission. Retrieved 14 May 2019.
  5. ^ International Electrotechnical Commission (2016). "IEC/TR 62366-2 - Part 2: Guidance on the application of usability engineering to medical devices". International Electrotechnical Commission. Retrieved 14 May 2019.

External links