IEC 62366

IEC 62366 medical devices - Application of usability engineering to medical devices[1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies usability requirements for the development of medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements.

## Contents

* 1 Summary of IEC 62366
* 2 History of IEC 62366
* 3 See also
* 4 References
* 5 External links

## Summary of IEC 62366

The IEC 62366 standard aims to reduce errors caused by inadequate medical device usability. Such errors 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 address clinical decision-making related to 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.[2] 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.[3]

## See also

* International Electrotechnical Commission (IEC)
* List of IEC standards
* IEC 60601

## 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. http://webstore.iec.ch/preview/info_iec62366{ed1.1}b.pdf.
2. ↑ International Electrotechnical Commission (2015). "IEC 62366-1:2015 - Part 1: Application of usability engineering to medical devices". International Electrotechnical Commission. https://webstore.iec.ch/publication/21863.
3. ↑ International Electrotechnical Commission (2016). "IEC/TR 62366-2 - Part 2: Guidance on the application of usability engineering to medical devices". International Electrotechnical Commission. https://webstore.iec.ch/publication/24664.

## External links

* "IEC 62366" at International Electrotechnical Commission

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List of International Electrotechnical Commission standards

IEC standards|

* IEC 60027
* IEC 60034
* IEC 60038
* IEC 60062
* IEC 60063
* IEC 60068
* IEC 60112
* IEC 60228
* IEC 60269
* IEC 60297
* IEC 60309
* IEC 60320
* IEC 60364
* IEC 60446
* IEC 60559
* IEC 60601
* IEC 60870
* IEC 60870-5
* IEC 60870-6
* IEC 60906-1
* IEC 60908
* IEC 60929
* IEC 60958
* AES3
* S/PDIF
* IEC 61030
* IEC 61131
* IEC 61131-3
* IEC 61158
* IEC 61162
* IEC 61334
* IEC 61346
* IEC 61355
* IEC 61360
* IEC 61400
* IEC 61499
* IEC 61508
* IEC 61511
* IEC 61850
* IEC 61851
* IEC 61883
* IEC 61960
* IEC 61968
* IEC 61970
* IEC 62014-4
* IEC 62056
* IEC 62061
* IEC 62196
* IEC 62262
* IEC 62264
* IEC 62304
* IEC 62325
* IEC 62351
* IEC 62365
* IEC 62366
* IEC 62379
* IEC 62386
* IEC 62455
* IEC 62680
* IEC 62682
* IEC 62700

ISO/IEC standards|

* ISO/IEC 646
* ISO/IEC 2022
* ISO/IEC 4909
* ISO/IEC 5218
* ISO/IEC 6429
* ISO/IEC 6523
* ISO/IEC 7810
* ISO/IEC 7811
* ISO/IEC 7812
* ISO/IEC 7813
* ISO/IEC 7816
* ISO/IEC 7942
* ISO/IEC 8613
* ISO/IEC 8632
* ISO/IEC 8652
* ISO/IEC 8859
* ISO/IEC 9126
* ISO/IEC 9293
* ISO/IEC 9592
* ISO/IEC 9593
* ISO/IEC 9899
* ISO/IEC 9945
* ISO/IEC 9995
* ISO/IEC 10021
* ISO/IEC 10116
* ISO/IEC 10165
* ISO/IEC 10179
* ISO/IEC 10646
* ISO/IEC 10967
* ISO/IEC 11172
* ISO/IEC 11179
* ISO/IEC 11404
* ISO/IEC 11544
* ISO/IEC 11801
* ISO/IEC 12207
* ISO/IEC 13250
* ISO/IEC 13346
* ISO/IEC 13522-5
* ISO/IEC 13568
* ISO/IEC 13818
* ISO/IEC 14443
* ISO/IEC 14496
* ISO/IEC 14882
* ISO/IEC 15288
* ISO/IEC 15291
* ISO/IEC 15408
* ISO/IEC 15444
* ISO/IEC 15445
* ISO/IEC 15504
* ISO/IEC 15511
* ISO/IEC 15693
* ISO/IEC 15897
* ISO/IEC 15938
* ISO/IEC 16262
* ISO/IEC 17024
* ISO/IEC 17025
* ISO/IEC 18000
* ISO/IEC 18004
* ISO/IEC 18014
* ISO/IEC 19752
* ISO/IEC 19757
* ISO/IEC 19770
* ISO/IEC 19788
* ISO/IEC 20000
* ISO/IEC 21000
* ISO/IEC 21827
* ISO/IEC 23000
* ISO/IEC 23003
* ISO/IEC 23008
* ISO/IEC 23270
* ISO/IEC 23360
* ISO/IEC 24707
* ISO/IEC 24727
* ISO/IEC 24744
* ISO/IEC 24752
* ISO/IEC 26300
* ISO/IEC 27000
* ISO/IEC 27000-series
* ISO/IEC 27002
* ISO/IEC 27040
* ISO/IEC 29119
* ISO/IEC 33001
* ISO/IEC 38500
* ISO/IEC 42010
* ISO/IEC 80000

Related|

* International Electrotechnical Commission

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