In this article we are going to explore the fascinating world of IEC 62366. From its origins to its relevance today, IEC 62366 has played a crucial role in various aspects of society. Over the years, IEC 62366 has been the subject of study and interest by experts and fans, who have tried to unravel its mysteries and understand its impact on our daily lives. Through this article, we will delve into the history, evolution and meaning of IEC 62366, with the purpose of shedding light on this exciting and relevant topic.
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.
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.
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]