IEC 62366
medical devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
- Application of usability engineering to medical devices is an
international standard
international standard is a technical standard developed by one or more international standards organization, standards organizations. International standards are available for consideration and use worldwide. The most prominent such organization ...
published by the
International Electrotechnical Commission
The International Electrotechnical Commission (IEC; in French: ''Commission électrotechnique internationale'') is an international standards organization that prepares and publishes international standards for all electrical, electronic and ...
(IEC). The standard specifies usability requirements for the development of
medical devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
. It has been adopted as national standards and therefore can be used as a
benchmark
Benchmark may refer to:
Business and economics
* Benchmarking, evaluating performance within organizations
* Benchmark price
* Benchmark (crude oil), oil-specific practices
Science and technology
* Benchmark (surveying), a point of known elevati ...
to
comply with regulatory requirements.
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. 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.
See also
*
International Electrotechnical Commission
The International Electrotechnical Commission (IEC; in French: ''Commission électrotechnique internationale'') is an international standards organization that prepares and publishes international standards for all electrical, electronic and ...
(IEC)
*
List of IEC standards
*
IEC 60601
IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, as of ...
References
External links
*
{{List of International Electrotechnical Commission standards
#62366
Regulation of medical devices