What is EN 62366?

IEC 62366 is the international standard that covers the application of usability engineering to medical devices. This standard helps medical device manufacturers consider human factors by offering a standardized process for analyzing, specifying, developing, and evaluating the usability of their medical device.

What is the latest version of IEC 62366?

IEC 62366-1:2015/Amd 1:2020.

What is usability medical devices?

Medical device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

What is the difference between IEC and ISO?

ISO standards are standards developed by the standardisation institute ISO, and IEC standards are developed by the International Electrotechnical Commission (IEC). EN standards are usually ISO or IEC standards that the European Commission has harmonised.

What IEC 82304?

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers.

What is the latest version of IEC 62304?

The second version of IEC 62304 is still in draft. It has been in this state for five years, since the publication of the amendment 1. We already had a draft version in 2019. A new draft version is, again, in public review (or has been in public review in your country) under the name IEC CDV 62304:2021.

What is meant by usability engineering?

Usability engineering is a professional discipline that focuses on improving the usability of interactive systems. It draws on theories from computer science and psychology to define problems that occur during the use of such a system.

What is IEC EN?

EN IEC is the european implementation of the IEC standard. There’s EN standards which are not IEC or ISO implementation (pure EN, for example EN 13060 on small steam sterilizers). Standards are voluntary. Directives are legislations, mandatory.

Why IEC standard is required?

IEC International Standards are essential for quality and risk management; they help researchers understand the value of innovation and allow manufacturers to produce products of consistent quality and performance.

What IEC 80001?

IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization.