In addition to knowledge of methods and industry expertise, knowledge of relevant rules and standards is one of the fundamental preconditions of effectively assessing user experience (UX). We follow these standards within the field of user experience not to ensure every product results in the same user experience, but rather, to leverage product and research design conventions for dialogue, user guidance, menu design or the presentation of information among other facets of product interfaces.
Below, we present a brief overview of the UX standards and guidelines that are most relied upon by designers in two key fields: software and website development and medical products.
Software & Web development
One of the most important standards in the field of software and web development is the ISO 9241 standard, ‘Ergonomics of human-system interaction‘. Though consisting of numerous parts, some still in draft form, there are four relevant to the design and evaluation of software and websites:
• Part 11: Guidance on Usability
• Part 110: Dialogue Principles
• Part 151: Guidance on World Wide Web User Interfaces
• Part 210: Human-centered Design for Interactive Systems
In addition to website usability, website accessibility is also governed by an established guideline. The Web Content Accessibility Guideline (WCAG) 2.0 delineates a large number of recommendations to improve the accessibility of web content for those with vision, speech, hearing or mobility impairments; as well as learning or other types of disabilities.
Though medical devices are hardly comparable to web development in most regards, there is one important commonality: usability. Usability is as much a component to designing a medical device that is safe and effective to use as it is to designing a website that can be effectively navigated by users.
The following list represents a few of the key standards and guidance documents relevant to the development of medical devices at the national and international levels:
• The standard IEC 60601-1-6 (DIN EN 60601-1-6 in German) defines the process by which medical electronic equipment must mitigate risk caused by usability issues. The standard outlines processes for analyzing, designing and validating the usability of medical electronic equipment.
• The standard IEC 62366:2007 defines the process by which medical devices must mitigate risk caused by usability issues. Like IEC 60601, this standard outlines processes for analyzing, designing and validating usability of a medical device.
• The draft FDA Guidance document titled “Medical Device Use-Safety – Incorporating Human Factors Engineering into Risk Management” outlines how to integrate and document the human factors engineering process in the risk management process. This guidance outlines the necessary documentation for medical device approval by the Food and Drug Administration (FDA) for the US market.
• The Medical Devices Directive 93/42 EEC outlines the requirements for getting medical devices and products released for European markets. This directive covers a wide array of products.
These standards and directives contain crucial knowledge, especially in the medical device space. As usability gains traction in the regulatory space, these standards and directives will garner more attention.