The ISO 9241 Standards
The ISO 9241 is an entire family of standards originally from the “Ergonomic requirements for office work with visual display units”. Meanwhile, the applicability of ISO 9241 has further developed to every form of product.
Standards of the ISO 9241 family
The members of this standard include:
- ISO 9241-13 user guide
- ISO 9241-14 dialoguing management via menus
- ISO 9241-110 Dialogue principles (which replaced ISO 9241-10)
- ISO 9241-112 principles of information representation
- ISO 9241-125 Visual information presentation
- ISO 9241-143 form dialogs
- ISO 9241-151 browser-based user interface
- ISO 9241-154 voice response systems
- ISO 9241-161 user interface elements
- ISO 9241-171 Accessibility of user interfaces
- ISO 9241-210 describes the process for the design of usable interactive systems
Note that some of these standards in the ISO 9241 family are not yet released:
- The 9241-112 is a first draft of the new standard “principles of information presentation and general recommendations”. Here principles and general recommendations are given for the presentation of information ABOUT ALL MODALITIES, i.e. seeing, hearing, feeling (smelling, tasting).
- The 9241-125 is a first draft of the new standard “recommendations for visual presentation”.
The 9241-112 and 9241-125 together form as the successor to the ISO 9241-12.
The 9241-161 is only found as a draft standard. The standard is expected to be released in the first quarter of 2015. The draft will only be adapted (if at all) to editorial “small stuff”.
Contents of ISO 9241 and relation to IEC 62366
While the IEC 62366 is a standard process that provides no specific requirement for the design of user-product interfaces, the ISO 9241 has very specific design guidelines. These relate to the design of web applications as well as designing forms, command-driven user-interfaces-product, or the design of menus.
But the principles that the ISO 9241 describes, go far beyond office work and display devices. They can be largely due to all the interactive systems and thus transferred to medical devices. If the medical device is standalone software, then it can be done almost completely.
However, in contrast to IEC 62366, ISO 9241 does not consider the aspect of risk management and the safety of users and patients. Nevertheless, the statement is true that ready products, increase or decrease the risk for the safety of users and patients.
The ISO 9241 also describes the specific methodology by which manufacturers can derive the real customer requirements systematically(!). The Audit guarantor describes this impressive method already in four video training sessions, also by means of concrete examples.
The IEC 62366 refers to ISO 9241 but without concrete demands to take over from them. Unfortunately, the IEC 62366 has also adopted the definitions of ISO 9241 for example the concept of ‘usability’ is unchanged.
We have a poster that lists these standards and describes how to integrate the usability oriented development process in accordance with IEC 62366 in the development process: