Table 2.
The 9 quality principles (predominantly based on ISO 25010, with supporting sources also listed).
| Quality principle | Description | (Sub) Section of ISO/IECa 25010 [46] | Supporting sources |
| Practicality | High-quality software must be flexible enough to be used for the intended purpose and, if possible, beyond it, to cover the widest possible range of use and application contexts. | 4.1.3 satisfaction; 4.1.5 context coverage; 4.2.1 functional suitability; 4.4.11 stated purpose. | [35,37,38,55-64] |
| Risk adequacy | It must be possible to use software in a risk-appropriate manner without exposing the user or his or her environment to unreasonable health, social, or economic risks. | 4.1.4 freedom from risk (economic, health and safety, and environmental risk mitigation). | [55,56,65,66] |
| Ethical soundness | Development, provision, operation, and use must be ethically innocuous to prevent discrimination and stigmatization and to provide fair access. | 4.2.4.6 accessibility | [37,38,56,62,67,68] |
| Legal conformity | The legal conformity (eg, with regard to medical device law, professional codes of conduct, data protection laws, laws on the advertising of therapeutic products) for development, provision, operation, and use must be guaranteed for the protection of all parties involved (eg, providers, store operators, and users). | —b | [9,19,35,37,38,55,56,61,69-73] |
| Content validity | The content presented and used must be valid and trustworthy. | —c | [8,9,19,38,40,56,59-62,73-76] |
| Technical adequacy | Development, operation, and use need to be appropriately adapted to the capabilities of the technology and the current state-of-the-art to ensure sustainability in terms of maintainability, portability, interoperability, and compatibility. | 4.2.3 compatibility; 4.2.5 reliability; 4.2.7 maintainability, and 4.2.8 portability | [40,66,73,77] |
| Usability | The software must have a high degree of usability appropriate for its target groups, that is, it must be user-friendly and easy to use, taking into account the relevant circumstances and conditions. This can facilitate fair and sustainable use that is also convenient and contributes to user satisfaction. | 4.1.3.4 comfort; 4.2.4 usability; 4.2.8.1 adaptability. | [40,73,78] |
| Resource efficiency | Elements for resource-efficient operation and use should be taken into account during development. | 4.1.2 efficiency and 4.2.2 performance efficiency (including time behavior, resource utilization, and capacity) | [65,73] |
| Transparency | Full transparency regarding the aforementioned criteria serves as a basis for software evaluations as well as for individual and collective usage decisions. | —c | [9,19,35,66,73] |
aISO/IEC: International Organization for Standardization/International Electrotechnical Commission.
bNo longer covered in ISO/IEC 25010, but was part of ISO/IEC 9126-1:2001 [69], which 25010 revises.
cNot covered in ISO/IEC 25010.