Glossary · ISO and IEC standards for MedTech and pharma
IEC 62366-1
Also known as: IEC 62366-1:2015+A1:2020, EN 62366-1, Usability engineering for medical devices
IEC 62366-1 is the international standard for applying usability engineering to medical devices. It requires a process to analyze, specify, design and evaluate the user interface so that risks related to use, in particular use errors, are identified and controlled.
- Standards
- MDR
In one sentence
IEC 62366-1 sets the usability engineering process for medical devices: use specification, hazard-related use scenarios, formative and summative evaluation.
Example
A manufacturer of an autoinjector identifies hazard-related use scenarios such as injecting before removing the cap, tests early prototypes with patients in formative studies, and runs a summative evaluation with representative users on the final device and instructions for use.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
How it applies
- Use specification: Intended medical indication, patient population, user profiles, use environment and operating principle are defined first; they set the frame for the analysis.
- Hazard-related use scenarios: User interface characteristics related to safety and foreseeable use errors are identified and fed into the ISO 14971 risk analysis, including reasonably foreseeable misuse.
- User interface: The user interface includes the labeling and the instructions for use, not only hardware and screens. Information for safety counts as a risk control only if its effectiveness is evaluated.
- Evaluation: Formative evaluations during design; a summative evaluation shows that the user interface can be used safely. Guidance is in IEC/TR 62366-2.
- Link to other standards: For medical electrical equipment, the collateral standard IEC 60601-1-6 refers to IEC 62366-1; see IEC 60601-1.
- Technical documentation: The usability engineering file records the use specification, user interface specification, evaluation plans, protocols and results. Where the IFU is part of a risk control, its test results belong in this file.
Formative vs. summative evaluation
Formative evaluation explores the design while it can still change, with prototypes and small user groups, and is meant to find problems. Summative evaluation is performed on the final user interface with representative users and is meant to provide objective evidence that hazard-related use scenarios are handled safely. Only the summative evaluation is a validation of the user interface; formative results can't replace it.
Compared with the USA
The FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” (2016) uses the term human factors validation testing for what IEC 62366-1 calls summative evaluation, and it expects critical tasks to be covered.