Usability Engineering File: [Device name and model]
The usability engineering file for one medical device, structured on
IEC 62366-1:2015 with Amendment 1:2020 (Medical devices, Part 1:
Application of usability engineering to medical devices, consolidated
edition 1.1, June 2020). It records the use specification, the user
interface characteristics related to safety, known use problems,
hazard-related use scenarios, the user interface specification, the
evaluation plan, formative evaluations and the summative evaluation.
The process focuses on use errors that can lead to harm in normal use;
it does not try to prevent deliberate abnormal use. Replace every
[bracketed] value and every row marked Example. This is a
documentation format, not regulatory or medical advice: check the
current official texts, the expectations of your target markets and a
qualified human factors and regulatory professional.
Document control
| Field | Value |
|---|
| Document ID | [UEF-NNN] |
| Device | [Name, model, variants] |
| User interface version | [Hardware, software and labelling versions evaluated] |
| Linked records | [Risk management file ID, design and development file ID] |
| Version | [0.1] |
| Status | [Draft / In review / Approved] |
| Owner | [@usability-lead] |
| Last updated | YYYY-MM-DD |
| Classification | [Internal / Confidential] |
Approvals
| Role | Name | Decision | Date |
|---|
| Usability engineering lead | [@name] | [Approved] | YYYY-MM-DD |
| Risk management lead | [@name] | [Approved] | YYYY-MM-DD |
| Clinical expert | [@name] | [Approved] | YYYY-MM-DD |
Revision history
| Version | Date | Author | Change summary |
|---|
| 0.1 | YYYY-MM-DD | [@name] | Use specification and known use problems |
| 0.6 | YYYY-MM-DD | [@name] | Example: Formative evaluations FE-01 to FE-03 added |
| 1.0 | YYYY-MM-DD | [@name] | Example: Summative evaluation USAB-07 report and conclusion |
Contents
- Use specification (cl. 5.1)
- User interface characteristics related to safety and potential use errors (cl. 5.2)
- Known or foreseeable hazards and hazardous situations (cl. 5.3)
- Hazard-related use scenarios (cl. 5.4)
- Selection for summative evaluation (cl. 5.5)
- User interface specification (cl. 5.6)
- User interface evaluation plan (cl. 5.7)
- Formative evaluations (cl. 5.8)
- Summative evaluation (cl. 5.9)
- Process, tailoring and user interface of unknown provenance (cl. 4, Annex C)
- Traceability matrix
- Glossary and references
1. Use specification (cl. 5.1)
| Item | Value |
|---|
| Intended medical indication | Example: Continuous or intermittent intravenous infusion of fluids and medicines |
| Patient population | Example: Adults and children above 10 kg in hospital |
| Part of the body or tissue | Example: Venous access through a standard administration set |
| Operating principle | Example: Volumetric peristaltic pump with drug library and dose limits |
| Use environment | Example: Intensive care units, general wards, in-hospital transport; noise up to ward alarm levels, variable lighting, gloves worn |
| User group | Description | Training assumed | Main tasks |
|---|
| UG-01 (Example) | Intensive care nurses | Device training at induction, frequent use | Program, titrate, respond to alarms |
| UG-02 (Example) | General ward nurses | Device training at induction, occasional use | Program standard infusions, respond to alarms |
| UG-03 (Example) | Biomedical technicians | Service training | Set-up, drug library upload, preventive maintenance |
2. User interface characteristics related to safety and potential use errors (cl. 5.2)
| ID | User interface characteristic | Potential use error | Error type |
|---|
| UIC-01 (Example) | Numeric keypad with decimal point | Enters 10 times the intended rate | Action slip |
| UIC-02 (Example) | Unit selector (mL/h, mg/kg/min) | Programs in the wrong unit | Cognition, mistake |
| UIC-03 (Example) | Administration set loading door | Loads the set without closing the clamp, free flow | Action, omission |
| UIC-04 (Example) | Occlusion alarm tone and display | Alarm not noticed in a noisy ward | Perception |
| UIC-05 (Example) | Drug library search list | Selects a drug with a similar name | Perception, confusion |
3. Known or foreseeable hazards and hazardous situations (cl. 5.3)
| ID | Source | Known use problem | Hazard (RMF) |
|---|
| KUP-01 (Example) | Published infusion error studies | Decimal and tenfold programming errors | HZ-04 |
| KUP-02 (Example) | Field safety notices for similar pumps | Free flow during set loading | HZ-07 |
| KUP-03 (Example) | Own complaints, previous model | Occlusion alarm missed in noisy ward | HZ-06 |
| KUP-04 (Example) | Medication safety reports | Look-alike drug names in libraries | HZ-04 |
4. Hazard-related use scenarios (cl. 5.4)
| ID | Task sequence | Use error | Hazardous situation | Harm | Severity (RMF) |
|---|
| HRUS-01 (Example) | Select drug, enter rate, confirm, start | Rate entered 10 times too high | Over-dose delivered | Serious injury | 4 |
| HRUS-02 (Example) | Open door, load set, close door, open clamp | Clamp opened before the set is seated | Uncontrolled free flow | Serious injury | 4 |
| HRUS-03 (Example) | Hear alarm, identify occlusion, clear it, restart | Alarm not noticed for 10 min | Therapy interrupted | Serious injury for critical drugs | 4 |
| HRUS-04 (Example) | Search library, select drug | Look-alike drug selected | Wrong limits applied | Serious injury | 4 |
| HRUS-05 (Example) | Upload drug library | Outdated library file uploaded | Wrong limits applied | Serious injury | 4 |
5. Selection for summative evaluation (cl. 5.5)
| Scenario | Included? | Reason |
|---|
| HRUS-01 (Example) | Yes | Serious harm, primary programming task |
| HRUS-02 (Example) | Yes | Serious harm, known field problem |
| HRUS-03 (Example) | Yes | Serious harm, own complaint history |
| HRUS-04 (Example) | Yes | Serious harm |
| HRUS-05 (Example) | No | Library upload software checks version and signature (SRS-075); error verified impossible by test ST-260, argued in the risk file |
6. User interface specification (cl. 5.6)
| ID | Requirement | Addresses | Verification |
|---|
| UIS-01 (Example) | Rates above the soft limit need a second confirmation screen showing the value in large digits | HRUS-01 | USAB-07 task 3, ST-230 |
| UIS-02 (Example) | The pump door cannot close unless the anti-free-flow clip is engaged | HRUS-02 | Design verification VER-140, USAB-07 task 1 |
| UIS-03 (Example) | High-priority alarm volume adjustable but never below a set minimum, with flashing light visible from 4 m | HRUS-03 | Alarm test, USAB-07 task 5 |
| UIS-04 (Example) | Drug names in the library shown with tall-man lettering for look-alike pairs | HRUS-04 | USAB-07 task 2 |
| UIS-05 (Example) | Quick reference card covers loading and alarm response | HRUS-02, HRUS-03 | Labelling review |
7. User interface evaluation plan (cl. 5.7)
7.1 Formative evaluation plan
| ID | Purpose | Method | Stage | Participants |
|---|
| FE-01 (Example) | Explore programming flows | Cognitive walkthrough with paper prototypes | Concept | 6 nurses |
| FE-02 (Example) | Compare two confirmation screen designs | Simulated use on a prototype | Detailed design | 8 nurses |
| FE-03 (Example) | Check alarm perception in ward noise | Simulated ward, recorded background noise | Pre-verification | 10 nurses |
7.2 Summative evaluation plan
| Item | Plan |
|---|
| Study ID | USAB-07 (Example) |
| Scenarios | HRUS-01 to HRUS-04 |
| Participants | Example: 15 per user group: UG-01 15, UG-02 15, UG-03 15, total 45 (UG-03 performs set-up and HRUS-02 tasks only) |
| Training | Example: Same training as real users receive, with a gap of at least 1 day before the session to allow for training decay |
| Environment | Example: Simulated ward with background noise and realistic lighting |
| Device | Production-equivalent units, released software and final labelling |
| Data collected | Observed use errors, close calls, use difficulties, task completion, participant comments in an interview after the tasks |
| Analysis | Root cause analysis of every use error and close call; assessment of residual risk in the risk management file |
| Acceptance | No use error on a selected scenario whose residual risk is judged not acceptable after root cause analysis |
Participant numbers: check the expectations of each target market. The
US FDA guidance Applying Human Factors and Usability Engineering to
Medical Devices (issued 3 August 2026) recommends, in general, at least
15 participants from each distinct user population for human factors
validation testing, possibly more for some device types; check the
current text before planning.
8. Formative evaluations (cl. 5.8)
| ID | Date | Key findings | Design change | Linked requirement |
|---|
| FE-01 (Example) | YYYY-MM-DD | 4 of 6 nurses looked for the unit selector after typing the rate | Unit chosen before rate entry | UIS-01 |
| FE-02 (Example) | YYYY-MM-DD | Design B caught 7 of 8 simulated tenfold entries, design A caught 3 of 8 | Design B adopted | UIS-01 |
| FE-03 (Example) | YYYY-MM-DD | 3 of 10 nurses did not notice the alarm within 2 min at minimum volume | Minimum volume raised, light added | UIS-03 |
9. Summative evaluation (cl. 5.9)
9.1 Results by scenario
| Scenario | Participants | Use errors | Close calls | Use difficulties |
|---|
| HRUS-01 (Example) | 30 (UG-01, UG-02) | 1 | 2 | 3 |
| HRUS-02 (Example) | 45 (all groups) | 0 | 1 | 4 |
| HRUS-03 (Example) | 30 (UG-01, UG-02) | 0 | 0 | 2 |
| HRUS-04 (Example) | 30 (UG-01, UG-02) | 1 | 1 | 1 |
9.2 Root cause analysis
| Observation | Scenario | Participant | Root cause | Consequence for risk | Action |
|---|
| OBS-01 (Example): tenfold rate confirmed on the confirmation screen | HRUS-01 | P-12 (UG-02) | Participant read the drug name, not the rate, on the confirmation screen | The rate was above the hard limit, so the pump refused it (SRS-052); for a drug with wider limits the error could reach the patient, residual risk reviewed in RMF HZ-04 | Rate moved to top of screen, retested in USAB-07b with 15 UG-02 participants: 0 use errors |
| OBS-02 (Example): look-alike drug selected | HRUS-04 | P-27 (UG-01) | Search list sorted by recent use placed the wrong drug first | Limits of the wrong drug were in a similar range; harm judged possible | Recent-use sorting removed, retested in USAB-07b: 0 use errors |
| OBS-03 (Example): close call, clamp almost opened early | HRUS-02 | P-38 (UG-03) | Habit from previous pump model | Anti-free-flow clip prevented flow | No change; covered by UIS-02 design control |
9.3 Conclusion
[State whether the user interface can be used safely for the intended
use, which residual use-related risks remain, and where they are
disclosed.] Example: After the changes verified in USAB-07b, no use
error remained on any selected scenario; residual use-related risks are
documented in the risk management file and disclosed in the
instructions for use.
10. Process, tailoring and user interface of unknown provenance (cl. 4, Annex C)
| Item | Value |
|---|
| Process procedure | [QMS procedure ID] |
| Tailoring of effort (cl. 4.3) | Example: Full process for the new pump user interface; reduced process for the unchanged administration set labelling, justified by 5 years of complaint data |
| Information for safety | Example: Warnings on free flow and alarm volume in the instructions for use, with their effectiveness evaluated in USAB-07 |
| User interface of unknown provenance (Annex C) | [None / which parts, and the evidence reviewed] |
| Accompanying documentation and training evaluated | [Yes / No, study IDs] |
11. Traceability matrix
| Scenario | Hazard (RMF) | UI characteristic | Requirement | Formative | Summative | Residual risk |
|---|
| HRUS-01 (Example) | HZ-04 | UIC-01, UIC-02 | UIS-01 | FE-01, FE-02 | USAB-07, USAB-07b | Acceptable |
| HRUS-02 (Example) | HZ-07 | UIC-03 | UIS-02, UIS-05 | FE-02 | USAB-07 | Acceptable |
| HRUS-03 (Example) | HZ-06 | UIC-04 | UIS-03, UIS-05 | FE-03 | USAB-07 | Acceptable |
| HRUS-04 (Example) | HZ-04 | UIC-05 | UIS-04 | FE-01 | USAB-07, USAB-07b | Acceptable |
12. Glossary and references
| Term | Working meaning in this file |
|---|
| Use error | An action or lack of action by the user that leads to a result different from what the manufacturer intended or the user expected |
| Close call | A use error that almost happened, or was caught and corrected before it caused a result |
| Use difficulty | A task the user completed with noticeable effort, hesitation or help |
| Hazard-related use scenario | A sequence of tasks in which a use error could lead to a hazardous situation |
| Formative and summative evaluation | Evaluation during design to find problems, versus evaluation of the final user interface to show it can be used safely |
Standard and licence note
Structure aligned with IEC 62366-1:2015+AMD1:2020 (consolidated edition
1.1, published 2020-06-17; stability date 2028 on the IEC webstore,
checked October 2026). Clause numbers are given for orientation only.
All wording, tables, IDs and examples are original; no text, table or
definition is reproduced from the standard. The device, participants
and results are fictional examples. This template is not regulatory or
medical advice: check the current official texts, the expectations of
your target markets and a qualified human factors and regulatory
professional.