Usability — IEC 62366-1

IEC 62366-1 defines the usability engineering process to be followed for managing risks arising from use error in medical devices. The process begins with defining the use environment and user profile; formative studies are carried out during design and a summative study at the end.

The purpose is to reduce, at the design stage, the harm that could arise from misuse of the device. Use error underlies a significant share of medical device incidents, and this process directly targets it.

• Infusion pumps and injectors
• Medical devices for home use
• Patient monitors and alarmed devices
• Diagnostic devices with a user interface
• Mobile health applications

• IEC 62366-1usability engineering in medical devices test

Use specification

User profiles, use environment and use scenarios

Critical tasks

Identifying tasks that could cause harm if performed incorrectly

Study type

Formative study during design, summative study at the end

Participants

With participants representing each user group, in an environment reflecting real use conditions

• Usability observation room and recording system
• Simulation setups mimicking the use environment
• Task recording and timing tools
• Participant interview and questionnaire tools

• The device must be supplied in its final design form for the summative study.
• The instructions for use and training materials must be provided in their final form.
• User profiles and the use environment definition must be shared.
• The critical task list and its link to the risk analysis must be provided.
• The interface software version must be recorded.

Formative studies are repeated throughout design. The summative study, together with recruiting participants and running sessions, is a process of several weeks.

1. 1The intended use, user profiles and use environment are defined.
2. 2Hazards related to the user interface and critical tasks are identified.
3. 3The usability engineering plan is prepared.
4. 4Formative studies are carried out during design and the design is updated.
5. 5The summative study is planned with the final design.
6. 6Participants perform the critical tasks under real use conditions.
7. 7Observed use errors and difficulties are analysed and reported.

The acceptance criterion is selected from the relevant section of the standard according to the device's contact type (surface, externally communicating, implant), contact duration and intended use. The assessment relies not on a single test result but on the biological evaluation plan carried out under ISO 10993-1; this page therefore gives no fixed limit.

The assessment relies on whether observed use errors lead to unacceptable risk. Not every error is a non-conformity; its root cause is analysed and whether it can be addressed through design, instructions or training is decided within the risk management process.

• Device identification, model and lot number, if any
• Device contact type, duration and intended use
• Standard and section applied
• Extraction or sample preparation conditions
• Cell line, test system or test rig used
• Controls and their results
• Observations, measurement results and assessment
• A statement that the result applies only to the specimen submitted for testing

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

• EU 2017/745 Medical Device Regulation (MDR)
• Medical Device Regulation (Türkiye)
• ISO 14971 (risk management for medical devices)
• ISO 13485 (medical devices — quality management system)

The section below describes the field that the Usability test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

• Cytotoxicity
• Sensitisation
• Irritation
• Systemic Toxicity
• Genotoxicity
• Implantation
• Haemocompatibility
• Sterility
• Packaging Validation
• Accelerated Ageing
• Electrical Safety
• Medical EMC