Usability IEC 62366

IEC 62366-1 assessment verifies that a usability engineering process has been applied to manage the risks arising from use errors of the medical device. The standard's basic approach is: a use error is not the user's fault but an outcome of the design, and must be prevented through design.

The purpose is to show that the device can be used safely by the intended user, in the intended use environment and use scenarios, and that use-error risk has been reduced to an acceptable level.

• Infusion pumps and injection devices
• Home-use medical devices (blood-pressure monitor, glucometer)
• Patient monitors and alarm systems
• Surgical devices and user interfaces
• Medical device software interfaces

• IEC 62366-1usability engineering in medical devices test
• IEC 62366-2
• ISO 14971
• IEC 60601-1-6
• ISO 13485medical device quality management system test
• ISO 11607end product sterile barrier packaging test

Use specification

The target user group, use environment and use scenarios are defined

Critical tasks

Tasks that, if performed incorrectly, could lead to harm are identified

Validation

Carried out with representative users, under realistic use conditions

• Usability test laboratory or simulated use environment
• Video and screen recording system
• Observation and data-collection tools
• Participant-management infrastructure

• The final, or equivalent-to-final, device and user interface
• Use specification and user-interface specification
• Risk management file and use-error analysis
• Instructions for use and training materials
• Access to a representative user group must be provided

Formative evaluations continue throughout development; the summative validation study takes several weeks, including planning and participant recruitment.

1. 1The use specification is prepared: user, environment, scenarios.
2. 2Safety-related user-interface characteristics are identified.
3. 3Known and foreseeable use errors are analysed.
4. 4Critical tasks are defined.
5. 5The user-interface specification and evaluation plan are prepared.
6. 6The design is refined through formative evaluations.
7. 7The summative validation study is conducted with representative users.
8. 8Use errors and difficulties are analysed with their root causes.

The acceptance criterion is that, in summative validation, no use error remains on critical tasks that leads to unacceptable risk. Every observed use error and difficulty is assessed through root-cause analysis; risk acceptability is determined under ISO 14971.

In the assessment, the nature of the error is decisive, not its count. A use error observed in a single participant but capable of causing serious harm is a more severe finding than a minor difficulty observed in many participants.

• Use specification and user profile
• Critical-task list and rationale
• Evaluation plan and participant information
• Observed use errors and difficulties
• Root-cause analyses
• Risk assessment and conclusion

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.

• MDR (EU) 2017/745
• Relationship with IEC 60601-1-6

The section below describes the field that the Usability IEC 62366 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.

• Electrical Safety IEC 60601
• EMC IEC 60601-1-2
• Software IEC 62304
• Sterility
• Bioburden
• Bioburden
• Endotoxin
• Cleaning Validation
• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity