Use specification and interface specification
Define users, patients, environments, training, key tasks and interface requirements.
Medical & healthcare
Connect use errors and interface design to patient safety
IEC 62366-1 addresses usability engineering related to medical device safety. Evaluate intended users, tasks, environments and hazard-related scenarios throughout interface development.
Source record updated:
Discuss your certification →Scope and applicability
Safety-related medical device usability engineering standard
It is a process standard, not a separate Korean sales authorization. Use its evidence in risk management and submissions, confirming edition, change impact and evaluation scope against applicable requirements.
Korean certification schemes and international standards are different. A translated guide does not extend a Korean certificate to other countries. Confirm the target market, product classification and current requirements with the relevant body.
Who this is for
- Medical software interface teams
- Device manufacturers preparing usability evidence
- Teams evaluating safety-related use errors
Documents to prepare
Hazard-related use scenarios
Link incorrect inputs, misunderstood alerts and misinterpreted outputs to the risk management file.
Evaluation and design change records
Document formative findings, improvements, summative participants, scenarios, judgments and remaining issues.
Preparation process
Define users, tasks and risks
Select representative environments and safety-related interface characteristics and scenarios.
Evaluate formatively and improve
Investigate difficulties and errors and verify interface, training and labeling changes.
Complete summative evaluation
Evaluate final-design scenarios and link results to risk and regulatory evidence.
Timing
User groups, recruitment, locations, tasks and design iterations affect duration. Reserve formative evaluation time before finalizing the interface.
Agency fees
External usability evaluation and testing
Separate quotation
No single Korean statutory certification fee is established by this standard's name alone. Confirm standard purchase, testing, assessment and product authorization costs separately.
Sources and references ↗Document automation and management cost KRW 300,000 per month. Expert services and certification body testing or assessment fees are separate. Specify supports preparation; the relevant authority or certification body makes the final decision.
Pricing and certification costs →Optional expert consulting
Expert review and consulting are optional, separately scoped services. Choose support for IEC 62366-1 based on your team's readiness and the evidence or assessment preparation you need.
- Confirm institutional testing, assessment and registration fees separately in the contract.
- Development fixes, clinical studies where applicable, security equipment and infrastructure operations may require separate budgets.
- Confirm internal staffing, travel, translation, VAT, surveillance and renewal costs in the quotation.
Questions and answers
Is this simply a UX satisfaction survey?
No. It addresses safety-related use errors and risk controls, with participants, scenarios and judgments linked to risk management.
Do professional-only devices need evaluation?
Professional users can also make errors under real environmental and workflow constraints. Scope evaluation around intended use.
Does every color change require a full repeat?
Assess effects on recognition, alerts, interpretation and safety, then choose activities based on documented impact.