IEC 60601-1-6 Usability Engineering Testing for Medical Devices
IEC 60601-1-6 specifies usability engineering requirements for medical electrical equipment. Compatible Electronics provides comprehensive usability testing to ensure your medical devices are safe and effective for their intended users.
What is IEC 60601-1-6?
IEC 60601-1-6 is the collateral standard addressing usability engineering for medical electrical equipment. It requires manufacturers to identify and mitigate use errors that could result in patient harm, incorporating principles from IEC 62366 medical device usability engineering.
Usability Engineering Process
Use Specification
- Intended users identification
- Use environments characterization
- User interface description
- Clinical functions documentation
Use-Related Risk Analysis
- Hazard identification
- Use error scenarios
- Risk evaluation
- Risk control measures
Formative Evaluation
- Prototype testing
- User interface refinement
- Iterative design improvements
- Critical task evaluation
Summative Evaluation
- Final design validation
- Representative user testing
- Use error evaluation
- Safety verification
Key Usability Requirements
User Groups
- Professional healthcare providers
- Home healthcare users
- Patients and caregivers
- Service and maintenance personnel
Use Environments
- Professional healthcare facilities
- Home healthcare environments
- Emergency and transport settings
- Environmental conditions
User Interface Elements
- Controls and displays
- Alarms and indicators
- Labeling and instructions
- Software user interfaces
Critical Tasks
- Safety-critical operations
- Normal use procedures
- Abnormal conditions response
- Maintenance and setup
Testing We Perform
Usability Test Protocol Development
Creation of comprehensive test protocols that evaluate critical tasks, use scenarios, and potential use errors with representative users.
User Testing Sessions
Facilitated testing with representative users performing critical tasks under realistic conditions with detailed observation and documentation.
Use Error Analysis
Systematic evaluation of observed use errors, near-misses, and difficulties to assess safety implications and design effectiveness.
Documentation Support
Comprehensive usability engineering file documentation supporting regulatory submissions and design verification activities.
Integration with IEC 62366
Harmonized Approach
IEC 60601-1-6 references IEC 62366 for usability engineering principles. Our testing integrates both standards, ensuring comprehensive usability evaluation that meets FDA and international regulatory expectations.
IEC 62366-1 is now the primary usability engineering standard referenced by IEC 60601-1-6
Standards We Test To
International
- IEC 60601-1-6 Ed. 3.0 (2010)
- IEC 60601-1-6 Ed. 3.1 (2013)
- IEC 62366-1 (2015)
European
- EN 60601-1-6 (European harmonized)
- EN 62366-1 (European harmonized)
- MDR Annex I requirements
North America
- AAMI/IEC 60601-1-6
- FDA guidance on human factors
- AAMI HE75 (human factors engineering)
Related Standards
- IEC 62366-2 (formative evaluation)
- ISO 14971 (risk management integration)
- IEC 60601-1-8 (alarms usability)
Need Usability Testing?
Contact us for comprehensive medical device usability engineering and testing services.
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