Diagnostic Electrocardiograph Devices - Performance Testing and Safety Requirements
This guidance applies to diagnostic electrocardiographs covered by ANSI/AAMI EC11-1991 standard, including devices that detect and measure ST segment level changes without alarms. It specifically excludes devices collecting ECG from non-external locations, interpretation devices, fetal monitors, ambulatory monitors, vectorcardiographs, and ECGs integrated into other medical devices.
Recommended Actions
- Prepare comprehensive device description including all required specifications and intended use
- Conduct performance testing either through comparison or standards conformance
- Complete environmental and safety testing appropriate for intended use environment
- Prepare EMC testing documentation based on chosen approach
- Ensure software documentation meets requirements based on level of concern
- Compile labeling documentation meeting all regulatory requirements
- Document comparison to predicate device with emphasis on similarities and differences
- Prepare regulatory submission documents including Safety and Effectiveness Summary
- For ST segment measurement features, ensure conformance to EC38 standard requirements
- Follow test report format guidelines for all testing documentation
Key Considerations
Non-clinical testing
- Performance testing through either:
- Comparison testing with predicate device
- Conformance to EC11 standard
- Conformance to equivalent standards
- ST segment measurement must conform to applicable portions of EC38 standard
- Environmental testing for expected use conditions
- Electrical safety testing
- EMC testing for emissions and immunity
Software
- Documentation requirements based on level of concern (minor to moderate)
- Follow “Guidance for Content of Premarket Submissions for Software Contained in Medical Devices”
Labelling
- Must conform to labeling regulations in 21 CFR 807.87(e)
- Include EC11 standard labeling requirements if applicable
Biocompatibility
- Material descriptions required for all patient contacting materials
Safety
- Electrical safety testing required
- EMC testing for interference and immunity
- Environmental hazard testing
Other considerations
- Device description including intended use, contraindications, specifications
- Comparison to predicate device
- Regulatory requirements including Summary of Safety and Effectiveness or 510(k) Statement
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ANSI/AAMI EC11-1991: Diagnostic Electrocardiographic Devices
- ANSI/AAMI EC38-1994: Ambulatory Electrocardiographs
- ANSI/AAMI ES1-1993: Safe current limits for electromedical apparatus
- IEC 60601-1-2: Medical Electrical Equipment - EMC Requirements and Tests
- IEC 68-2-6: Environmental Testing - Vibration
- IEC 529: Classification of Degrees of Protection Provided by Enclosures
Original guidance
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