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.
What You Need to Know? 👇
What are the key regulatory requirements for diagnostic ECG devices under FDA guidance?
Diagnostic ECG devices must comply with 21 CFR §870.2340 as Class II devices. Submissions require device description, predicate comparison, performance testing (preferably EC11 standard conformance), safety testing, proper labeling, and either Summary of Safety/Effectiveness or 510(k) Statement per regulations.
Which testing standards should be followed for ECG device performance validation?
The primary standard is ANSI/AAMI EC11-1991 for diagnostic electrocardiographs. For ST segment measurement capabilities, conform to relevant EC38 standard portions. Alternative standards acceptable if they meet/exceed EC11 requirements with proper justification and comparative analysis provided.
What environmental testing is required for portable ECG devices used outside hospitals?
Devices for transport environments need additional testing beyond standard hospital requirements. Ambulance use requires shock/vibration testing (IEC 68-2 series) and 20 V/m electromagnetic immunity (vs. standard 3 V/m). Aircraft/helicopter use requires specialized testing - contact FDA Division for guidance.
How should electromagnetic compatibility be demonstrated for ECG devices?
Three options: 1) Test data showing conformance to ANSI/AAMI EC38-1994 part 3.2.10, 2) Declaration of Conformity to IEC 601-1-2, or 3) Custom testing addressing emissions and immunity for all intended environments with proper justification for standard selection.
What devices are excluded from this diagnostic ECG guidance?
Excluded devices include: internal ECG data collection, interpretation/pattern recognition systems, fetal monitors, ambulatory monitoring devices, vectorcardiographs, pulse plethysmographic devices, and ECGs integrated into other medical devices like defibrillators or patient monitors.
What documentation format is recommended for ECG device test reports?
Test reports should include: detailed test protocol with setup/equipment/methods, clear data and results with labeled units and tables, and comprehensive analysis evaluating pass/fail criteria, test adequacy, and conclusions within the test scope per the guidance specifications.
What You Need to Do 👇
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