Execute detailed testing procedures ensuring reproducible performance verification and validation results.
Standard | Title | Applicable Sections |
---|---|---|
ISO 81060-2 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type | Accuracy testing methodology |
ANSI/AAMI/ISO 81060-2 | Non-invasive sphygmomanometers - Part 2: Clinical investigation | US-specific requirements |
IEC 60601-1 | Medical electrical equipment - General requirements for basic safety and essential performance | Electrical safety requirements |
IEC 62304 | Medical device software - Software life cycle processes | Software verification requirements |
Equipment | Model/Type | Accuracy Requirement | Calibration Interval |
---|---|---|---|
Reference Sphygmomanometer | Mercury or aneroid, calibrated | ±1 mmHg | 6 months |
Pressure Simulator | Fluke Biomedical BP Pump 2 | ±0.1 mmHg | 12 months |
Environmental Chamber | Temperature/humidity controlled | ±1°C, ±3% RH | 12 months |
Stopwatch | Digital, calibrated | ±0.1 seconds | 12 months |
How detailed should test procedures be in verification protocols?
What should I do if my device fails protocol testing?
How do I handle protocol deviations during testing?
What statistical analysis should be included in verification protocols?
How do I ensure test method validity for custom procedures?
What equipment qualification is needed for verification testing?