Plan systematic laboratory testing framework verifying device specifications and validating user needs.
Subsystem ID | Subsystem Requirement | Test ID | Testing Required | Acceptance Criteria |
---|---|---|---|---|
SS-001 | Heart rate accuracy ±3 bpm (60-180 bpm range) | VT-001 | Optical sensor accuracy testing against reference ECG | Measured HR within ±3 bpm of reference for 95% of measurements |
SS-002 | Arrhythmia detection sensitivity ≥95% | VT-002 | Algorithm testing with known arrhythmia signals | Detect ≥95% of atrial fibrillation episodes in test dataset |
SS-003 | Battery life ≥7 days continuous monitoring | VT-003 | Power consumption measurement under continuous use | Average power consumption ≤5mW during monitoring mode |
SS-004 | Wireless range ≥10 meters line-of-sight | VT-004 | Bluetooth transmission range testing | Maintain connection at 10m distance with <1% packet loss |
SS-005 | Water resistance IPX7 rating | VT-005 | Immersion testing per IEC 60529 | No water ingress after 30 minutes at 1m depth |
UN ID | User Need | Test ID | Testing Required | Acceptance Criteria |
---|---|---|---|---|
UN-001 | Accurately monitor heart rate during daily activities | VL-001 | Real-world activity simulation testing | HR accuracy maintained during walking, running, and stationary activities |
UN-002 | Detect irregular heart rhythms and alert user | VL-002 | Integrated arrhythmia detection validation | System detects AF episodes and delivers alerts within 30 seconds |
UN-003 | Provide continuous monitoring without frequent charging | VL-003 | Extended wear testing simulation | Device operates ≥7 days with typical usage patterns |
UN-004 | Sync data reliably with smartphone app | VL-004 | End-to-end data transmission validation | ≥99% successful data synchronization under normal use conditions |
How do I determine what performance characteristics need testing?
What's the difference between verification and validation in performance testing?
How do I choose appropriate test methods when standards don't exist?
What sample sizes are needed for performance testing?
How should I handle test failures during performance testing?
Can I use the same test data for both verification and validation?