CTS / CTQ Classification

Every requirement classified per boundary condition — overrides require e-signature

Critical-to-Safety
112
94% verified · 6% in progress
Critical-to-Quality
121
88% verified · 12% in progress
Standard
195
83% verified
Risk distribution
High / Medium / Low by classification
Requirement register
Statement → class → standard → boundary condition → coverage → result
IDStatementDomainClassRiskStandardBCCoverageResult
REQ-1058System shall deliver backup ventilation within 4.0s of apnea detection
SW
CTS
HighISO 80601-2-12BC-06100%
Fail
REQ-1042Blower shall achieve setpoint pressure within ±2 cmH2O
HW
CTS
HighISO 80601-2-12BC-02100%
Pass
REQ-1103FiO2 sensor drift shall not exceed 1% / 24h
HW
CTS
HighISO 80601-2-12BC-03100%
Pass
REQ-2201Alarm shall be audible ≥ 65 dBA at 1m distance
HW
CTQ
MediumIEC 60601-1-8BC-04100%
Pass
REQ-3009Battery shall provide ≥ 45 min transport runtime at nominal load
HW
CTQ
MediumBenchmarkBC-05100%
Pass
REQ-1120UI shall lock ventilation params during patient session unless unlocked
SW
CTS
HighIEC 62366-1BC-0892%
Running
REQ-1131Security patches shall be applied within 30 days of release
SW
CTS
HighIEC 81001-5-1BC-0866%
Pending
REQ-0431System shall log every parameter change with timestamp and user
SW
CTS
HighFDA 21 CFR Part 11—100%
Pass
REQ-2145Trigger sensitivity response ≤ 100 ms
SW
CTS
HighISO 80601-2-12BC-09100%
Pass
REQ-3140PEEP shall be maintained within ±1 cmH2O across cycles
HW
CTQ
MediumBenchmarkBC-0788%
Running
REQ-4020Humidifier shall reach 37°C within 15 min from cold start
HW
CTQ
LowISO 8185BC-10100%
Pass
REQ-4051Touchscreen shall register input within 80 ms
HW
CTQ
LowBenchmark—100%
Pass