← All reports
PDF Excel ReqIF

Hospital Patient Monitoring System

Verification Plan (SVP) — ISO/IEC/IEEE 15289 — Plan | IEEE 29148 §6.6
Generated 2026-03-27 — UHT Journal / universalhex.org

19
Verification Entries
26
Verification Links
14
Orphans

Verification Requirements (VER)

RefRequirementMethodTags
VER-VERIFICATIONMETHODS-001 The threshold evaluation latency of the Alarm Detection Engine SHALL be verified by test, injecting vital sign samples at maximum acquisition rate and measuring the time from sample receipt to alarm condition event generation, confirming it does not exceed 500 milliseconds across 10000 consecutive samples. verification, alarm-management, session-171
VER-VERIFICATIONMETHODS-002 The IEC 60601-1-8 priority classification of the Alarm Prioritization Module SHALL be verified by inspection of the alarm priority mapping table and by test using a predefined set of alarm conditions covering all three priority levels, confirming correct classification for each. verification, alarm-management, session-171
VER-VERIFICATIONMETHODS-003 The crisis alarm bypass behaviour of the Alarm Fatigue Mitigation Unit SHALL be verified by test, configuring maximum delay and suppression settings and then injecting a crisis-priority alarm, confirming the alarm passes to the Notification Controller with zero delay. verification, alarm-management, session-171
VER-VERIFICATIONMETHODS-004 The tamper-evident audit trail of the Alarm History and Audit Logger SHALL be verified by test, generating a sequence of alarm events across all lifecycle states and confirming that every event is recorded with correct timestamp, patient identifier, and operator identity, and that any post-hoc modification is detectable. verification, alarm-management, session-171
VER-VERIFICATIONMETHODS-005 The automatic patient-monitor binding upon ADT Admit of the Patient ADT Manager SHALL be verified by integration test using a simulated HL7 ADT^A01 message sequence, measuring the time from message receipt to confirmed binding in the Clinical Data Repository, with pass criteria of binding completion within 2 seconds for 100 consecutive admit events. verification, clinical-data-integration, session-173
VER-VERIFICATIONMETHODS-006 The LOINC mapping completeness of the Terminology and Coding Service SHALL be verified by inspection of the terminology mapping table against the full set of vital sign measurement types produced by the Vital Signs Acquisition Subsystem, with pass criteria of a valid LOINC code assigned to at least 99% of standard measurement types. verification, clinical-data-integration, session-173
VER-VERIFICATIONMETHODS-007 The TLS encryption and mutual certificate authentication of the Data Export Controller interface SHALL be verified by penetration test capturing outbound traffic during clinical data export, confirming TLS 1.2 or higher negotiation and mutual certificate exchange, with pass criteria of zero plaintext observation data detected in captured traffic. verification, clinical-data-integration, session-173
VER-VERIFICATIONMETHODS-008 Verification of network switch latency SHALL be performed by injecting timestamped test frames at line rate across all active ports and measuring one-way delay using hardware timestamping, confirming 99th percentile latency remains below 500 microseconds. verification, network, session-174
VER-VERIFICATIONMETHODS-009 Verification of network failover SHALL be performed by physically disconnecting the primary uplink during active vital sign streaming and measuring the interval until data delivery resumes on the redundant path, confirming completion within 3 seconds with zero alarm message loss. verification, network, session-174
VER-VERIFICATIONMETHODS-010 Verification of wireless roaming handoff SHALL be performed by moving a mobile patient monitor through coverage overlap zones at walking speed while streaming continuous vital signs, confirming no data gap exceeds 100 milliseconds via packet capture analysis. verification, network, session-174
VER-VERIFICATIONMETHODS-011 The ECG signal bandwidth and sampling rate of the ECG Acquisition Module SHALL be verified by test, applying calibrated sine wave signals at 0.05 Hz, 40 Hz, and 150 Hz through a patient simulator and measuring the digitised output amplitude, confirming frequency response within +/- 3 dB across the specified bandwidth and sampling rate of at least 500 Hz. verification, vital-signs-acquisition, session-175
VER-VERIFICATIONMETHODS-012 The ECG signal bandwidth and sampling rate of the ECG Acquisition Module SHALL be verified by test, applying calibrated sine wave signals at 0.05 Hz, 40 Hz, and 150 Hz through a patient simulator and measuring the digitised output amplitude, confirming frequency response within plus or minus 3 dB across the specified bandwidth and sampling rate of at least 500 Hz. verification, vital-signs-acquisition, session-175
VER-VERIFICATIONMETHODS-013 The arterial oxygen saturation accuracy of the Pulse Oximetry Module SHALL be verified by test using a multi-wavelength pulse oximeter tester simulating SpO2 levels at 70%, 80%, 90%, 95%, and 100%, confirming readings within 2 percentage points of the reference value and pulse rate accuracy within 3 bpm across the physiological range of 30 to 240 bpm. verification, vital-signs-acquisition, session-175
VER-VERIFICATIONMETHODS-014 The NIBP measurement accuracy and cuff safety limits of the NIBP Measurement Module SHALL be verified by test using a calibrated pressure source and adult arm simulator, confirming systolic and diastolic accuracy within 5 mmHg for mean arterial pressures of 60 to 200 mmHg, and verifying that cuff pressure never exceeds 300 mmHg and automatic deflation engages within 120 seconds. verification, vital-signs-acquisition, session-175
VER-VERIFICATIONMETHODS-015 The mains interference rejection of the Signal Conditioning Unit SHALL be verified by test, superimposing 50 Hz and 60 Hz sinusoidal signals at 1 mV peak-to-peak on a calibrated ECG reference signal and measuring residual mains frequency content at the output, confirming attenuation of at least 40 dB for both frequencies across all sensor input channels. verification, vital-signs-acquisition, session-175
VER-VERIFICATIONMETHODS-016 The waveform rendering performance of the Display Rendering Engine SHALL be verified by test, streaming continuous ECG waveforms to the display while measuring frame update rate and numeric vital sign update latency, confirming the waveform refresh rate meets or exceeds 25 frames per second and numeric readout updates complete within 1 second of source data change. verification, central-monitoring-station, session-175
VER-VERIFICATIONMETHODS-017 The patient tile capacity and alarm-driven reordering of the Patient Tile Manager SHALL be verified by test, configuring 32 simultaneous patient streams and triggering alarm state transitions on selected patients, confirming all 32 tiles render correctly and that alarm-priority reordering completes within 2 seconds of alarm state change. verification, central-monitoring-station, session-175
VER-VERIFICATIONMETHODS-018 The trend analysis buffer retention and deterioration detection of the Trend Analysis Engine SHALL be verified by test, injecting 72 hours of simulated vital sign data with a programmed gradual deterioration pattern, confirming trend buffer retention of the full 72-hour window and detection of the deterioration trend within 15 minutes of onset by comparison against the embedded early warning scoring algorithm. verification, central-monitoring-station, session-175
VER-VERIFICATIONMETHODS-019 The multi-bed overview capacity of the Multi-bed Overview Processor SHALL be verified by test, simulating a full ward of 32 patients with concurrent vital sign streams, alarm conditions, and demographic data updates, confirming that the consolidated overview refreshes within 3 seconds and correctly reflects the alarm status, bed assignment, and latest vitals for every active patient. verification, central-monitoring-station, session-175

Traceability Matrix — Verification

RequirementVerified ByDescription
IFC-INTERFACEDEFINITIONS-014 VER-VERIFICATIONMETHODS-007
IFC-INTERFACEDEFINITIONS-005 VER-VERIFICATIONMETHODS-001
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-028 VER-VERIFICATIONMETHODS-019
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-027 VER-VERIFICATIONMETHODS-019
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-024 VER-VERIFICATIONMETHODS-018
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-023 VER-VERIFICATIONMETHODS-018
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-022 VER-VERIFICATIONMETHODS-017
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-021 VER-VERIFICATIONMETHODS-017
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-020 VER-VERIFICATIONMETHODS-016
SUB-CENTRALMONITORINGSTATIONREQUIREMENTS-019 VER-VERIFICATIONMETHODS-016
SUB-SUBSYSTEMREQUIREMENTS-007 VER-VERIFICATIONMETHODS-015
SUB-SUBSYSTEMREQUIREMENTS-006 VER-VERIFICATIONMETHODS-014
SUB-SUBSYSTEMREQUIREMENTS-005 VER-VERIFICATIONMETHODS-014
SUB-SUBSYSTEMREQUIREMENTS-004 VER-VERIFICATIONMETHODS-013
SUB-SUBSYSTEMREQUIREMENTS-003 VER-VERIFICATIONMETHODS-013
SUB-SUBSYSTEMREQUIREMENTS-002 VER-VERIFICATIONMETHODS-012
SUB-SUBSYSTEMREQUIREMENTS-001 VER-VERIFICATIONMETHODS-012
SUB-SUBSYSTEMREQUIREMENTS-039 VER-VERIFICATIONMETHODS-010
SUB-SUBSYSTEMREQUIREMENTS-038 VER-VERIFICATIONMETHODS-009
SUB-SUBSYSTEMREQUIREMENTS-037 VER-VERIFICATIONMETHODS-008
SUB-SUBSYSTEMREQUIREMENTS-036 VER-VERIFICATIONMETHODS-006
SUB-SUBSYSTEMREQUIREMENTS-031 VER-VERIFICATIONMETHODS-005
SUB-SUBSYSTEMREQUIREMENTS-018 VER-VERIFICATIONMETHODS-004
SUB-SUBSYSTEMREQUIREMENTS-014 VER-VERIFICATIONMETHODS-003
SUB-SUBSYSTEMREQUIREMENTS-011 VER-VERIFICATIONMETHODS-002
SUB-SUBSYSTEMREQUIREMENTS-009 VER-VERIFICATIONMETHODS-001

Orphan Requirements (no trace links)

RefDocumentRequirement
SUB-SUBSYSTEMREQUIREMENTS-012 subsystem-requirements When a patient record indicates a known pre-existing condition for a monitored parameter, the Alarm Prioritization Modul...
SUB-SUBSYSTEMREQUIREMENTS-016 subsystem-requirements The Alarm Notification Controller SHALL transmit crisis and warning alarms to the nurse call system and designated mobil...
SUB-SUBSYSTEMREQUIREMENTS-017 subsystem-requirements When a crisis alarm remains unacknowledged for a configurable escalation period (default 120 seconds), the Alarm Notific...
SUB-SUBSYSTEMREQUIREMENTS-019 subsystem-requirements The Display Rendering Engine SHALL render continuous ECG waveforms at a minimum refresh rate of 25 frames per second wit...
SUB-SUBSYSTEMREQUIREMENTS-020 subsystem-requirements The Display Rendering Engine SHALL update numeric vital sign readouts within 1 second of receiving new parameter values ...
SUB-SUBSYSTEMREQUIREMENTS-021 subsystem-requirements The Patient Tile Manager SHALL support simultaneous display of at least 32 patient tiles, each showing the active vital ...
SUB-SUBSYSTEMREQUIREMENTS-022 subsystem-requirements When a patient alarm state changes, the Patient Tile Manager SHALL reorder the tile display within 2 seconds so that pat...
SUB-SUBSYSTEMREQUIREMENTS-023 subsystem-requirements The Trend Analysis Engine SHALL maintain rolling trend buffers of at least 72 hours duration for each monitored vital si...
SUB-SUBSYSTEMREQUIREMENTS-024 subsystem-requirements The Trend Analysis Engine SHALL detect gradual vital sign deterioration by computing a weighted early warning score at 5...
SUB-SUBSYSTEMREQUIREMENTS-025 subsystem-requirements The Alert Dashboard Controller SHALL provide a one-touch alarm acknowledgement control that records the acknowledging cl...
SUB-SUBSYSTEMREQUIREMENTS-026 subsystem-requirements When a clinician activates the alarm silence function, the Alert Dashboard Controller SHALL suppress the audible annunci...
SUB-SUBSYSTEMREQUIREMENTS-027 subsystem-requirements The Multi-bed Overview Processor SHALL generate a ward-level acuity summary screen that colour-codes each bed by the hig...
SUB-SUBSYSTEMREQUIREMENTS-028 subsystem-requirements The Multi-bed Overview Processor SHALL compute and display per-bed alarm frequency statistics over configurable time win...
VER-VERIFICATIONMETHODS-011 verification-plan The ECG signal bandwidth and sampling rate of the ECG Acquisition Module SHALL be verified by test, applying calibrated ...