System Requirements Specification (SyRS) — ISO/IEC/IEEE 15289 — Specification | IEEE 29148 §6.2–6.4
Generated 2026-03-27 — UHT Journal / universalhex.org
| Standard | Title |
|---|---|
| IEC 60601 | — |
| IEC 60601-1-8 | Alarm systems — General requirements, tests, and guidance |
| IEC 62304 | Medical device software — Software life cycle processes |
| IEC 80001-1 | — |
| IEEE 11073 | — |
| IEEE 1588 | Standard for a Precision Clock Synchronization Protocol for Networked Measurement and Control Systems |
| IEEE 802.1Q | — |
| Acronym | Expansion |
|---|---|
| ARC | Architecture Decisions |
| CCCS | Completeness, Consistency, Correctness, Stability |
| EARS | Easy Approach to Requirements Syntax |
| IFC | Interface Requirements |
| STK | Stakeholder Requirements |
| SUB | Subsystem Requirements |
| SYS | System Requirements |
| UHT | Universal Hex Taxonomy |
| VER | Verification Plan |
| Ref | Requirement | V&V | Tags |
|---|---|---|---|
| STK-STAKEHOLDERNEEDS-001 | The Hospital Patient Monitoring System SHALL continuously monitor patient vital signs including heart rate, blood pressure, oxygen saturation, respiration rate, and body temperature without interruption during the patient's stay. | — | stakeholder, session-169 |
| STK-STAKEHOLDERNEEDS-002 | The Hospital Patient Monitoring System SHALL alert clinical staff within clinically acceptable timeframes when patient vital signs deviate from prescribed thresholds. | — | stakeholder, session-169 |
| STK-STAKEHOLDERNEEDS-003 | The Hospital Patient Monitoring System SHALL integrate with the hospital Electronic Health Record system to provide a unified patient data view and avoid duplicate data entry. | — | stakeholder, session-169 |
| STK-STAKEHOLDERNEEDS-004 | The Hospital Patient Monitoring System SHALL comply with applicable medical device regulations including IEC 60601, IEC 62304, and FDA 21 CFR Part 820 quality system requirements. | — | stakeholder, session-169 |
| STK-STAKEHOLDERNEEDS-005 | The Hospital Patient Monitoring System SHALL reduce clinically non-actionable alarms to mitigate alarm fatigue among nursing staff while maintaining sensitivity to genuine patient deterioration events. | — | stakeholder, session-169 |
| STK-STAKEHOLDERNEEDS-006 | The Hospital Patient Monitoring System SHALL protect patient health information in accordance with HIPAA privacy and security rules and hospital data governance policies. | — | stakeholder, session-169 |
| Ref | Requirement | V&V | Tags |
|---|---|---|---|
| SYS-SYSTEM-LEVELREQUIREMENTS-001 | The Hospital Patient Monitoring System SHALL acquire and display continuous ECG waveforms with a minimum of 3-lead configuration at a sampling rate of no less than 250 Hz. | — | system, vital-signs, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-002 | The Hospital Patient Monitoring System SHALL measure and display pulse oximetry (SpO2) with an accuracy of +/- 2% in the range of 70-100% saturation. | — | system, vital-signs, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-003 | The Hospital Patient Monitoring System SHALL perform non-invasive blood pressure measurements at configurable intervals ranging from 1 minute to 480 minutes and on manual demand. | — | system, vital-signs, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-004 | When a monitored vital sign exceeds a configured alarm threshold, the Hospital Patient Monitoring System SHALL generate an audible and visual alarm at the bedside within 10 seconds of threshold violation. | — | system, alarm, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-005 | The Hospital Patient Monitoring System SHALL display real-time vital signs and alarm status for all monitored patients on the central monitoring station simultaneously, supporting a minimum of 32 patients per station. | — | system, display, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-006 | The Hospital Patient Monitoring System SHALL export patient vital sign data and alarm events to the Electronic Health Record using HL7 FHIR R4 observation resources. | — | system, integration, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-007 | The Hospital Patient Monitoring System SHALL automatically associate bedside monitors with patient identity upon receiving ADT admit messages and disassociate upon discharge. | — | system, integration, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-008 | The Hospital Patient Monitoring System SHALL support configurable alarm delay periods of 0 to 60 seconds per parameter to suppress transient threshold crossings caused by patient movement or artifact. | — | system, alarm, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-009 | The Hospital Patient Monitoring System SHALL encrypt all patient data in transit using TLS 1.2 or higher and at rest using AES-256 encryption. | — | system, security, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-010 | The Hospital Patient Monitoring System SHALL maintain continuous monitoring operation during a single network path failure through redundant communication links with automatic failover completing within 5 seconds. | — | system, network, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-011 | The Hospital Patient Monitoring System SHALL store a minimum of 72 hours of trending data per patient including all monitored vital sign parameters at one-minute resolution. | — | system, storage, session-169 |
| SYS-SYSTEM-LEVELREQUIREMENTS-012 | The Hospital Patient Monitoring System SHALL meet the safety and essential performance requirements of IEC 60601-1-8 for medical electrical equipment alarm systems. | — | system, regulatory, session-169 |
| Source | Target | Type | Description |
|---|---|---|---|
| STK-STAKEHOLDERNEEDS-006 | SYS-SYSTEM-LEVELREQUIREMENTS-009 | derives | |
| STK-STAKEHOLDERNEEDS-005 | SYS-SYSTEM-LEVELREQUIREMENTS-008 | derives | |
| STK-STAKEHOLDERNEEDS-004 | SYS-SYSTEM-LEVELREQUIREMENTS-012 | derives | |
| STK-STAKEHOLDERNEEDS-003 | SYS-SYSTEM-LEVELREQUIREMENTS-011 | derives | |
| STK-STAKEHOLDERNEEDS-003 | SYS-SYSTEM-LEVELREQUIREMENTS-007 | derives | |
| STK-STAKEHOLDERNEEDS-003 | SYS-SYSTEM-LEVELREQUIREMENTS-006 | derives | |
| STK-STAKEHOLDERNEEDS-002 | SYS-SYSTEM-LEVELREQUIREMENTS-005 | derives | |
| STK-STAKEHOLDERNEEDS-002 | SYS-SYSTEM-LEVELREQUIREMENTS-004 | derives | |
| STK-STAKEHOLDERNEEDS-001 | SYS-SYSTEM-LEVELREQUIREMENTS-010 | derives | |
| STK-STAKEHOLDERNEEDS-001 | SYS-SYSTEM-LEVELREQUIREMENTS-003 | derives | |
| STK-STAKEHOLDERNEEDS-001 | SYS-SYSTEM-LEVELREQUIREMENTS-002 | derives | |
| STK-STAKEHOLDERNEEDS-001 | SYS-SYSTEM-LEVELREQUIREMENTS-001 | derives |