| Occlusion Detection | Detects downstream resistance and provides an audible and visual alarm. | Confirm adjustable or clinically appropriate occlusion thresholds, alarm visibility, alarm volume, and alarm response time. Check whether the pump documents the occlusion pressure or event. | IEC 60601-2-24; risk management under ISO 14971. | Critical |
| Air-in-Line Protection | Detects air in the syringe or delivery line where the device design supports this function. | Verify the detection method, alarm behavior, minimum detectable air volume specified by the manufacturer, and compatibility with the intended syringe and tubing configuration. | IEC 60601-2-24; clinical risk assessment. | Critical |
| Free-Flow Prevention | Prevents unintended gravity flow when the syringe is not correctly secured or when the drive mechanism is released. | Test the syringe clamp, plunger-retainer mechanism, loading sequence, door or latch interlock, and behavior during power loss or accidental release. | IEC 60601-2-24; manufacturer instructions for use. | Critical |
| Anti-Bolus Performance | Limits unintended post-occlusion bolus delivery when pressure is released. | Review post-occlusion bolus data, automatic pressure reduction features, restart behavior, and suitability for low-flow or high-risk infusions. | IEC 60601-2-24; risk-based clinical evaluation. | High |
| Dose-Rate Accuracy | Maintains the programmed delivery rate within the declared accuracy limits. | Compare the stated accuracy across the intended flow-rate range, syringe sizes, start-up period, battery operation, and back-pressure conditions. | IEC 60601-2-24; verify against the manufacturer’s published specification. | High |
| Alarm System | Provides distinct alarms for occlusion, near-empty syringe, end of infusion, low battery, door or clamp problems, and system faults. | Check alarm priority, visual indicators, audible volume, alarm silence duration, event logging, and whether alarms remain understandable in a noisy clinical environment. | IEC 60601-1-8; IEC 60601-2-24; usability engineering under IEC 62366-1. | Critical |
| Syringe Compatibility | Correctly identifies or securely accommodates approved syringe sizes and geometries. | Review the approved syringe list, recognition method, clamp fit, plunger engagement, barrel alignment, and consequences of using an unapproved syringe. | Manufacturer instructions for use; IEC 60601-2-24 performance verification. | Critical |
| Power and Battery Safety | Continues safely during power interruption and provides an early low-battery warning. | Check battery type, expected runtime under clinical load, charging time, battery replacement procedure, power-fail alarm, and behavior when switching between mains and battery power. | IEC 60601-1; manufacturer battery specifications and preventive-maintenance procedures. | High |
| User Interface and Lockout | Reduces programming errors through clear displays, guarded controls, and configurable key or rate lockout. | Assess unit selection, decimal-point visibility, confirmation prompts, language options, screen readability, keypad lock, and protection against accidental rate changes. | IEC 62366-1; IEC 60601-1-8; local medication-safety policy. | High |
| Drug Library and Dose Limits | Supports standardized drug profiles, concentration limits, dose limits, and optional hard or soft alerts. | Confirm governance for library creation, approval, version control, update access, audit trails, and override documentation. Do not treat a drug library as a substitute for clinical verification. | IEC 62304 for applicable software lifecycle processes; IEC 62366-1; institutional medication policy. | High |
| Electrical and EMC Safety | Provides protection against electric shock, leakage current, overheating, and electromagnetic interference. | Request the applicable conformity documentation, inspect power cords and connectors, and verify suitability for the intended clinical environment and adjacent equipment. | IEC 60601-1; IEC 60601-1-2; applicable regulatory requirements. | Critical |
| Cleaning and Infection Control | Surfaces and accessories tolerate approved cleaning and disinfection procedures without damage. | Check the validated disinfectants, contact time, wipe or immersion restrictions, ingress protection, crevices, detachable parts, and procedures for fluid contamination. | Manufacturer cleaning instructions; facility infection-prevention policy. | High |
| Preventive Maintenance | Uses a documented, risk-based program rather than relying only on a calendar date. | Confirm service intervals in the instructions for use, maintenance tasks, responsible personnel, required tools, pass/fail criteria, and conditions that require immediate removal from service. | Manufacturer service manual; ISO 14971 risk management; facility medical-equipment policy. | High |
| Calibration and Functional Testing | Verifies flow accuracy, alarm operation, occlusion response, battery condition, and mechanical performance. | Use calibrated test equipment with traceable records. Document test conditions, syringe size, programmed rate, measured output, alarm results, tolerance limits, technician, and date. | IEC 60601-2-24; manufacturer test procedure; ISO/IEC 17025 principles for measurement traceability. | Critical |
| Service Records and Traceability | Maintains a complete history of inspection, repair, software changes, calibration, and incidents. | Check for unique equipment identification, service dates, results, corrective actions, parts used, software version, next-due date, and release-to-use authorization. | ISO 13485 quality-system principles; facility asset-management policy. | High |
| Training and Competency | Ensures operators can load syringes correctly, program doses, respond to alarms, and identify unsafe conditions. | Require documented initial and refresher training, competency assessment, quick-reference instructions, and a defined escalation process for device faults. | IEC 62366-1 usability principles; local clinical training requirements. | High |
| Software and Cybersecurity Controls | Protects configuration, drug-library updates, user access, logs, and network-connected functions where applicable. | Review access control, update authorization, backup and recovery, audit logs, vulnerability notification, unsupported software status, and secure decommissioning procedures. | IEC 62304 for applicable software lifecycle processes; IEC 81001-5-1 where applicable; organizational cybersecurity policy. | High |