NCCE flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

IEC 60601-1

General standard for basic safety and essential performance of medical electrical equipment; collateral and particular standards add device-specific requirements for testing and compliance.

Essential performance

Performance of a medical device necessary to maintain residual risk within acceptable limits; loss or degradation must be evaluated during testing and risk analysis.

Type CF applied part

Applied part with the highest degree of protection against electric shock, suitable for direct cardiac contact; patient leakage current limited to 10 µA in normal condition.

Microshock

Low-level current passing through a low-resistance pathway such as an intracardiac catheter; currents as low as 10 µA can induce ventricular fibrillation.

Line isolation monitor

Device monitoring an isolated power system in critical care areas; alarms when hazard current exceeds 5 mA, allowing one fault to ground without power interruption.

Ground continuity test

Verification that resistance between the protective earth pin and exposed conductive parts is typically ≤ 0.1 Ω using a test current of at least 25 A.

Leakage current limits

IEC 60601-1 normal-condition limits: earth leakage ≤ 5 mA, patient leakage type BF ≤ 100 µA, type CF ≤ 10 µA; single-fault limits are higher.

Risk management ISO 14971

Standard process for identifying hazards, estimating and evaluating risk, implementing controls, and monitoring residual risk throughout the device lifecycle.

Recall Class I

Recall classification for a device with reasonable probability of serious adverse health consequences or death; requires immediate action and public notification.

Uptime formula

Uptime = (scheduled available time − downtime) / scheduled available time × 100; downtime includes response, repair, and parts wait time.

Incoming inspection

Verification of a new device against the purchase order, including safety testing, performance verification, and documentation before clinical release.

Risk-based PM interval

Preventive maintenance schedule derived from manufacturer recommendations, device criticality, failure history, and clinical use, with documented justification for deviations.

CMMS

Computerized maintenance management system used to track work orders, equipment inventory, PM schedules, calibration records, and maintenance history for regulatory compliance.

Pulse oximetry principle

Ratio-of-ratios of red (660 nm) and infrared (940 nm) absorbance; accuracy is degraded by carboxyhemoglobin, methemoglobin, motion, and poor perfusion.

Defibrillator energy verification

Delivered energy is measured with a calibrated analyzer; biphasic waveforms typically use 120–200 J versus 360 J monophasic, verified annually and after repair.

Electrosurgical unit waveforms

Monopolar coagulation uses interrupted high-voltage bursts; cut uses continuous low-voltage waveform; dispersive electrode contact controls current density and burn risk.

Infusion pump accuracy

Flow accuracy verified gravimetrically, typically ±5% for volumetric pumps at mid-rate; occlusion alarm thresholds checked against manufacturer specification.

CT dose metrics

CTDIvol and DLP (mGy·cm) quantify CT radiation dose; DLP × k-factor estimates effective dose; HVL and kVp accuracy tests verify exposure.

Alarm priority IEC 60601-1-8

High-priority alarms require visual and auditory signals distinguishable at 1 m; signal characteristics must match the physiological alarm condition.

Calibration traceability

Test instruments must be traceable to national standards such as NIST, with documented calibration certificates and defined calibration intervals.

Electrical safety test sequence

Visual inspection → ground continuity → insulation resistance → leakage current (earth, enclosure, patient) → functional performance verification.

Battery capacity testing

Lithium-ion batteries degrade with age and cycle count; periodic capacity testing and replacement schedules prevent device failure during clinical use.

HL7 and FHIR

Standards for exchanging clinical data; HL7 v2 messages and FHIR resources carry device observations and patient data between devices and EHR systems.

Medical device VLAN

Network segmentation isolating clinical devices from enterprise IT; firewalls and access control lists limit lateral movement and protect patient data.

NTP time synchronization

Network time protocol keeps device and EHR clocks aligned; clock drift causes misattributed alarms and documentation errors in the clinical record.

SBOM

Software bill of materials listing components and dependencies of device software; used for vulnerability monitoring and cybersecurity risk management.

NFPA 99

Healthcare facilities code covering electrical systems, medical gas, and utilities; defines essential electrical system branches and critical care requirements.

Medical gas zone valve

Shutoff valve for a section of the medical gas pipeline; pressure and purity are verified per NFPA 99 and USP standards, with alarms for abnormal conditions.

Operating room HVAC

Operating rooms require positive pressure relative to adjacent spaces and typically 20–25 air changes per hour with HEPA filtration; isolation rooms use negative pressure.

Legionella control

Water management with hot water storage ≥ 60 °C and return ≥ 51 °C, plus flushing protocols, to prevent Legionella growth in facility plumbing.

Clinical engineering ethics

Prioritize patient safety over cost or convenience; disclose conflicts of interest and report unsafe conditions through proper channels.

Adverse event reporting

US manufacturers report deaths and serious injuries to FDA within 30 days (5 days for certain events); user facilities report deaths to FDA and the manufacturer.