Execute systematic electrical safety testing ensuring IEC 60601 compliance and patient protection.
Standard | Title | Applicable Sections |
---|---|---|
IEC 60601-1 | General requirements for basic safety and essential performance | All applicable clauses |
IEC 60601-1-2 | Electromagnetic disturbances - Requirements and tests | All applicable clauses |
IEC 60601-2-25 | Particular requirements for electrocardiographs | Device-specific requirements |
IEC 62304 | Medical device software lifecycle processes | Software safety classification |
Test | Requirement | Test Voltage | Acceptance Criteria |
---|---|---|---|
Basic Insulation | IEC 60601-1 Clause 8.8.3 | 500V DC | ≥2 MΩ |
Reinforced Insulation | IEC 60601-1 Clause 8.8.3 | 500V DC | ≥4 MΩ |
Applied Parts Insulation | IEC 60601-1 Clause 8.8.3 | 500V DC | ≥10 MΩ |
Test | Test Voltage | Duration | Acceptance Criteria |
---|---|---|---|
Basic Insulation | 1500V AC | 60 seconds | No breakdown or flashover |
Reinforced Insulation | 3000V AC | 60 seconds | No breakdown or flashover |
Applied Parts | 1500V AC | 60 seconds | No breakdown or flashover |
Leakage Current Type | Normal Condition | Single Fault Condition | Acceptance Criteria |
---|---|---|---|
Earth Leakage | <500 μA | <1000 μA | IEC 60601-1 Table 3 |
Enclosure Leakage | <100 μA | <500 μA | IEC 60601-1 Table 3 |
Patient Leakage (Type BF) | <100 μA | <500 μA | IEC 60601-1 Table 3 |
Test | Standard | Frequency Range | Acceptance Criteria |
---|---|---|---|
Radiated Emissions | CISPR 11 | 30 MHz - 1 GHz | Group 1 Class B limits |
Conducted Emissions | CISPR 11 | 150 kHz - 30 MHz | Group 1 Class B limits |
Test | Standard | Test Level | Acceptance Criteria |
---|---|---|---|
Electrostatic Discharge | IEC 61000-4-2 | ±8 kV contact, ±15 kV air | Criterion B: Temporary degradation acceptable |
Radiated Immunity | IEC 61000-4-3 | 10 V/m, 80-2700 MHz | Criterion A: Normal operation maintained |
Electrical Fast Transients | IEC 61000-4-4 | ±2 kV power, ±1 kV signal | Criterion B: Temporary degradation acceptable |
Parameter | Requirement | Test Method | Acceptance Criteria |
---|---|---|---|
Amplitude Accuracy | ±5% or ±50 μV | Calibrated signal generator | Within specified tolerance |
Frequency Response | 0.05-150 Hz (±3 dB) | Swept frequency testing | Meet frequency response curve |
Common Mode Rejection | >80 dB | Common mode signal injection | >80 dB rejection ratio |
Test | Requirement | Test Method | Acceptance Criteria |
---|---|---|---|
Operating Time | ≥24 hours continuous | Continuous operation test | Meet specified duration |
Charging Safety | No overcharge hazard | Charge cycle testing | Safe charging behavior |
Low Battery Warning | Warning at 10% capacity | Battery discharge test | Timely warning provided |
What electrical safety standards apply to my medical device?
How do I determine the applied parts classification for my device?
What is the difference between basic, supplementary, and reinforced insulation?
How should I handle EMC testing for wireless medical devices?
What should I do if my device fails electrical safety testing?
How do I verify essential performance during electrical testing?