Medical devices are instruments, equipment, systems or software used to diagnose, monitor, treat or alleviate diseases. Their electrical and functional safety is crucial to protecting patients and users. Regular testing ensures that the devices comply with legal requirements and applicable standards.
Testing in accordance with DGUV Regulation 3 verifies the electrical safety of portable and fixed electrical equipment. Its purpose is to prevent hazards caused by electrical faults and ensure safe operation in the workplace.
In healthcare facilities, it primarily applies to electrical equipment that is not classified as a medical device.
Metrological inspection (MTK) ensures that medical devices with a measuring function continue to operate within the permissible measurement tolerances. It is legally required for certain medical devices and ensures accurate and reliable measurement results, for example from blood pressure monitors or weighing scales.
Safety inspection (STK) verifies whether a medical device can continue to be operated safely. Safety-related functions and the technical condition of the device are assessed to rule out risks to patients, users and third parties.
Whether an STK is required and at what intervals depends on the manufacturer's instructions and applicable legal requirements.
Testing medical devices safely and in accordance with applicable standards| Characteristic | Safety Inspection (STK) | Metrological Inspection (MTK) |
|---|---|---|
| Key Question | Is the device safe to operate? | Does the device still measure accurately? |
| Scope of Inspection | Safety-related functions and technical condition | Measurement accuracy and permissible deviations |
| Examples | Defibrillators, ventilators, monitors | Blood pressure monitors, medical weighing scales |
How the elements of risk management work together in hospitals (AI-generated image)
| Medical Device | Testing in Accordance with IEC 62353 (Electrical Safety) |
Additional Functional Testing | STK / MTK | Relevant Standards |
|---|---|---|---|---|
| Electrosurgical Unit (HF Generator) | Visual inspection, protective earth, insulation / alternative leakage current, equipment and patient leakage current | HF power, REM system, output power, alarms | STK | IEC 62353 IEC 60601-2-2 IEC 60601-1 |
| Defibrillator | Protective earth, leakage currents, patient leakage currents | Defibrillation energy, charging time, synchronisation, ECG, battery | STK | IEC 62353 IEC 60601-2-4 IEC 60601-1 |
| Infusion / Syringe Pumps | Electrical safety testing | Delivery accuracy, flow rate, occlusion alarm, air bubble detection | STK | IEC 62353 IEC 60601-2-24 IEC 60601-1 |
| Patient Monitor | Electrical safety testing, including patient leakage current | ECG, SpO₂, NIBP, temperature, alarms, display | STK | IEC 62353 IEC 60601-1 IEC 60601-2-27 IEC 60601-2-30 IEC 60601-2-34 IEC 60601-2-49 IEC 60601-2-61 |
| Therapeutic Ultrasound Device | Electrical safety testing | Ultrasound power, frequency, timer | STK | IEC 62353 IEC 60601-2-5 IEC 60601-1 |
| Diagnostic Ultrasound System | Electrical safety testing | Image quality, Doppler, transducer testing | STK | IEC 62353 IEC 60601-2-37 IEC 60601-1 |
| TEE Probe | Electrical safety testing | Leak testing, articulation function, temperature monitoring, image quality | Depends on the manufacturer | IEC 62353 IEC 60601-2-37 IEC 60601-1 |
| Diagnostic Display | Electrical safety testing | DICOM calibration, brightness, uniformity, contrast | Depends on the manufacturer | IEC 62353 IEC 60601-1 DIN 6868-157 IEC 62563-1 |
| Medical Display (Within the Patient Environment) | Electrical safety testing | Display, touchscreen, alarm display | Depends on the manufacturer | IEC 62353 IEC 60601-1 |
| Anaesthesia Machine | Protective earth, leakage currents, patient leakage current | Leak testing, ventilation function, O₂ measurement, gas delivery, alarms, AGSS system | STK | IEC 62353 IEC 60601-2-13 IEC 60601-1 |
| Ventilator (Intensive Care / Emergency) | Electrical safety testing | Tidal volume, respiratory rate, pressure, flow, PEEP, alarm functions, oxygen measurement | STK | IEC 62353 IEC 60601-2-12 IEC 60601-2-84 IEC 60601-1 |
| Dialysis Machine | Electrical safety testing, including patient leakage current | Conductivity, temperature, ultrafiltration, blood leak detection, pressure sensors, alarms | STK | IEC 62353 IEC 60601-2-16 IEC 60601-1 |
| Stationary X-ray System | Electrical safety testing | Tube voltage (kV), tube current (mA), exposure time, dose, image quality | Acceptance and constancy testing | IEC 62353 IEC 60601-2-54 IEC 60601-1 DIN 6868 series |
| Mobile X-ray System / C-arm | Electrical safety testing | Generator output, image quality, radiation protection functions | STK / QA | IEC 62353 IEC 60601-2-54 IEC 60601-1 |
| Mammography System | Electrical safety testing | Image quality, dose, compression, generator parameters | Constancy testing | IEC 62353 IEC 60601-2-45 IEC 60601-1 |
| Computed Tomography (CT) Scanner | Electrical safety testing | Dose parameters, image quality, table movement, collimation | QA in accordance with national requirements | IEC 62353 IEC 60601-2-44 IEC 60601-1 |
| Magnetic Resonance Imaging (MRI) Scanner | Electrical safety testing of peripheral equipment | Gradient system, RF system, patient monitoring, cooling | QA in accordance with the manufacturer's requirements | IEC 62353 IEC 60601-2-33 IEC 60601-1 |
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