The Comprehensive Challenges of Medical Device Testing

Medical devices encompass a wide range of equipment, including the commonly seen electrical medical devices. These electrical devices, frequently found in hospitals, must undergo rigorous functional (Performance Test) and electrical safety tests (Safety Test). Electrical safety testing includes legally required tests such as Ground Bond testing, Hipot/Withstanding/Dielectric Strength testing, Insulation Resistance Measurement, and Leakage Current testing.

High-performance medical technologies and equipment are designed for disease treatment and diagnosis. Especially in these applications, clear and accurate measurements and results are crucial for each patient. Untested medical equipment failures can lead to severe consequences.

Ensuring the performance, safety, and functionality of medical devices is paramount. Testing intervals are typically specified by the medical device or system manufacturer. In any case, the operator of the technical equipment must ensure that appropriate tests are performed at the proper intervals.

Gossen Metrawatt GmbH (GMC-I) is a measurement instrument manufacturer with over a century of history, offering a variety of testing instruments required for medical devices and is favored by major European and American manufacturers.

VASTi Technologies exclusively provides all GMC-I medical device testing instruments. Whether you are a healthcare facility, medical device manufacturer, or medical device distributor, we can provide consistent instrument sales and service.

Solutions

Safety Technical Control (STC)

The purpose of this inspection is to prevent accidents involving patients, users, or third parties by identifying and correcting defects early on. This approach reduces the risks associated with medical device malfunctions.

Medical devices requiring safety inspections include:

Patient monitors – invasive
Incubators
Ultrasound devices
Defibrillators
HF surgery devices
Infusion pumps
Syringe pumps
External pacemakers
Ultrasound therapy devices
ECG devices
The safety inspection begins with a visual inspection. While seemingly superficial, this involves a thorough examination of numerous components and parts. Another crucial aspect is verifying all warning devices and alarms. The inspector is obligated to prepare an inspection report containing all safety check measurements and results. Only qualified personnel are authorized to test medical devices and products.

 

Metrological Control (, MC)

In addition to safety inspections, metrological verification is often a legal requirement for medical devices. Quantities requiring measurement include pressure, dosage, temperature, and flow rate. Medical technology products with measuring functions must be verified, such as:

Medical electronic thermometers
Blood pressure monitors
Tonometers
Therapeutic dosimeters
Diagnostic dosimeters
Metrological inspections may involve comparative measurement methods or utilize metrological standards as a basis. These standards may incorporate very small error limits and measurement uncertainties.

 

Electraical Safety Test

Electrical equipment in healthcare facilities often causes electrical injury accidents due to improper use or electrical leakage. Electrical safety testing (e.g., IEC 62353) must be performed on equipment before calibration, after maintenance, or after inspection. Regular periodic testing is also necessary. These checks are intended to ensure the safety of patients, staff, or third parties.

Visual Inspection – Check the electrical equipment for externally visible defects and damage, and verify the presence of safety-related labels and correct markings.

Electrical Measurement – Record various electrical measurement changes according to the equipment type, protection class, and measurement procedures.

Functional Test – This can only be performed after a successful visual inspection and electrical measurements showing no faults; the equipment is tested according to its operating conditions.

After testing is complete and no defects are found, the medical device will be labeled, for example, with a corresponding test tag.