Testing of medical devices in accordance with applicable standards (STK / MTK)Regular safety inspections (STK) and metrological inspections (MTK) are essential to ensure the functionality and electrical safety of medical devices. They provide reliable protection for patients and users.
Medical devices are a central part of modern patient care. The German Medical Devices Operator Ordinance (MPBetreibV) therefore requires regular testing to ensure operational safety and measurement accuracy.
Modern test instruments from Gossen Metrawatt and Rigel enable fast, reliable STK and MTK inspections in accordance with applicable standards.
The instruments are specifically designed to ensure the electrical safety and functionality of a wide range of medical devices and to integrate test results efficiently into test reports.
Modern test instruments for STK and MTK inspections in accordance with applicable standardsIntuitive touchscreen navigation, automated test sequences and customisable test reports make everyday work easier.
Precise testing ensures compliance with relevant standards such as IEC 60601, IEC 62353 and ISO 13485.
A compact, lightweight design and battery operation enable flexible use on the go.
Quick tests and preprogrammed test sequences speed up the entire testing process.
SECULIFE ST PRO from GMC InstrumentsThe SECULIFE ST PRO from GMC Instruments was specifically developed for biomedical technicians and service teams with the highest requirements for safety, precision and efficiency.
Its antimicrobial surface supports hygiene in sensitive medical environments, while integrated UDI management enables comprehensive documentation.
PatSim 200 and PatSim 400 – realistic patient simulationThe PatSim 200 and PatSim 400 patient simulators from Rigel Medical combine intuitive operation, comprehensive testing capabilities and a compact design.
| Standard / Regulation | Description |
|---|---|
| IEC 60601 | Safety and performance of medical electrical equipment |
| IEC 62353 | Recurrent testing of medical electrical equipment |
| ISO 14971 | Risk management for medical devices |
| VDE 0751 | Testing of medical electrical equipment after repair |
| MDR (EU) 2017/745 | Safety requirements for medical devices in the EU |