How its tested matters - Your trusted partner
How its tested matters - Your trusted partner
At TÜV SÜD, we combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing a one-stop solution. Our testing regimen subjects your product to a comprehensive evaluation in line with the rigorous standards of the medical devices industry, which serves as a testament to your product's compliance with global standards and regulations.
Our testing suite spans the entirety of your design and production cycle - from prototype testing to CB certification and lab tests for ergonomic, electrical, mechanical, and functional safety assessments, as well as software testing, to ensure a holistic review of your medical devices.
Up to 40Ghz frequency range within 10m Semi-Anechoic chamber
10Khz - 108Mhz. Three Phase up to 200A
up to 32A
up to 32A
± 30KV. Both Commercial & Automotive
20Mhz – 6.0Ghz up to 100V/m
Three Phase up to ± 5.0KV
Three Phase up to ± 7.0KV
Three Phase up to ± 7.0KV
From 10Khz – 230Mhz up to 30Vrms
From 10Khz – 400Mhz up to 400mA
up to 300A/m (Continuous); 1000A/m (Short Time)
up to 1000A/m
Three Phase up to 32A
Transient Emission, Pulses (1, 2a, 2b,3a, 3b & 4), DC 80V/50A
In process*
General requirements for basic safety and essential performance of Medical electrical equipment
General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Requirements for the basic safety and essential performance of cardiac defibrillators
Requirements for the basic safety and essential performance of critical care ventilators
Requirements for the safety and essential performance of anesthetic systems
Requirements for the basic safety and essential performance of electrocardiographs
Requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Requirements for the Safety, Essential Performance of Automatic Cycling Non-Invasive BP Monitoring Equipment
Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
Requirements for the basic safety and essential performance of multifunction patient monitoring equipment
Requirements for basic safety and essential performance of pulse oximeter equipment
Safety requirements for electrical equipment for measurement, control, and laboratory use
Requirements for in vitro diagnostic (IVD) medical equipment
General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances. Requirements and tests
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Click here to know more about Non-Active Medical Devices
Test reports and certificates from TÜV SÜD laboratories are traceable, recognized, and accepted globally
TÜV SÜD’s test laboratories provide compliance testing, verification, validation, engineering, and re-engineering activities of Medical Devices
TÜV SÜD’s 10m Semi-Anechoic chamber is designed and constructed to accommodate testing of complex medical products such as CT, MRI, X-ray equipment
Our market access teams keep a constant watch on the change in global regulations, standards, and requirements and update the medical product fraternity on possible impact on their products and product families
Medical manufacturers can include a wide range of medical products under a single report and certificate, which helps to streamline regulatory processes for a seamless market entry
