Metrological Testing (MT) of Medical Technology

Calibrating and Verifying Your Medical Equipment

Whether it’s radiation thermometers, blood pressure monitors, or audiometers – are you sure your medical devices perform within the range of acceptable errors in measurement? Our experts can run quality and safety tests on your medical equipment - and document its reliability in the legal record for medical devices. The tested devices are all marked with individual bar codes.

Benefits at a Glance

Let TÜV Rheinland measure the reliability of your medical equipment to:

  • Ensure precise diagnostics, technical quality, and the safety of both patients and device operators
  • Gain legal security by fulfilling your requirements as an operator of medical devices
  • Never miss another inspection
  • Save money - because our testing agents are not there to try and sell costly repairs
  • Find out exactly what needs repairing - and demand exactly that
  • Benefit from our neutrality in testing and from our years of experience
  • Get an individual safety package with additional testing services
  • Receive one-stop service - because we collaborate with the Bureau of Standards and with testing laboratories accredited by TÜV Rheinland
  • Draw on the support of the nation's leading service provider in medical technology
  • Save time on your technical paperwork - because we import the test data into your device management software

Our Metrological Testing (MT) Services for Medical Equipment

Our experts run on-site inspections of your equipment. The tests follow standard and manufacturer-specific guidelines. We are responsible for:

  • Visual inspection, quality and performance testing, and determining compliance with limits on measurement error.
  • Marking tested devices with individual bar codes.
  • Final evaluation and discussion, including information on safety-related defects.
  • Documenting the results with test reports and statistics.
  • Providing advice on liability issues that may arise from various regulations on medical devices.
  • Importing test data into device management software - and comparing it to master data.

Legal Standards for Our Services

  • Law on medical devices (Medizinproduktegesetz, MPG)
  • Regulation on medical device operators (Medizinprodukte-Betreiberverordnung, MPBetreibV)
  • MPBetreibV Appendix 2 (in connection with MPBetreibV § 11)
  • Guide for metrological testing of medical measurement devices (Leitfaden zu messtechnischen Kontrollen von Medizinprodukten mit Messfunktion, LMKM)

Examples of Devices We Test

  • Blood pressure monitors
  • Temperature gauges
  • Infrared radiation thermometers
  • Temperature sensors
  • Tone and speech audiometers
  • Foot ergometers
  • X-ray equipment