Metrological Testing (MTK)

Testing the measurement accuracy of medical devices in accordance with §15 MPBetreibV

What is the MTK?

The Metrological Testing (MTK) in accordance with §15 MPBetreibV verifies the measurement accuracy of medical devices with measuring functions (Annex 2 MPBetreibV). Incorrect measurements can lead to wrong diagnoses and treatment decisions – the MTK ensures that your devices measure reliably.

Which devices require MTK?

All medical devices listed in Annex 2 MPBetreibV with measuring functions:

  • Non-invasive blood pressure monitors
  • Electronic clinical thermometers (infrared, electronic)
  • Audiometers
  • Tympanometers
  • Ergometers (bicycle and treadmill ergometers)
  • Tonometers
  • Pulse oximeters (with measurement display)

What is tested during the MTK?

  • Measurement accuracy across the entire measurement range against DAkkS-calibrated reference standards
  • Repeatability – testing the reproducibility of measurement results
  • Display accuracy – deviation of the displayed value from the reference value
  • Visual inspection for mechanical damage and condition
  • Functional testing of all display and control elements
  • Documentation with test report and inspection label

Our Test Equipment

For the MTK, we exclusively use DAkkS-calibrated reference test equipment traceable to national standards (§15 para. 4 MPBetreibV):

  • Calibrated reference manometers for blood pressure monitors
  • Reference thermometers with measurement uncertainty ≤ ±0.03°C
  • Calibrated audiometer test equipment
  • Annual recalibration of all reference standards

MTK Intervals

  • Non-invasive blood pressure monitors – 2 years
  • Electronic clinical thermometers – 2 years
  • Audiometers – 1 year
  • Tympanometers – 1 year
  • Ergometers – 2 years
  • Tonometers – 2 years

Why Medizintechnik Driller for Your MTK?

  • DAkkS-calibrated reference test equipment with proven traceability
  • Testing in accordance with PTB guideline LMKM
  • Proper authority notification in accordance with §15 para. 8 MPBetreibV
  • On-site testing – minimal downtime for your devices
  • Combination with STK and DGUV V3 for maximum efficiency

Legal Notice

The MTK is legally required (§15 MPBetreibV). Operators must have MTK-required devices tested on time. Test equipment must be traceable to national standards. Alexander Driller has the required metrological qualification, DAkkS-calibrated test equipment and the authority notification in accordance with §15 para. 8 MPBetreibV.