Question
Is it required for an LXcan or LXplus luminance meter to undergo a metrological inspection (MTK) according to §14 of the Medical Devices Operator Ordinance (MPBetreibV)?
Answer
No, it is not necessary for an LXcan or LXplus luminance meter to undergo a metrological inspection (MTK) according to §14 of the Medical Devices Operator Ordinance (MPBetreibV). This regulation applies only to specific devices listed in Appendix 2 of the MPBetreibV.
The MPBetreibV requires operators of medical devices to conduct or have conducted a metrological inspection on the devices listed in Appendix 2. This ensures the safety and accuracy of those devices are regularly checked to maintain patient safety.
It is important to note that devices like the LXcan and LXplus are not included in this list. Therefore, they are not subject to the same requirements for metrological inspections as the devices mentioned in Appendix 2. This means that operators of LXcan or LXplus luminance meters are not obligated to perform regular metrological inspections.