München – Medical products or medical devices must be checked regularly. TÜV SÜD points this out. The basis for the tests is the Ordinance on the Installation, Operation and Use of Medical Products (MPBetreibV). There are also other test specifications from trade associations and insurance companies.
For medical devices, the MPBetreibV prescribes recurring tests at certain intervals to protect patients and staff. The ordinance distinguishes between safety checks (e.g. of defibrillators, infusion or respirators) and metrological checks (e.g. of blood pressure monitors, thermometers or audiometers). “In addition, there are tests of electrical equipment such as multiple sockets or lights according to the regulations of the employers’ liability insurance association (DGUV) and the specifications of various insurance companies,” explains Arnold Staedel, Head of the Electrical and Building Services Division at TÜV SÜD Industrie Service GmbH. “These tests are about, among other things, preventing fires caused by overloading or short circuits, for example.”
According to MPBetreibV, a safety check must be carried out at least every two years and may only be carried out by sufficiently trained personnel with the necessary testing experience. “Since metrological controls and DGUV tests also have to be carried out regularly, it makes sense to combine all the prescribed tests in one appointment,” explains Arnold Staedel. “In this way, the operators can reduce their effort and the downtime of their devices to the necessary minimum.” The requirements for the testers are specified in VDI 5707, which has just been published. It contains, for example, specifications regarding vocational training, professional experience and a recent professional activity.
TÜV SÜD not only offers the testing of medical devices, but also supports operators with the free online platform netinform in filing test reports and legally compliant documentation and in complying with test deadlines. Further information on the testing of medical devices and the online platform netinform is available on the Internet at www.tuvsud.com/de-stk, www.tuvsud.com/de-mtk and www.tuvsud.com/netinform.