Medical Technology

What is the inspection of medical technology? What laws and regulations must be observed? With medical technology is tested, whether a person is healthy or not, diseases treated and diagnoses made. But who checks the medical technology? Especially in this area are unique, correct measurements and results for each patient of great importance. An incorrect indication or a malfunction of medical equipment can cause serious consequences, such as unnecessary surgery or false methods of treatment. How important the regular review of medical technology, already shows the large number of laws, rules and regulations that deal with this topic: medical product Act (MPG), medical devices operator Ordinance (MPBetreibV) and operational safety Ordinance (BetrSichV) legal basis = BG rule BGV A3 = accident prevention regulation DIN VDE 0751 1, DIN EN 62353 and DIN VDE 0701/0702 = standards of the German Institute for Standardization (DIN) with their application meets the legal requirements and provisions in relation to the safety of electrical appliances Association regulations and instructions of the highest authorities of the country and of the Federal Institute for drugs and medical devices (BfArM) periodic check-up test periods of Elektrotechnik Elektronik Informationstechnik e.V. (VDE) are basically determined by the manufacturer of medical devices or systems and laid down in the relevant documents. The scope of the tests should be given in the accompanying document. If there are no provisions for testing, technical operator for this must ensure that appropriate checks at reasonable intervals are performed. These relate to the experience so far with the devices for example how often already defects occurred.

The setting of inspection periods can be made by an expert person, considering manufacturer notes. Periodic tests should be at a distance held between 6 and 36 months. A Mindestpruffrist is recommended for certain groups of devices, such as incubators for premature babies, 24 months. The test periods are always depending on the individual device.