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The provision that testing means are to be tested seems to be a typical example of an official decision but according to the Medical Devices Act which entered into force in 1998, medical instruments are marketed all over Europe without type approval. Since then the manufacturers and users have been responsible for the accuracy of the measurement results. With the CE mark the manufacturer certifies that his device was manufactured in accordance with the specified quality requirements. For regular metrological controls and above all for proper use the user is responsible. What requirements must be met by an ergometer which determines your personal fitness? And who controls the testing means of the controllers? At the PTB, the requirements are formulated, and the testing means for testing equipment are developed and used.
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