In it are manuals, documents on training and Admissions staff, the results of MTK, PCs, as well as the VDE testing and also made repairs in writing enclosed and solid old gel. In case of damage or accident a full justification of all rules exists with the medical product guide and the insurance protection must be guaranteed. Deficiencies, which pose a safety risk for patients, users or third parties, must be resolved immediately. Visualization and confirmation of a successful technical safety check is attached a test badge the validated medical technology product. It indicates the year of the next necessary PCs or the validity period of the recent control safety. The corresponding test badge medicine technology PCs valid until “in the online shop of the brewes GmbH. metrological control (MTK) in addition to the technical safety is preserved control also the metrological control for medical devices is prescribed.” At a distance of 24 months must especially medical technology devices with a measuring function be checked. What was described earlier as calibration, aims to identify any variations in measurements.
These are based on the information held by the manufacturer in the instructions for use and limits of error. Should there be no corresponding information, apply the harmonized standards (European standards for products). Medical devices which undergo a MTK, are laid down in Appendix 2 of the demands in detail: sound and language audiometer medical electric thermometer & infrared radiation thermometer blood pressure monitors eye Tonometer therapy dosimeters diagnostic dosimeter crank Ergometer there is also the possibility that medical devices of a MTK must undergo, not listed in annex 2 of the demands. This is the case, if the necessity of a metrological control is prescribed by the manufacturer. Metrological controls, comparison measurements are performed either or does an orientation towards metrological standards. These Normals are allowed only small error limits and measurement uncertainties include (not more than one-third of the error limits specified by the manufacturer) and understandable must be subject to a national or international standard.