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Publications on the Medical Devices Act

We recommend that any person or institution carrying out metrological checks on medical devices according to the provisions of the Medizinprodukte-Betreiberverordnung (Medical Products Operating Ordinance) read the Leitfaden zur messtechnischen Kontrolle von Medizinprodukten mit Messfunktion (Guide to Metrological Checks of Medical Devices Having a Measuring Function – LMKM) (both available in German only).

To ensure the uniform implementation of the regulations on metrological checks of medical products having a measuring function according to the provisions of the Medizinprodukte-Betreiberverordnung, the use of the guide is recommended to verification authorities and all other persons and institutions carrying out such metrological checks. The guide was elaborated jointly by PTB and the verification authorities from all Federal States after consultation with the circles involved. The guide is constantly updated to take practical experiences into account; Version 2.2 (February 2009) is now available. As in the past, the guide has been published in two parts. Part 1 includes audiometers, thermometers, non-invasive sphygmomanometers, ocular tonometers and ergometers; Part 2 is dedicated to dosemeters for therapy and dosemeters for radiodiagnostics. Issue 2.2 has been updated, and the part on ocular tonometers has been fully revised. The amendments are described in Annex 2.