The development, production, sale and use of all medical products underlie various regulations depending on equipment dedicated use and country where it is build, sold and used. It its a problem of international manufactures to meet different regulations and standards in different countries.

International Standard Organisations like IEC and ISO work on the harmonisation of these standards throughout the world. For the German market Diagnostic Ultrasound Equipment has to fulfil either MedizinProdukte-Betreiber-Verordnung (MPBetrVO) or Medizin-Produkte-Gesetz (MPG) which imply the European guidelines 93/42/EWG. Starting 13.06.1998 MPBetrVO becomes obligatory.

These regulations imply IEC 601 Medical electrical equipment; general requirements for safety and the European guideline 89/3336 EWG electromagnetic requirements. The German health insurance system has additional regulations due to the guidelines of the Kassenärztliche Bundesvereinigung KBV. These guidelines demand diagnostic ultrasound equipment to fulfil IEC 1157 and performance criteria not implied in the other standards and regulations.

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