Legal basis:

The purpose of routine measurements of Dose Area Product or entrance dose is to help in achieving an overall reduction in the radiation received by patients undergoing medical radiological examinations. Provided adequate records are kept, it is possible to determine patient effective doses and to compare different examination techniques. In this respect, such measurements have tended to indicate a deterioration in the efficiency of the image-production system. Therefore, Dose Area Product Meters and Entrance Dose or Entrance Dose Rate Meters must be of a quality that fulfill the special needs defined in the International Performance Standards for diagnostic X-ray systems (according to IEC 60580, FDA publication: Amendments to the Performance Standard for Diagnostic X-Ray Systems).

These International Standards lay down the stipulations for  the performance testing of Dose Area Product Meters with Ionisation Chambers intended to measure the Dose Area Product and/or Entrance Dose Rate to which the patient is exposed during medical radiological examinations.

According to the "Council Directive 97/43/EURATOM of 30 June 1997 on health protection for individuals against the dangers of ionizing radiation in relation to medical exposure" every member state of the European Community has to publish diagnostic reference levels for radiodiagnostic examinations (Article 4, Optimisation, No. 2 (a)).
The easiest way to determine these reference levels is the use of Dose Area Product Meters.

According to this Council Directive 97/43/EURATOM it is also obligatory that every new radiodiagnostic X-ray installation shall have

"A device informing the practioner of the quantity of radiation produced by the equipment during the radiological procedure". (Article 8, Equipment No. 6)

This is usually realized by the installation of a Dose Area Product Meter system. Our KermaX plus systems offer a quick and easy solution.

This Council Directive 97/43/EURATOM of 30 June 1997 must be implemented into the National Law of each EC member state.

In addition, some member states of the European Community have laid down in their national laws that several types of already installed X-ray units must be retrofitted with such a Dose Area Product Meter. Other will follow soon. Please contact us for detailed information regarding legal situations in different countries.