CLERAD

This product or service is available only for the French Market !

The European legislation as regards protection against radiation is governed by Euratom Treaty and its directives. These last are legal texts whose objectives bind the Member States while leaving to each one freedom choose the manner of transposing them in national law.

Directive 97/43 Euratom, relating to the health protection during exposures to medical ends, reaffirms the fundamental objectives, namely to obtain a maximum of effectiveness in diagnosis with an amount of radiations which is acceptable for the patient and reduces the number of inappropriate exposures.

These objectives are contained in the requirements stated for 4 different fields:
 qualifications and responsibilities entrusted to the personnel for the medical installations
 the equipment
 procedures
 "special practices"

The transposition in French right of this directive gave place to Decree 2001-1154 of December 5, 2001 imposing maintenance and the quality control of the medical devices. The quality control of a medical device represents, in this case, the whole of the operations intended to evaluate the maintenance of the performances fixed by the AFSSAPS (French Agency of Medical Safety of the Products of Health). The dental surgeons using radiography with x-rays for their diagnosis must thus subject their apparatus to a maintenance action, a quality control internal and an external quality control.

Company CLERAD proposes to the dental surgeons several services to help them to integrate the new regulation.
 Assistance with the installation of the Internal Quality control.
 External Quality control of the apparatuses of imagery and emission of a certificate of control.
 the Councils and studies in protection against radiation.

The controls carried out by CLERAD cover, as well in intra-oral radiology as panoramic or cephalometric (in the case of numerical and analogical): (analogical or numerical)

 the administered dose with the patient (justification, optimization and limitation of amount)
 the radiological apparatus (X-ray emitting tube, beam, layer half-value, high voltage...)
 the quality of the image (blackening, contrast...)
 the receiver of image (films, sensors, development and darkroom)

The parameters to be controlled and their criteria of acceptability not being fixed yet at the lawful level, CLERAD developed its controls using guides provided by the European Commission as while taking as a starting point those establish by the other countries subjected to directive 97/43 Euratom and by adapting them to the French standards.