Manipulation requirements
The holder of the authorization or registry certificate must ensure that the appropriate maintenance and checking of the radiologic devices are realized so that the radiologic devices keep their nominal technical parameters during the whole lifetime of the devices according to the technical specifications of the manufacturer, for image quality, radioprotection and security.
The daily, weekly and monthly checkings of the radiologic device are performed according to manufacturer’s instructions by the medical physicist, and if the device is not compliant the authorized service unit will be immediately called.
All the procedues used for the above mentioned checkings are part of the user’s quality assurance program.
The checkings will have records that will be kept for control during at least 5 years.
All manipulation procedures (installation-assembling, verification, maintenance, service, repair, scrapping/dismantling, etc.) must be included in the qualitaty assurance program of the authorized unit for the manipulation activity.
The service reports which describe the findings regarding the technical condition, as well as the records related to interventions subsequent to these findings to bring the device back in nominal technical parameters, will be backed up as part of the quality assurance program.
During the manipulation operations (installation, assembling, checking, maintenance, service, repair) an expert in radioprotection or medical physics must participate from the beneficiary’s side and ensure that the device is in security conditions.
After any repair and at any periodical checking, performed at intervals no longer than one year, the company authorized for the manipulation of the devise will issue a checking report of the compliance of the device with the nominal technical parameters.
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