Applying For A New Licence
New practices or practices introducing x-ray apparatus for the first time must apply to the EPA-ORM for a licence. It is important that a licence “for custody & commissioning” is obtained prior to the installation of the equipment. The steps involved in applying for a licence are as follows.
1. Register as a user on EDEN www.edenireland.ie, which is the EPA on-line licensing system”.
2. Appoint a registered Radiation Protection Advisor (RPA). The RPA shall review the design and layout of the proposed facility and provide a Risk Assessment and draft radiation Safety Procedures.
3. Apply for a licence on-line. See Instructions on the EPA Website www.edenireland.ie. Documentation including the RPA Risk assessment, radiation Safety procedures, Floor Plans, etc, must be uploaded on the Documentation section of EDEN as part of the application process
4.Provided that all documentation is in order, a licence will be issued authorizing the practice to take custody of the x-ray unit(s). The licence will list details of the equipment in schedule 2, with a licensing restriction specifying “for commissioning only”. It should be noted that this restricts use of the X-ray unit(s) to commissioning & testing by the installer and the RPA. When this licence has been received, make arrangements with the supplier to have the equipment delivered, and with the RPA to have it commissioned.
5. For Medical/Dental Equipment, the RPA must provide a Commissioning Report, or in the case of industrial Equipment, the supplier must provide a Commissioning/Installation Report. These reports must be uploaded to EDEN under the Documentation section, requesting that the licensing restriction be removed. Assuming that the commissioning report indicates that performance and safety of the equipment/installation is satisfactory, the ORM will issue an updated schedule 2 with the licensing exception removed.
6. The equipment is now licensed for use, subject to compliance with all licence conditions”. X-Spect Limited will perform a post-installation Compliance & Quality Audit as part of the RPA service.