2.3 Radiotherapy equipment requirements
In medical exposures for therapeutic purposes, will be used only radioactive sources and radiotherapy devices which:
a) have Medical Device Certificate, issued by the MoH, according to Law No. 176/2000, republished or Medical Device Registration Certificate at the utilization site, issued by NAMMD, conform reglementarilor MS;
b) have Radiologic Security Authorization (RSA), issued by NCNAC, according to Law No. 111/1996, with subsequent modifications and completions;
c) are periodically tested, according to manufacturer’s requirements and RSA conditions, in order to check their compliance with the nominal technical parameters.
According to Art. 59 of the Radiologic Security Norms – Authorization Procedures, the technical documentation for radiological security authorization of a radiotherapy device must demonstrate that the radiological security requirements in design and manufacturing of the device are fulfilled.
The radiological security requirements in design and manufacturing of radiotherapy devices are mentioned in Annex No. 6. of RSN-12.
Dostları ilə paylaş: |
