prEN IEC 63322:2024

1.1 Scope
This document establishes security requirements of ME EQUIPMENT using high activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures.
ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3
radioactive sources by IAEA1 are subject to this standard.
1.2 Object
The object of this standard is to specify requirements for the security of ME EQUIPMENT containing high activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained RADIOACTIVE SOURCES, and to serve as the basis for particular standards. This standard contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage.
The requirements of this standard apply when the RADIOACTIVE SOURCE(s) are contained in the ME EQUIPMENT, i.e. from the time when the RADIOACTIVE SOURCE(s) are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED PURPOSE or taken out of regular use, until the equipment is being decommissioned, i.e. until all RADIOACTIVE SOURCE(s) are permanently removed from the equipment.