IEC 63322:2025 pdf download,Security of ME equipment containing high-activity sealed radioactive sources.
IEC 63322:2025 outlines the security requirements for medical equipment (ME EQUIPMENT) that utilizes high-activity sealed radioactive sources in various medical treatments and clinical procedures. This standard specifically applies to ME EQUIPMENT containing sealed radioactive sources classified as Category 1, 2, and 3 by the International Atomic Energy Agency (IAEA).
The primary objective of this document is to establish stringent security measures for ME EQUIPMENT that houses high-activity sealed radioactive sources. These measures aim to minimize the risk of unauthorized access to these sources, thereby enhancing safety and security in medical settings. Additionally, this standard serves as a foundational reference for other related standards.
The document delineates specific security requirements for both the manufacturers of the ME EQUIPMENT and the responsible organizations that oversee security during the equipment’s use and storage. The requirements are applicable from the moment the sealed radioactive sources are integrated into the ME EQUIPMENT, throughout its intended use, and during periods when the equipment is not actively in use or is taken out of service. This includes the entire lifecycle of the equipment until it is decommissioned, which entails the permanent removal of all sealed radioactive sources.
By adhering to IEC 63322:2025, stakeholders can ensure that appropriate security protocols are in place, thereby safeguarding against potential risks associated with the handling and storage of high-activity sealed radioactive sources in medical environments.