IEC 63322-ed.1.0

Podrobné informace

Označení: IEC 63322-ed.1.0

Datum vydání: 28.07.2025

Stran: 0

Země: Mezinárodní technická norma

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Anotace

IEC 63322:2025 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 IAEA are subject to this document. The object of this document 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 SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document 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 document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment. LIEC 63322:2025 definit les exigences de securite relatives aux APPAREILS EM qui utilisent des SOURCES RADIOACTIVES SCELLEES de haute activite, directement ou indirectement, pour un traitement medical et dautres procedures cliniques. Les APPAREILS EM qui contiennent des SOURCES RADIOACTIVES SCELLEES definies comme SOURCES RADIOACTIVES de Categorie 1, 2 et 3 par lAIEA [6] sont soumis au present document. Lobjet du present document est de specifier les exigences relatives a la securite des APPAREILS EM qui contiennent des SOURCES RADIOACTIVES SCELLEES de haute activite dans le but de reduire le plus possible le risque dacces non autorise aux SOURCES RADIOACTIVES SCELLEES contenues, et de servir de base a dautres normes. Le present document contient des exigences pour le FABRICANT des APPAREILS EM et, separement, pour lORGANISME RESPONSABLE en ce qui concerne la securite sur le site pendant lutilisation et le stockage. Les exigences du present document sappliquent lorsque les SOURCES RADIOACTIVES SCELLEES sont contenues dans les APPAREILS EM, cest-a-dire a partir du moment auquel les SOURCES RADIOACTIVES SCELLEES sont inserees dans les APPAREILS EM, pendant lUTILISATION PREVUE et lorsque les APPAREILS EM ne sont pas employes pour leur UTILISATION PREVUE ou sont retires de lutilisation normale, jusqua leur mise hors service, cest-a-dire jusquau retrait definitif de toutes les SOURCES RADIOACTIVES SCELLEES des appareils.