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This document (CEN ISO/TS 14265:2023) has been prepared by Technical Committee ISO/TC 215 "Health informatics" in collaboration with Technical Committee CEN/TC 251 "Health informatics" the secretariat of which is held by NEN (Netherlands). Compared to the previous edition from 2014, the list of categories and their hierarchical structure in particular have been expanded. The responsible German standardization committee is Working Committee NA 176-02-04 AA "Sicherheit" ("Safety") at DIN Standards Committee Health Technologies (NAGesuTech).