DIN EN 60601-2-64:2018-01

The present International Standard applies to the basic safety of medical light ion irradiation facilities, hereinafter referred to as ME equipment, used for the compensation or alleviation of an illness, injury or disability. These particular requirements, including type tests and acceptance tests, apply to the manufacture and to some installation aspects of medical light ion irradiation equipment that: - is intended for radiotherapy in human medical practice, including that in which the selection and display of operating parameters can be automatically controlled by programmable electronic subsystems (PESS); - under normal conditions (NC) and during normal use, a useful beam of light ions with - an energy per nucleon in the range from 10 MeV/n to 500 MeV/n; and - which are intended: - for its intended use under the supervision of appropriately licensed or qualified persons and when operated by operators with the necessary skills for a specific medical application, for special defined clinical purposes, such as standing field irradiation or motion irradiation; - maintenance in accordance with the recommendations in the instructions for use; - regular quality assurance tests with regard to performance and calibration by a qualified person. The responsible committee is DKE/GK 813 "Elektrische und mechanische Sicherheit in der radiologischen Technik" ("Electric and mechanical safety in radiological technique") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.