DIN EN 60601-2-17:2016-03

This standard applies to the basic safety and essential performance of remote-controlled, automatically-operated brachytherapy afterloading equipment. It establishes requirements for remote-controlled, automatically-operated afterloading equipment that contain and use only sealed beta, gamma, and neutron radioactive sources or X-ray tubes designed and constructed for use with remote-controlled, automatically-operated afterloading equipment. The requirements are to be followed by manufacturers in the design and construction of afterloading equipment for use in temporary brachytherapy procedures. The purpose of this standard is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such ME equipment. It places limits on the degradation of ME equipment performance, beyond which it can be presumed that a fault condition exists and where an interlock then operates to return the radioactive source(s) to the storage container(s) and afterwards to prevent continued operation of the ME equipment. These Particular Requirements amend and supplement DIN EN 60601-1 (VDE 0750-1):2007-07. 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.