BS EN 60601-2-43:2022 Medical electrical equipment - Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
201.1 Scope, object and related standards
Clause 1 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 applies, except as follows:
201.1.1 * Scope
Replacement:
This document applies to the basic safety and essential performance of both fixed and mobile X- ray equipment declared by the manufacturer to be suitable for radioscopically guided interventional procedures , hereafter referred to as interventional X- ray equipment . Its scope excludes, in particular:
— equipment for radiotherapy ;
— equipment for computed tomography ;
— A ccessories intended to be introduced into the patient ;