Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

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;
– ACCESSORIES intended to be introduced into the PATIENT;
– mammographic X-RAY EQUIPMENT;
– dental X-RAY EQUIPMENT.

NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this document is recommended, are given in Annex AA.

NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this document; therefore, no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements.

NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this document and not by IEC 60601-2-44 [1]1. No additional requirements for operation in cone-beam CT mode were identified for this document (see also Note 5 in 203.6.4.5).

INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT

SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this document.

If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.

IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of

IEC 60601-2-54 do not apply.