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;
– 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.
Required fields are indicated with *
