IEC 60601-2-43-2017 醫用電氣設備--第2-43部分:介入操作X射線(xiàn)設備的基本安全和基本性能專(zhuān)用要求 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 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 standard 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 particular standard; 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 in cross-sectional imaging mode (sometimes described as
2
CT-like mode or cone-beam CT) is covered by this particular standard and not by IEC 60601-2-44 [2] . Additional
requirements for operation in CT-like mode or cone-beam CT were not considered in the present standard.
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
standard.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY
 only, or to ME SYSTEMS only, the title and content of that clause or subclause will
EQUIPMENT
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.
NOTE 4 See also 4.2 of the general standard.dition 2.1 2017-05 CONSOLIDATED VERSION VERSION CONSOLIDéE colour inside Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures Appareils électromédicaux – Partie 2-43: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X lors d’interventions IEC 60601-2-43:2010-03+AMD1:2017-05