IEC 60601-2-43-2017 医用电气设备--第2-43部分:介入操作X射线设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
- 标准类别:
- 标准大小:
- 标准编号:IEC 60601-2-43-2017
- 标准状态:现行
- 更新时间:2023-08-17
- 下载次数:次
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
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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
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