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Publication details

Publication CODE Title
NBN EN IEC 60601-2-43:2023 (2023-01) MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
 
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Description
This International Standard 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 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 for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 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 standard. 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. NOTE 4 See also 4.2 of the general standard. The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
Class  C
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally only available in English or French. Only the cover page is translated and the document itself is in English or in French.

EN version
FR version
Status
Status IEC PUBLICATION
Situation Currently active
Replaces  NBN EN 60601-2-43:2010
Replaces  NBN EN 60601-2-43:2010/A1:2018
Replaces  NBN EN 60601-2-43:2010/A2:2020
Replaces  NBN EN 60601-2-43:2010/AC:2014
Origin
Committee CLC/TC 62
Electrical equipment in medical practice
Approval
BEC Approval 2023-01-09
NBN Approval 2023-01-25
NBN Status New
Date of ratification (d.o.r.) 2023-01-09
Date of announcement (d.o.a.) 2023-04-09
Date of publication (d.o.p.) 2023-10-09
Date of withdrawal former edition (d.o.w.) 2026-01-09
IEC file modification date 2023-01-21