Standard

IEC 60601-2-43:2022 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.
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.
IEC 60601-2-43:2022 cancels and replaces the second edition published in 2010, Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER as in IEC 60601-2-54:2022;
b) several terms and definitions that are moved from IEC TR 60788:2004 to 201.3 of IEC 60601-2-54:2022 are also referenced from IEC 60601-2-54:2022.
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
d) the former subclause 201.11.101 “Protection against excessive temperature of X-RAY TUBE ASSEMBLIES” is removed since covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017, and the former subclause 201.11.102 is renumbered as 201.11.101, as in IEC 60601-2-54:2022;
e) to adopt changes in subclause 7.8.1 “Colours of indicator lights” in IEC 60601 1:2005/AMD2:2020, clarification of requirements is provided in 201.7.8.1 to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT, as in IEC 60601-2-54:2022;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.