DIN EN IEC 60601-2-43:2024-02

X-ray equipment used for fluoroscopy-guided interventional procedures can expose patients and operators to higher levels of radiation than the doses normally encountered. One consequence of this may be the occurrence of deterministic damage if the procedures involve irradiation of localized areas on the patient with significant amounts of radiation. Another consequence may be a high contribution to the overall stochastic risk of radiation-induced cancers and so on for the patient. Yet another consequence is the need for the device functions to be available with minimal periods of loss of critical functions. The types of interventional procedures considered here are well established in the clinical field, for example in: - invasive cardiology, - interventional radiology, - interventional neuroradiology. This standard modifies and supplements DIN EN 60601-2-43 (VDE 0750-2-43):2010. It applies to X-ray equipment that the manufacturer declares as suitable for fluoroscopy-guided interventional procedures and which are referred to below as interventional X-ray equipment. Thus this standard contains additional requirements for X-ray equipment that are not covered by the standard DIN EN 60601-2-54 (VDE 0750-2-54). The standard differs from DIN EN 60601-2-43 (VDE 0750-2-43):2020-12 as follows: a) a new specific term, dose measuring device, is introduced to replace the general term dosimeter, as in IEC 60601-2-54:2022; b) several terms that were moved from IEC TR 60788:2004 to IEC 60601-2-54:2022, 201.3 are also referenced in 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 the manufacturer specifies them; d) former Clause 201.11.101 "Protection against excessive temperatures of X-ray tube assemblies" has been deleted as it is 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 clause 201.11.102 has been renumbered as 201.11.101, as in IEC 60601-2-54:2022; e) to incorporate changes in 7.8.1 "Colors of signal lamps" in IEC 60601-1:2005/AMD2:2020, 201.7.8.1 includes explanations of requirements to avoid contradictions with requirements for signal lamps specified for X-ray equipment, as in IEC 60601-2-54:2022; f) Annex AA includes an explanation of the term essential performance to emphasize the performance of the clinical function under normal conditions and under first fault conditions.