BS EN 60601-2-43:2022

Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | Status: Current

201.1 Scope, object and related standards Clause 1 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 applies, except as follows:

201.1.1 * Scope

Replacement: This document 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 document 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 document; 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 document and not by IEC 60601‑2‑44[1]1. No additional requirements for operation in cone-beam CT mode were identified for this document (see also Note 5 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 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.

201.1.2 Object

Replacement: The object of this document is:

• — to establish particular basic safety and essential performance requirements for the design and manufacture of X-ray equipment for radioscopically guided interventional procedures, as defined in 201.3.205.
• — to specify information which shall be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these radioscopically guided interventional procedures which could affect patients or staff.

201.1.3 Collateral standards

Addition: This document refers to those applicable collateral standards that are listed in Clause 2 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, as modified in 201.2. IEC 60601‑1‑2:2014 , IEC 60601‑1‑2:2014/AMD1:2020, IEC 60601‑1‑3:2008, IEC 60601‑1‑3:2008/AMD1:2013 and IEC 60601‑1‑3:2008/AMD2:2021 apply as modified in Clause 202 and Clause 203 respectively. IEC 60601‑1‑8 [2], IEC 60601‑1‑9[3], IEC 60601‑1‑10[4] do not apply.

NOTE Operators of interventional X-ray equipment are used to audible signals as specified in this document rather than the concepts of IEC 60601‑1‑8.

IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020[5] apply only if the manufacturer declares that the me equipment or me system is intended to be operated in a home healthcare environment, and otherwise do not apply. IEC 60601‑1‑12:2014 and IEC 60601‑1‑12:2014/AMD1:2020[6] apply only if the manufacturer declares that the me equipment or me system is intended to be operated in an emergency medical services environment, and otherwise do not apply. All other published collateral standards in the IEC 60601‑1 series apply as published.

201.1.4 Particular standards

Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements. A requirement of a particular standard takes priority over IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020. The numbering of clauses and subclauses of this particular standard corresponds to that of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 with the prefix "201" (e.g. 201.1 addresses the content of Clause 1 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020) or applicable collateral standard with the prefix "20x.101" where x is the final digit(s) of the collateral standard document number (e.g. 202.4 addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of the IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard are specified by the use of the following words: "Replacement" means that the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or the applicable collateral standard is replaced completely by the text of this particular standard. "Addition" means that the text of this particular standard is additional to the requirements of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or the applicable collateral standard. "Amendment" means that the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or the applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are numbered starting from 201.101. However, due to the fact that definitions in IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are numbered 3.1 through 3.154, additional definitions are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.