Description of BS EN 60601-2-43:2010+A2:2020 2020

Clause 1 of the general standard¹⁾ applies, except as follows:

201.1.1 * Scope

Replacement:

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.

201.1.2 Object

Replacement:

The object of this particular standard 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 201.3.203.

• to specify information which is to 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 procedures which could affect patients or staff.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601‑1‑2 and IEC 60601‑1‑3 apply as modified in Clause 202 and Clause 203 respectively. IEC 60601‑1‑8 ^{3 )}, IEC 60601‑1‑9 ^{4 )}, IEC 60601‑1‑10 ^{5 )}, IEC 60601‑1‑11 ⁶ ) and IEC 60601‑1‑12 ⁷⁾ 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 the general standard 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 the general standard.

For brevity, IEC 60601‑1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral

standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or 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 the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard 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.

The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

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