Standards Development

Scope

Clause 1 of the general standard IEC 60601-1 applies, except as follows:

Addition:

This International Standard applies to the basic safety and essential performance of high intensity therapeutic ultrasound equipment as defined in 201.3.218, hereafter referred to as me equipment.

This standard can also be considered for:

– equipment for blood brain barrier opening through exposure to therapeutic ultrasound;

– equipment for neuro nerve modulation through exposure to therapeutic ultrasound;

– equipment for aesthetic and cosmetic applications through exposure to therapeutic ultrasound.

This particular standard does not apply to:

 ultrasound equipment intended to be used for physiotherapy (use: IEC 60601-2-5 [[1]] and IEC 61689);

 ultrasound equipment intended to be used for lithotripsy (use: IEC 60601-2-36 [[2]]);

 ultrasound equipment intended to be used for dedicated hyperthermia devices;

 ultrasound equipment intended to be used for surgical/cutting procedures (IEC 61847).

Replacement:

The object of this particular standard is to establish particular basic safety and essential performance requirements for high intensity therapeutic ultrasound (HITU) equipment as defined in 201.3.218.

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.

All published collateral standards in the IEC 60601-1 series apply as published.

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 particular 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.