Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

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

201.1.1 Scope

Replacement:

This particular standard specifies the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, as defined in subclause 201.3.206.

LOW POWER EQUIPMENT as defined in subclause 201.3.202 is exempted from certain requirements of this standard.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SHORT-WAVE THERAPY EQUIPMENT as defined in 201.3.206.

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.

IEC 60601-1-3 does 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.