Scope
Addition:
This Particular Standard specifies the requirements for safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101.
This Particular Standard does not apply to:
- EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry);
- EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotrites) (for information refer to
IEC 60601-2-36);
- ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND pulse waves are used.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101.
1.3
Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety, as amended by its amendment 1 (1991) and amendment 2 (1995).
For brevity, Part 1 is referred to in this Particular Standard as the General Standard .
The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. 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 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.
Amendment means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
The term this standard is used to make reference to the General Standard and this Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
The requirements of this Particular Standard take priority over those of the General Standard and Collateral Standards mentioned below.
1.5
Collateral Standards
Addition:
The following Collateral Standards apply:
IEC 60601-1-1:1992, Medical electrical equipment - Part 1: General requirements for safety - Section 1 - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:1993, Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral Standard: Programmable electrical medical systems
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