Singapore legislation
Regulation 29
of Radiation Protection (Non-Ionising Radiation) Regulations
Regulation 29
Requirements for labelling of ultrasound apparatus
Subregulation 1
Every ultrasound apparatus shall, on the external surface of its housing, bear the following information and instructions:
the name and address of the manufacturer;
the name and address of the distributor, if the distributor is not the manufacturer;
the type and model designation;
the serial number;
the month and year of manufacture;
the ultrasonic frequencies in kilohertz (kHz) or megahertz (MHz);
a statement indicating whether the wave produced by the apparatus is a continuous wave or an amplitude modulated wave;
in the case of an apparatus that produces an amplitude modulated wave —
the pulse repetition rate, the pulse duration, the ratio of the temporal maximum effective ultrasonic intensity to the temporal average effective ultrasonic intensity, and a description of the wave shape, where these parameters do not vary depending on the power; and
the pulse repetition rate, the pulse duration, the ratio of the temporal maximum effective ultrasonic intensity to the temporal average effective ultrasonic intensity, and a description of the wave shape, all at temporal maximum ultrasonic power where these parameters vary depending on the power; and
the line voltage used for normal operation.
Subregulation 2
Every ultrasound apparatus shall, on the external surface of each applicator, bear the following:
the identification of the type and model of the ultrasound apparatus for which it is designed;
where an applicator is a focusing applicator, the focal length and the focal area;
a unique serial number or other unique identification; and
the effective radiating area in cm2.
Subregulation 3
Every ultrasound apparatus shall, on the external surface of its housing, have a radiation warning sign that —
is shown in 2 contrasting colours;
has no outer dimensions less than 2 cm;
is clearly visible and identifiable form 1 m;
bears the words “CAUTION — ULTRASOUND”; and
contains warning instruction regarding the danger of exposure to liquid-borne ultrasound for operator carrying out operations with ultrasonic cleaning tanks.