IEC 61847:1998 pdf download – Ultrasonics – surgical systems – Measurement and declaration of the basic output characteristics

IEC 61847:1998 pdf download – Ultrasonics – surgical systems – Measurement and declaration of the basic output characteristics.
— the essential non-thermal output characteristics of ultrasonic surgical units;
NOTE 1 — One of the parameters of interest is output acoustic power. This standard addresses only the low- frequency (under 100 kHz) component of the total delivered energy. The high.trequency component, which probably relates to cavitation developed at the tip, is not addressed (see A.4).
— methods of measurement of these output characteristics;
— those characteristics which should be declared by the manufacturers of such equipment.
NOTE 2 — In the interest of clarity, this standard does not address all of the complex surfaces and shapes possible for applicator tips. A straight tubular shape is used in the description of the parameters and measurements to be made. Itis lett to the user of this standard to adapt the basic methodology described to more complex designs if required.
This International Standard is applicable to equipment which meets the requirements of a, b and c below:
a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and
b) ultrasonic surgical systems, whose use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation:
and
C) ultrasonic surgical systems. in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.
NOTE 3 — Examples of these types of systems are surgical aspirators. intracorporeal lithotripters, end-cutting devices etc.
This International Standard is not applicable to:
— lithotripsy equipment which uses extracorporeally induced pressure pulses, focussed through liquid conducting media and the soft tissues of the body:
— surgical devices used as part of the therapeutic process (hyperthermia systems);
— surgical devices whose acoustic application areas are not at the end of a longitudinally vibrating applicator tip and therefore would not fit the monopole model used in this standard.
This International Standard does not deal with the effectiveness or safety of ultrasonic surgical systems.
NOTE 4 — Throughout this standard, the term accuracy means the overall uncertainty expressed at the 95 % confidence level.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All normative documents are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
IEC 60500:1974, IEC standard hydrophone
IEC 6 1205:1993, Ultrasonics — Dental descaler systems — Measurement and declaration of the output characteristics
5 General measurement requirements
5.1 OperatIng conditions
Measurements shall be performed with parameters set to values recommended by the manufacturer. The parameters to be considered are:
— ambient temperature;
— tip irrigant flow rate;
— tip vibration excursion;
— tip aspiration flow rate.
The parameters listed above are not set independently during actual surgical use. Therefore, when a particular surgical environment is to be studied, the parameters listed above shall be specified so that meaningful comparisons of performance can be made (see clause B.5).
5.2 Load conditions
5.2.1 For measurement of derived output acoustic power
Measurements of derived output acoustic power or output acoustic power shall be made using degassed water (see clause A.6 for rationale and references to degassing techniques) in a tank, lined with sound absorbing material and having a suitable size to render it essentially anechoic for the tip vibration frequency of concern i.e. free field condition, in addition, for devices which have suction available, sufficient flow through tip can be used to minimize the accumulation of bubbles on the front surface of the tip.