This International Standard specifies:
– the essential non-thermal output characteristics of ultrasonic surgical units;
NOTE 1 – One of the parameters of interest is output acoustic power. This standard primarily addresses the low-frequency (under 120 kHz) component of the total delivered energy. The high-frequency component, which relates to cavitation developed at the tip, is discussed but not required as a reported parameter (see A.4). However, the vibration amplitude at which cavitation occurs shall be measured, noted and reported
– 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 a straight tubular shape is used in the basic description of the parameters and measurements to be made. Guidance is provided to the user of this standard to adapt the basic methodology described to more complex designs as required. It is recognized that complex designs and vibration patterns are design features of many surgical devices, and therefore it is important that output characteristics be declared for those conditions. The manufacturer is required to declare which vibrational modes and excursion directions are under user control, and provide information on all such modes.
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 120 kHz; and
b) ultrasonic surgical systems, whose use is the fragmentation, emulsification, debridement, 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, phacoemulsifiers, intracorporeal lithotripters, end-cutting devices, ultrasonic liposuction devices, etc. Devices which do not make direct contact with the surgical or wound site are covered by this Standard, although the acoustic power calculation must be modified to account for the acoustic characteristics of air rather than tissue.
NOTE 4 – The upper frequency limit has been set to accommodate more recently developed devices operating at higher frequencies than the original standard. The requirements and techniques of this standard are also applicable to devices operating at higher frequencies that use the same mechanisms of action.
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