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IEC 61847:1998 ed1.0
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
31 стр.
Действует
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Разработчик:
Зарубежные/IEC
ICS:
11.040.01 Medical equipment in general / Медицинское оборудование в целом17.140.50 Electroacoustics. Including sound level meters / Электроакустика. Включая слуховые аппараты и шумомеры
Описание
This standard specifies:- the essential non-thermal output characteristics of ultrasonic surgical units;- methods of measurement ot these output characteristics;- those characteristics which should be declared by the manufacturers of such equipment.This 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; andb) 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; andc) 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.