BAS EN 61847:2011
Ultrazvučna oprema- Hirurški sistemi - Mjerenje i deklarisanje osnovnih izlaznih karakteristika
Опште информације
Статус: Важећи
Број страна: 37
Језик: Енглески
Издање: 1.
Метода усвајања: Proglašavanje
Датум објаве: 31.10.2011
Технички комитет:
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Апстракт
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; 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.
Животни циклус
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Изворни документ и степен усаглашености
- EN 61847:1998, идентичан
- IEC 61847:1998, идентичан