JWG 9 - TC 62/SC 62D/JWG 9

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.

IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.

IEC 80601-2-58:2008 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment.