Amendment 1 - Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

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.

Amendement 1 - Appareils électromédicaux - Partie 2-58: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique

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Publication Date
19-Oct-2016
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IEC 80601-2-58:2014/AMD1:2016 - Amendment 1 - Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
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IEC 80601-2-58
Edition 2.0 2016-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1

Medical electrical equipment –
Part 2-58: Particular requirements for the basic safety and essential performance
of lens removal devices and vitrectomy devices for ophthalmic surgery

Appareils électromédicaux –
Partie 2-58: Exigences particulières pour la sécurité de base et les performances
essentielles des dispositifs de retrait du cristallin et des dispositifs de
vitrectomie pour la chirurgie ophtalmique

IEC 80601-2-58:2014-09/AMD1:2016-10(en-fr)

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