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IEC 60601-2-2-ed.6.0
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Translate name
STANDARD published on 31.3.2017
The information about the standard:
Designation standards: IEC 60601-2-2-ed.6.0
Publication date standards: 31.3.2017
SKU: NS-680843
The number of pages: 186
Approximate weight : 589 g (1.30 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-2-ed.6.0 :
IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - refinement and additions to the defined terms; - additional separation of the requirements for HF surgical equipment and HF surgical accessories; - a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes; - new requirements for devices that have or use a high current mode. LIEC 60601-2-2:2017 s’applique a la securite de base et aux performances essentielles des appareils d’electrochirurgie HF et des accessoires delectrochirurgie HF. Les appareils d’electrochirurgie HF dont la puissance de sortie assignee est inferieure ou egale a 50 W (destines, par exemple, a la micro coagulation, a l’ophtalmologie ou a l’usage dentaire) sont exemptes de certaines exigences de la presente norme particuliere. Ces exemptions sont indiquees dans les exigences correspondantes. La presente norme particuliere a pour objet d’etablir des exigences particulieres relatives a la securite de base et aux performances essentielles des appareils d’electrochirurgie HF et des accessoires d’electrochirurgie HF. Cette sixieme edition annule et remplace la cinquieme edition parue en 2009. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: - des precisions et des ajouts aux termes definis; - une separation supplementaire des exigences relatives aux appareils delectrochirurgie a courant haute frequence (HF) et aux accessoires delectrochirurgie a courant haute frequence (HF); - une nouvelle exigence concernant les electrodes neutres adultes devant servir delectrodes neutres de surveillance de la qualite du contact; - de nouvelles exigences relatives aux appareils ayant ou utilisant un mode de courant eleve.
These changes apply to this standard:
IEC 60601-2-2-ed.6.0/Amd.1
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Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
(Amendement 1 - Appareils electromedicaux - Partie 2-2: Exigences particulieres pour la securite de base et les performances essentielles des appareils d´electrochirurgie a courant haute frequence et des accessoires d´electrochirurgie a courant haute frequence)
Change published on 21.2.2023
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IEC 60601-2-2-ed.6.0/Amd.1/ISH1
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Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
(Feuille d´interpretation 1 - Amendement 1 - Appareils electromedicaux - Partie 2-2: Exigences particulieres pour la securite de base et les performances essentielles des appareils d´electrochirurgie a courant haute frequence et des accessoires d´electrochirurgie a courant haute frequence)
Change published on 21.11.2025
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