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IEC 80601-2-58-ed.2.1
Medical electrical equipment - Part 2-58: Particular requirementsfor the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
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STANDARD published on 20.10.2016
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The information about the standard:
Designation standards: IEC 80601-2-58-ed.2.1
Publication date standards: 20.10.2016
SKU: NS-666582
The number of pages: 133
Approximate weight : 430 g (0.95 lbs)
Country: International technical standard
The category - similar standards:
Annotation of standard text IEC 80601-2-58-ed.2.1 :
IEC 80601-2-58:2014+A1:2016 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 commentssubmitted 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. This consolidated version consists of the second edition (2014) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication. LIEC 80601-2-58:2014+A1:2016 sapplique a la securite de base et aux performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique et des accessoires lies qui peuvent etre raccordes a ces appareils electromedicaux, designes ci-apres comme appareils EM. Les dangers inherents a la fonction physiologique prevue de lappareil EM ou des systemes EM dans le cadre du domaine dapplication de la presente norme ne sont pas couverts par des exigences specifiques contenues dans la presente norme, a lexception de 7.2.13 et 8.4.1 de la norme generale. Cette seconde edition contient des changements permettant de prendre en compte les commentaires soumis durant lapprobation de la premiere edition en tant que Directive Medicale Europeenne, ainsi que des commentaires dautre Comites Nationaux soumis lors de la finalisation de la premiere edition de cette norme. Cette version consolidee comprend la deuxieme edition (2014) et son amendement 1 (2016). Il nest donc pas necessaire de commander lamendement avec cette publication.
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