MSZ EN 80601-2-58:2015

Gyógyászati villamos készülékek. 2-58. rész: A szemészeti sebészetben használatos lencsekiemelő és vitrectomiás készülékek alapvető biztonságra és lényeges működésre vonatkozó követelményei (IEC 80601-2-58:2014)

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 (IEC 80601-2-58:2014)


Clause 1 of the general standard1 applies, except as follows: Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 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. NOTE See also 4.2 of the general standard. Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to the ME EQUIPMENT and are to be tested together or individually.

Általános információk

Érvényes
angol
: 2015-12-01

11.040.70 - Szemészeti eszközök

MSZT/MB 843  Gyógyászati villamos készülékek

: idt EN 80601-2-58:2015; idt IEC 80601-2-58:2014

: MSZ EN 80601-2-58:2015/A1:2020

Vásárlás

: 9 470,0 Ft
(papír , PDF-fájl-letöltés)



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MSZ EN 80601-2-58:2015

2015-12-01

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