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Publication details

Publication CODE Title
IEC 80601-2-58:2014+AMD1:2016 CSV (2016-10) 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
 
Price Excl. VAT Total number of pages, tables and drawings
318.00 € 133 P..
Description
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.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Withdrawn
Replaced by  IEC 80601-2-58:2024
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2016-10-20
ICS-Code (International Standards Classification) 11.040.70
NBN Status New
IEC publication date 2016-10-20
IEC stability date 2024-12-31
IEC file modification date 2016-10-19
IEC last modification date 2017-05-10