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Publication details

Publication CODE Title
NBN EN 80601-2-58:2015/A1:2019 (2019-08) 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
14.00 € 3.
Description
IEC 80601-2-58:2014 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 comments submitted 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.
Class  C
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation In preparation phase
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2019-08-07
NBN Approval 2019-09-25
ICS-Code (International Standards Classification) 11.040.70
NBN Status New
Date of ratification (d.o.r.) 2019-08-07
Date of availability (d.a.v.) 2019-08-23
Date of announcement (d.o.a.) 2019-11-23
Date of publication (d.o.p.) 2020-02-23
Date of withdrawal former edition (d.o.w.) 2022-08-23
Correspondences with international standards
Relation International standard Date
is identical to EN 80601-2-58:2015/A1:2019 2019-08-23
is identical to IEC 80601-2-58:2014/AMD1:2016 2016-10-20
Relations to belgian/foreign publications
Type Origin Code Date
Standard Belgium EN 55011
Standard Belgium EN 60601-1-2
Standard Belgium EN ISO 11607-1:2009/A1:2014
Standard Belgium EN ISO 11607-2:2006/A1:2014