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Publication details

Publication CODE Title
NBN EN 80601-2-58:2015 (2015-05) 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
25.00 € 4 P..
Description
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
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally only available in English or French. Only the cover page is translated and the document itself is in English or in French.

Very important notice: 98% of the text of the NBN EN 55XXX, NBN EN 6XXXX comes from the IEC text which is NOT included. This text can be ordered here: IEC 80601-2-58:2014. For the series NBN EN 50XXX, the standards are however complete.

EN version
DE version
FR version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Currently active
Replaces  NBN EN 80601-2-58:2009
Replaces  NBN EN 80601-2-58:2009/A1:2011
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2014-10-09
NBN Approval 2015-07-24
Belgian Official Journal 2015-08-13
Registration 158337
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040.70
NBN Status New
Date of ratification (d.o.r.) 2014-10-09
Date of availability (d.a.v.) 2015-05-29
Date of announcement (d.o.a.) 2015-08-29
Date of publication (d.o.p.) 2015-11-29
Date of withdrawal former edition (d.o.w.) 2018-05-29
Correspondences with international standards
Relation International standard Date
is identical to EN 80601-2-58:2015 2015-05-29
is identical to IEC 80601-2-58:2014/ed. 2.0 2014-09-04
Relations to belgian/foreign publications
Type Origin Code Date
Standard Belgium NBN EN 60601-1-2:2007
Standard Belgium NBN EN 60601-2-2
Standard Belgium NBN EN 60601-2-22
Standard Belgium NBN EN ISO 11607-1:2009
Standard Belgium NBN EN ISO 11607-2:2006
Standard Belgium NBN EN ISO 17664:2004