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Publication details

Publication CODE Title
NBN EN 80601-2-58:2009 (2018-05) 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 € 5 P.
Description
Establishes 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.
Class  C74  (EQUIPMENT USING ELECTRICAL POWER RADIOLOGY AND SIMILAR ELECTRICAL APPLIANCES AND THEIR ACCESSORIES)
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 80601-2-58:2008. For the series NBN EN 50XXX, the standards are however complete.

EN version
FR version
NL version
DE version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Withdrawn
Replaced by  NBN EN 80601-2-58:2015
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2009-02-01
NBN Approval 2009-10-30
Belgian Official Journal 2009-12-09
Registration 96474
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040.70
NBN Status Adapted
Date of ratification (d.o.r.) 2018-05-29
Date of availability (d.a.v.) 2018-05-29
Date of announcement (d.o.a.) 2009-05-01
Date of publication (d.o.p.) 2009-11-01
Date of withdrawal former edition (d.o.w.) 2012-02-01
Correspondences with international standards
Relation International standard Date
is identical to EN 80601-2-58:2009 2009-02-06
is identical to IEC 80601-2-58:2008/ed. 1.0 2008-10-01
Relations to belgian/foreign publications
Type Origin Code Date
Standard Foreign IEC 60601-2-22
Standard Foreign ISO 15752
Standard Belgium NBN EN 60601-1-2
Standard Belgium NBN EN 60601-2-2
Standard Belgium NBN EN 61847
Standard Belgium NBN EN ISO 11607-1
Standard Belgium NBN EN ISO 11607-2
Standard Belgium NBN EN ISO 17664