| 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
|
|
| Committee |
TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
|
| Responsible |
De heer VAN HECKE Luk
|
| 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 |
|
