BS EN 80601-2-58:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 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 this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

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.


Cross References:
IEC 60601-1-2:2007
IEC 60601-2-2
IEC 60601-2-22
ISO 11607-1:2006
ISO 11607-2:2006
ISO 17664:2004
EN 60601-1-2:2007
EN 60601-1-2:2007+corr. March:2010
EN 60601-2-2
EN 60601-2-22
EN ISO 11607-1:2009
EN ISO 11607-2:2006
EN ISO 17664:2004
93/42/EEC
IEC 60065:2001
IEC 60825-1
IEC 60950-1
IEC 61847
ISO 15004-2:2007
ISO 15752:2010
ISO/TR 16142:2006
EN 60065:2002
EN 60825-1
EN 60950-1
EN 61847
EN ISO 15004-2:2007
EN ISO 15752:2010


Replaces BS EN 80601-2-58:2009+A11:2011 which remains current

All current amendments available at time of purchase are included with the purchase of this document.