CSA C22.2 NO. 80601-2-58:15 (R2020)

This is the second edition of CAN/CSA-C22.2 No. 80601-2-58, 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, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-58 (second edition, 2014-09). It supersedes the previous edition published in 2010 as CAN/CSA-C22.2 No. 80601-2-58 (adopted IEC 80601-2-58:2008). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 80601-2-58” throughout.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005+A1:2012, with Canadian deviations).

Scope and object:

201.1.1 Scope:

This International Standard 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.

NOTE See also 4.2 of the general standard.

201.1.2 Object:

The object of this particular standard is to establish 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.