ANSI/AAMI/IEC 80601-2-58:2014 pdf download.Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery.
201.1 Scope, object and related standards
Clause 1 of the general standard1 applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOWY 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 subelause 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 specitic 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
Replacement:
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.
201.1.3 Collateral standards
Addition:
This particular standard reters to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2007 applies as modfied in Clause 202. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601 -1 is referred to in this particular standard as the “general standard”.Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201 ” (e.g. 201 .1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601 -1 -2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601 -1 -3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: ”Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.ANSI/AAMI/IEC 80601-2-58 pdf download.