ISO/IEC FDIS 80601-2-58
Medical electrical equipment — Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
| Organization: | ISO |
| Publication Date: | 13 October 2023 |
| Status: | pending |
| Page Count: | 37 |
| ICS Code (Ophthalmic equipment): | 11.040.70 |
scope:
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 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 document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:20
NOTE See also 4.2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:20
Document History
