
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
出版:National Standards Authority of Ireland

专家解读视频
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.
IEC 80601-2-58 : 2.0 - Identical
EN 80601-2-58 : 2015 - Identical
EN 80601-2-58:2015/A1:2019 - Identical
IEC 80601-2-58 : 2.0 : AMD 1 - Identical
IEC 80601-2-58 : 2.0 - Identical