DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 80601-2-58
; VDE 0750-2-58:2025-03
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 (IEC 80601-2-58:2024); German version EN IEC 80601-2-58:2024
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und Geräte zur Glaskörperentfernung in der Augenchirurgie (IEC 80601-2-58:2024); Deutsche Fassung EN IEC 80601-2-58:2024
Overview
This International Standard applies to the basic safety and essential performance of lensectomy devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment. This document contains an update to the EMC requirements. Hazards arising from the intended physiological effects of ME devices or ME systems within the scope of this standard are not covered by particular requirements in this standard, except for 7.2.13 and 8.4.1. The standard differs from DIN EN 80601-2-58 (VDE 0750-2-58):2020-06 as follows: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete "Annex AA, 201.7.6.101"; h) adding of 201.12.1.101.7 to Annex AA; i) include a new annex to address the relevant general safety and performance requirements of European Regulation (EU) 2017/745 [1] (NOTE IEC: Numbers in square brackets refer to the references.) (Annex BB); j) remove all references of the liquefaction fragmentation lens removal method. In many parts of the world, lensectomy devices and vitrectomy devices are used in combination by eye surgeons to perform combined surgical procedures on the anterior segment (lens removal) and posterior segment (vitreoretinal = vitreous body/retina), thereby maximizing surgical outcomes. For this reason, both lensectomy devices and vitrectomy devices are covered in this International Standard.
