EN 80601-2-58

Area	Medical technology
title	Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance for lens removal equipment and vitreous humor removal equipment in ophthalmic surgery
Latest edition	2009-10
ISO	IEC 80601-2-58: 2008

The EN 80601-2-58 titled "Electrical Medical devices - Part 2-58: Particular requirements for basic safety and essential performance of devices for lens removal and equipment for vitrectomy in ocular surgery" is part of the series of standards EN 60601 (EN 60601 series is currently (status?) Being transferred to the EN 80601 series).

The DIN standard DIN EN 80601-2-58 is published by the German Institute for Standardization .

Within the framework of the VDE standards, the standard is classified as VDE 0750-2-58 , see DIN-VDE standards part 7 .

The ICS code classification is 11.040.70.

This supplementary standard regulates the special stipulations regarding the safety of lensectometry devices and vitrectomy devices used in eye surgery, as well as their essential performance characteristics. The purpose is to describe the features of basic safety, the essential performance features and tests and also to provide instructions for their application.

validity

The final version of the standard is to be used in accordance with the 3rd edition of DIN EN 60601-1 .

scope of application

This International Standard applies to the basic safety and the essential performance characteristics of lensectometry devices and vitrectomy devices for ophthalmic surgery and the associated accessories.

Lens removal devices and vitreous body removal devices are widely used in ophthalmology to perform anterior segment and posterior segment surgery on the human eye.

extra information

Previous standard: IEC 60601-2-58: 2007-10

The following changed requirements are contained in EN 80601-2-59 (extract):

Adaptation to the changed requirements of EN 60601-1 3rd Edition.