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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

Available format(s)

Hardcopy , PDF

Language(s)

English - French

Published date

09-16-2019

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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.

Committee	TC 62
DocumentType	Standard
ISBN	978-2-8322-3568-3
Pages	0
ProductNote	NOTE: The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN 80601-2-58:2015

Standards	Relationship
IEC 80601-2-58:2014	Identical
EN 80601-2-58:2015	Identical
EN 80601-2-58:2015/A1:2019	Identical
IEC 80601-2-58:2014/AMD1:2016	Identical