EN IEC 80601-2-58:2024

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

Publication date:   Oct 15, 2024

Scope

<!-- NEW! -->IEC 80601-2-58:2024 is available as <a href="https://webstore.iec.ch/publication/92842">IEC 80601-2-58:2024 RLV</a> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.</br></br>IEC 80601-2-58:2024 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/AMD2:2020 and 8.4.1 of IEC 60601-1:2005.

IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous edition:

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) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB);

i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.