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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 062 Date of Entry 05/29/2024 
FR Recognition Number 10-136
Standard(Included in ASCA)
IEC  80601-2-58 Edition 3.0 2024-03
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
This document 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;

e) adding the shadow light method in;

f) clarify test conditions for EMC requirements in;

g) updated Table D.4 references to include specific IEC references to the symbols and delete "Annex AA,";

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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of IEC 80601-2-58 Edition 2.0 2014-09 [Rec# 10-126] will be superseded by recognition of IEC 80601-2-58 Edition 3.0 2024-03 [Rec# 10-136]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-126] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 10-126] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.4150 Instrument, Vitreous Aspiration And Cutting, Battery-Powered Class 2 HKP
§886.4150 Instrument, Vitreous Aspiration And Cutting, Ac-Powered Class 2 HQE
§886.4150 Vitrectomy, Instrument Cutter Class 2 MLZ
§886.4670 Unit, Phacofragmentation Class 2 HQC
§886.4670 Needle, Phacoemulsification, Reprocessed Class 2 NKX
Relevant FDA Guidance and/or Supportive Publications*
Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)), Issued January 1997.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Claudine Krawczyk
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.