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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 056 Date of Entry 06/07/2021 
FR Recognition Number 10-126
Standard(Included in ASCA)
IEC  80601-2-58 Edition 2.0 2014-09
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
Identical Adoption
ANSI AAMI IEC 80601-2-58:2014
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
Scope/Abstract
IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.
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FDA recognition of IEC 80601-2-58 Edition 2.0 2014-09 [Rec# 10-126] will be superseded by recognition of IEC 80601-2-58 Edition 3.0 2024-03 [Rec# 10-136].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
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  claudine.krawczyk@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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