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About This Item

 

Full Description

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.
 

Document History

  1. IEC 80601-2-58 Ed. 3.0 b: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

    • Most Recent
  2. IEC 80601-2-58 Ed. 2.1 b:2016


    Medical electrical equipment - Part 2-58: Particular requirementsfor the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery CONSOLIDATED EDITION

    • Historical Version
  3. IEC 80601-2-58 Ed. 2.0 b:2014

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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

    • Historical Version
  4. IEC 80601-2-58 Ed. 1.0 b:2008


    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

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. IEC 80601-2-58 Amd.1 Ed. 2.0 b:2016


    Amendment 1 - 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