IEC 80601-2-58:2008

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

ISO/IEC 80601-2-58:2008 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 the medical electrical equipment, referred to in the document 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 says 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 ISO/IEC 80601-2-58:2008 are not necessarily covered by specific requirements in this International Standard.

The object of ISO/IEC 80601-2-58:2008 is to establish particular basic safety and essential performance requirements for lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to the ME equipment and are to be tested together or individually.

ISO/IEC 80601-2-58:2008 refers to those applicable collateral standards that are listed in Clause 2 of IEC 60601-1 and Clause 2 of this International Standard.


General information

  • Current status : Withdrawn
    Publication date : 2008-10
  • Edition : 1
    Number of pages :
  • :
    ISO/TC 172/SC 7
    Ophthalmic optics and instruments
  • 11.040.70
    Ophthalmic equipment

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