ISO/TR 22979:2017 Preview

Ophthalmic implants -- Intraocular lenses -- Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.


General information

  • Status :  Published
    Publication date : 2017-05
  • Edition : 2
    Number of pages : 22
  • :
    ISO/TC 172/SC 7
    Ophthalmic optics and instruments
  • 11.040.70
    Ophthalmic equipment

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