Reference number
ISO/TR 22979:2017
© ISO 2024
Technical Report
ISO/TR 22979:2017
Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
Edition 2
2017-05
Technical Report
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Published (Edition 2, 2017)

ISO/TR 22979:2017

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Format
CHF 129
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Abstract

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
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 22
  • Technical Committee :
    ISO/TC 172/SC 7
    ICS :
    11.040.70 
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