Reference number
ISO/TR 22979:2017
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
Preview
ISO/TR 22979:2017
61830
No disponible en español
Publicado (Edición 2, 2017)

ISO/TR 22979:2017

ISO/TR 22979:2017
61830
Idioma
Formato
CHF 129
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2017-05
    : Norma Internacional publicada [60.60]
  •  : 2
     : 22
  • ISO/TC 172/SC 7
    11.040.70 
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