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ISO/TR 22979:2017

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

standard by International Organization for Standardization (Technical Report) , 05/01/2017

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Full Description

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.

 

Product Details

Published:
05/01/2017
Number of Pages:
28
File Size:
1 file , 1.2 MB
Same As:
BS PD ISO/TR 22979:2017
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO/TR 22979:2017

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

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  2. ISO/TR 22979:2006


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

    • Historical Version