Abstract
PreviewISO/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.
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Status: PublishedPublication date: 2017-05
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Edition: 2Number of pages: 22
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- ICS :
- 11.040.70 Ophthalmic equipment
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std 1 124 | ||
std 2 124 | Paper |
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