PD ISO/TR 22979:2017 PDF

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

Название (английский):

PD ISO/TR 22979:2017

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

Статус документа:: product.statusDraft
Формат:: Электронный (PDF)
Дата публикации:: 30 сентября 2017 г.
ICS:: 11.040.70
SKU:: PD ISO/TR 22979:2017

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Abstract

1 Scope This document 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.

PD ISO/TR 22979:2017 PDF

Abstract

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Abstract

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