ISO/TR 22979:2017

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

Publication date: 27 pri 2017

General information

Current stage: 90.92 Effective date: 14 jan 2025

Originator: ISO

Owner: ISO/TC 172/SC 7

Type: Technical Report

ICS: 11.040.70

Gjuha: anglisht

Buying

Statusi: Publikuar

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/TR 22979:2006

NOW

PUBLISHED
ISO/TR 22979:2017
90.92 Standard to be revised
14 jan 2025

REVISED BY

IN_DEVELOPMENT
ISO/CD TR 22979