ISO/TR 22979:2017

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

Publication date: Apr 27, 2017

General information

Current stage: 60.60 Effective date: Apr 27, 2017

Originator: ISO

Owner: ISO/TC 172/SC 7

Type: Technical Report

ICS: 11.040.70

Languages: English

Buying

Status: Published

PDF - EC$373.24

Paper - EC$373.24

PDF and Paper - EC$746.48

Language

Language in which you want to receive the document.

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

Revises
ISO/TR 22979:2006

NOW

PUBLISHED
ISO/TR 22979:2017
60.60 Standard published
Apr 27, 2017

REVISED BY

IN_DEVELOPMENT
ISO/PWI TR 22979

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.