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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

21-09-2017

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Modifications to parent models
5 Considerations for the assignment of modification
level
6 Modifications of optical design features
7 Modifications to the mechanical design
8 Modifications to material
Annex A (informative) - Examples of modifications
to a parent IOL model
Annex B (informative) - Mechanical data analysis
Bibliography

Gives guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).

This document provides guidance on the application of all parts of the ISO11979 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 ISO14971 .^[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.

Committee	CH/172/7
DocumentType	Standard
Pages	30
PublisherName	British Standards Institution
Status	Current
Supersedes	PD ISO/TR 22979:2006

Standards	Relationship
ISO/TR 22979:2017	Identical

ISO 11979-10:2006	Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
ISO 11979-7:2014	Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 11979-3:2012	Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 11979-9:2006	Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
ISO 11979-8:2017	Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
ISO 11979-1:2006	Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 11979-4:2008	Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
ISO 11979-2:2014	Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 11979-5:2006	Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11979-6:2014	Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing

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PD ISO/TR 22979:2017

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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