OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
Foreword to EN ISO 11979-9:2006
Foreword to EN ISO 11979-9:2006/A1:2014
1 Scope
2 Normative references
3 Terms and definitions
4 Physical requirements
5 Optical requirements
6 Clinical investigation
7 Information supplied by the manufacturer
Annex A (normative) - Optical characterization
Annex B (informative) - Clinical investigation
Annex C (informative) - Determination of sample
sizes for the clinical investigation
Bibliography

Pertains to any intraocular lens whose optic provides two or more powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).

DocumentType	Standard
Pages	23
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
NF EN ISO 11979-9 : 2006 AMD 1 2014	Identical
ISO 11979-9:2006	Identical
NBN EN ISO 11979-9 : 2006 AMD 1 2014	Identical
NEN EN ISO 11979-9 : 2006 AMD 1 2014	Identical
NS EN ISO 11979-9 : 2006 AMD 1 2014	Identical
I.S. EN ISO 11979-9:2006	Identical
SN EN ISO 11979-9 : 2006 AMD 1 2014	Identical
UNI EN ISO 11979-9 : 2014	Identical
BS EN ISO 11979-9 : 2006	Identical
EN ISO 11979-9:2006/A1:2014	Identical

DIN EN ISO 11979-1 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)
DIN EN ISO 11979-8 E : 2015	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
DIN EN ISO 11979-6 E : 2015	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
DIN EN ISO 11979-4 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
DIN EN ISO 11979-5 E : 2010	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 11979-3 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)

ISO 11979-7:2014	Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
DIN EN ISO 11979-2 E : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014)
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 11979-3:2012	Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO/TR 22979:2017	Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO 11979-1:2006	Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 11979-4:2008	Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
DIN EN ISO 11979-7 E : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
DIN EN ISO 11979-3 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 11979-2:2014	Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 14971:2007	Medical devices Application of risk management to medical devices
DIN EN ISO 11979-4 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
EN 980:2008	Symbols for use in the labelling of medical devices
DIN EN ISO 11979-1 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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DIN EN ISO 11979-9 E : 2014

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

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