I.S. EN ISO 11979-9:2006

Withdrawn

View Superseded by

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)

Withdrawn date

13-05-2021

Published date

01-01-2006

Publisher

National Standards Authority of Ireland

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
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

Define 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
PublisherName	National Standards Authority of Ireland
Status	Withdrawn
SupersededBy	I.S. EN ISO 11979-9:2006&A1:2014

Standards	Relationship
DIN EN ISO 11979-9:2014-12	Identical
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
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 11979-9 E : 2014	Identical

ISO 11979-7:2014	Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
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
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
EN 980:2008	Symbols for use in the labelling of medical devices
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied