UNI EN ISO 11979-9 : 2014

Name: UNI EN ISO 11979-9 : 2014
Brand: UNI

Superseded

View Superseded by

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES

Superseded date

08-30-2022

Published date

01-01-2014

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

Pertains to any intraocular lens whose optic provides two or more rotationally symmetric 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	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 11979-7:2018
Supersedes	UNI EN ISO 11979-9 : 2006

Standards	Relationship
I.S. EN ISO 11979-9:2006	Identical
NF EN ISO 11979-9 : 2006 AMD 1 2014	Identical
NBN EN ISO 11979-9 : 2006 AMD 1 2014	Identical
EN ISO 11979-9:2006/A1:2014	Identical
NEN EN ISO 11979-9 : 2006 AMD 1 2014	Identical
BS EN ISO 11979-9 : 2006	Identical
I.S. EN ISO 11979-9:2006&A1:2014	Identical
NS EN ISO 11979-9 : 2006 AMD 1 2014	Identical
ISO 11979-9:2006	Identical
DIN EN ISO 11979-9:2014-12	Identical
SN EN ISO 11979-9 : 2006 AMD 1 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