Name: UNI EN ISO 11979-10 : 2015
Brand: UNI

UNI EN ISO 11979-10 : 2015

Superseded

View Superseded by

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES

Superseded date

03-16-2019

Published date

01-01-2015

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Optical requirements
5 Mechanical requirements
6 Clinical investigation
7 Information supplied by the manufacturer
Annex A (informative) - Clinical investigation
Annex B (informative) - Statistical sample size
considerations
Bibliography

Pertains to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye.

Committee	U42.00.06
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 11979-10 : 2018
Supersedes	UNI EN ISO 11979-10 : 2007

Standards	Relationship
NEN EN ISO 11979-10 : 2006 AMD 1 2014	Identical
NS EN ISO 11979-10 : 2006 AMD 1 2014	Identical
I.S. EN ISO 11979-10:2007	Identical
ONORM EN ISO 11979-10 : 2014	Identical
SN EN ISO 11979-10 : 2006 AMD 1 2014	Identical
UNE-EN ISO 11979-10:2007	Identical
BS EN ISO 11979-10 : 2006	Identical
DIN EN ISO 11979-10:2014-12	Identical
ISO 11979-10:2006	Identical
NF EN ISO 11979-10 : 2006 AMD 1 2014	Identical
NBN EN ISO 11979-10 : 2006 AMD 1 2014	Identical
EN ISO 11979-10:2018	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 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
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