Name: UNI EN ISO 11979-4 : 2012
Brand: UNI

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION

Published date

11-22-2012

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information provision
5 Labelling
6 Package insert
7 Self-adhesive label
8 Use of symbols
9 Additional information
Bibliography

Describes the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.

Committee	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN ISO 11979-4 : 2009

Standards	Relationship
EN ISO 11979-4:2008/A1:2012	Identical
ISO 11979-4:2008	Identical
NEN EN ISO 11979-4 : 2009 AMD 1 2012	Identical
I.S. EN ISO 11979-4:2008	Identical
DIN EN ISO 11979-4:2013-01	Identical
NS EN ISO 11979-4 : 2008 AMD 1 2012	Identical
NBN EN ISO 11979-4 : 2009 AMD 1 2012	Identical
SN EN ISO 11979-4 : 2009 AMD 1 2012	Identical
UNE-EN ISO 11979-4:2009	Identical
NF EN ISO 11979-4 : 2009 AMD 1 2012	Identical
BS EN ISO 11979-4 : 2008	Identical
DIN EN ISO 11979-4 E : 2013	Identical

ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 11979-1:2006	Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008	Symbols for use in the labelling of medical devices