OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008)

Amended by

BS EN ISO 11979-4:2008+A1:2012

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

Publisher

British Standards Institution

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	CH/172/7
DevelopmentNote	Supersedes 97/565186 DC (05/2005) Supersedes 07/30169940 DC. (02/2009) 2008 Edition Re-Issued in November 2012 & incorporates AMD 1 2012. Supersedes 11/30227516 DC. (11/2012)
DocumentType	Standard
Pages	12
PublisherName	British Standards Institution
Status	Current
Supersedes	07/30169940 DC : 0 BS EN ISO 11979-4:2000 97/565186 DC : JAN 98 11/30227516 DC : 0

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
UNI EN ISO 11979-4 : 2012	Identical
NF EN ISO 11979-4 : 2009 AMD 1 2012	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

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BS EN ISO 11979-4 : 2008

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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