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BS EN ISO 11979-4 : 2008

Current
Current

The latest, up-to-date edition.

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

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

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

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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