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EN ISO 11979-4:2008/A1:2012

Current
Current

The latest, up-to-date edition.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 1:2012)
Published date

10-01-2012

Publisher

Comite Europeen de Normalisation

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
TC 170
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
EN 13503-3 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
I.S. EN 13503-3:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
I.S. EN ISO 11979-8:2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
I.S. EN 13503-6:2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
BS EN 13503-3:2000 Ophthalmic implants. Intraocular lenses Mechanical properties and test methods
BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
BS EN 13503-6:2002 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability
EN 13503-6 : 2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY

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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