EN ISO 11979-4:2008/A1:2012
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 1:2012)
01-10-2012
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 |
TC 170
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Supersedes |
Standards | Relationship |
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 |
I.S. EN ISO 11979-4:2008&A1:2012 | Identical |
DIN EN ISO 11979-4 E : 2013 | 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 |
PN EN ISO 11979-4 : 2010 AMD 1 2013 | 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 |
BS EN ISO 11979-4 : 2008 | Identical |
ISO 11979-4:2008/Amd 1:2012 | Identical |
BS EN ISO 11979-4:2008+A1:2012 | Identical |
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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