UNI EN ISO 11979-4 : 2012
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION
22-11-2012
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 |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| 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 |
| 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 |
| 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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