DIN EN ISO 11979-4:2013-01
Current
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
Available format(s)
Hardcopy , PDF
Language(s)
English, German
Published date
01-01-2013
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Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Bereitstellung der Informationen
5 Etikettierung
6 Beipackzettel
7 Selbstklebendes Etikett
8 Verwendung von Symbolen
Literaturhinweise
Describes the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
| Committee |
TC 172
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11979-4:2008 | Identical |
| NEN EN ISO 11979-4 : 2009 AMD 1 2012 | Identical |
| NBN EN ISO 11979-4 : 2009 AMD 1 2012 | 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 |
| I.S. EN ISO 11979-4:2008 | Identical |
| NS EN ISO 11979-4 : 2008 AMD 1 2012 | Identical |
| SN EN ISO 11979-4 : 2009 AMD 1 2012 | Identical |
| UNE-EN ISO 11979-4:2009 | Identical |
| DIN EN ISO 11979-1:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012) |
| DIN EN ISO 11979-5:2010-11 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
| DIN EN ISO 11979-9:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014) |
| DIN EN ISO 11979-3:2013-04 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012) |
| DIN EN ISO 11979-6:2015-02 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
| DIN EN ISO 11979-2:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014) |
| DIN EN ISO 11979-8:2016-04 (Draft) | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| DIN EN ISO 11979-10:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014) |
| DIN EN ISO 11607-1:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
| DIN EN ISO 11979-3:2013-04 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012) |
| DIN EN ISO 11979-1:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012) |
| DIN EN ISO 15223-1:2015-08 (Draft) | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| DIN EN ISO 11979-9:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014) |
| DIN EN ISO 11979-10:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014) |
| DIN EN ISO 11979-2:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014) |
| DIN EN ISO 11979-5:2010-11 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| DIN EN 980:2008-08 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| DIN EN ISO 11607-2:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
| DIN EN 1041:2013-12 | Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| DIN EN ISO 11979-6:2015-02 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
| DIN EN ISO 11979-8:2016-04 (Draft) | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| DIN EN ISO 11979-7:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014) |
| 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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