DIN EN ISO 11979-10:2014-12
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014)
Hardcopy , PDF
31-08-2018
English, German
01-01-2014
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National foreword
National Annex NA (informative) - Bibliography
Foreword to EN ISO 11979-10:2006
Foreword to EN ISO 11979-10:2006/A1:2014
1 Scope
2 Normative references
3 Terms and definitions
4 Optical requirements
5 Mechanical requirements
6 Clinical investigation
7 Information supplied by the manufacturer
Annex A (informative) - Clinical investigation
Annex B (informative) - Statistical sample size
considerations
Bibliography
Pertains to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye.
| DevelopmentNote |
DRAFT 2017 issued in February 2017. (02/2017)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| UNE-EN ISO 11979-10:2007 | Identical |
| NEN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| UNI EN ISO 11979-10 : 2015 | Identical |
| SN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| I.S. EN ISO 11979-10:2007 | Identical |
| NBN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NS EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| ISO 11979-10:2006 | Identical |
| ONORM EN ISO 11979-10 : 2014 | Identical |
| BS EN ISO 11979-10 : 2006 | Identical |
| EN ISO 11979-10:2018 | 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 11979-7:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014) |
| 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 11979-4:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012) |
| DIN EN ISO 11979-8:2016-04 (Draft) | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| 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) |
| ISO 11979-7:2014 | Ophthalmic implants Intraocular lenses Part 7: Clinical investigations |
| DIN EN ISO 11979-4:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012) |
| DIN EN ISO 11979-2:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 11979-3:2012 | Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| DIN EN ISO 14155:2012-01 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
| ISO 11979-4:2008 | Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 11979-2:2014 | Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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